Module 1-3 Flashcards

1
Q

a state of complete physical, mental and
social well-being and not merely the
absence of disease or infirmity.

A

Health

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2
Q

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

A

Public Health

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3
Q

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

A

T

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4
Q

From the early beginnings of human civilization, it was recognized
that __ may spread
vector-borne diseases?

A

polluted water & lack of proper waste disposal

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5
Q

Rules governing medical practice

A

1700 BC The Code of Hammurabi

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6
Q

Personal, food and camp hygiene, segregating lepers, overriding
duty of saving of life (Pikuah Nefesh) as religious imperatives.

A

1500 BC Mosaic Law

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7
Q

Personal hygiene, fitness, nutrition, sanitation, municipal doctors,
occupational health; Hippocrates –clinical and
epidemic observation and environmental health

A

400 BC Greece

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8
Q

aqueducts, baths, sanitation, municipal planning, and sanitation services, public baths, municipal doctors, military
and occupational health.

A

500 BC to AD 500 Rome

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9
Q

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.

A

500 – 1000 Europe

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10
Q

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.

A

1348 – 1350 Black Death

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11
Q

bubonic plague, smallpox, leprosy, diphtheria, typhoid, measles, influenza, tuberculosis, anthrax, trachoma, scabies and others
until eighteenth century

A

1300 Pandemic

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12
Q

microscope, observes sperm and bacteria.

A

1673 Antony van Leeuwenhoek

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13
Q

first vaccination against smallpox.

A

1796 Edward Jenner

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14
Q

growth of science.

A

1830 Sanitary and social reform

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15
Q

waterborne cholera in London: the Broad Street Pump, Father of epidemiology; founded the science of epidemiology

A

1854 John Snow

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16
Q

modern nursing and hospital reform – Crimean War

A

1854 Florence Nightingale

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17
Q

He proves no spontaneous generation of life.

A

1858 Louis Pasteur

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18
Q

publishes On the Origin of Species.

A

1859 Charles Darwin

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19
Q

He publishes findings on microbial causes of disease.

A

1862 Louis Pasteur

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20
Q

He discovered anthrax bacillus.

A

1876 Robert Koch

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21
Q

He discovered gonococcus organism.

A

1879 Neisser

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22
Q

He discovered the tuberculosis organism, tubercle bacillus.

A

1882 Robert Koch

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23
Q

He discovered bacillus of cholera.

A

1883 Robert Koch

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24
Q

Vaccinates against anthrax

A

1883 Louis Pasteur

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25
Q

Gas gangrene organism discovered by

A

1892 Welch and Nuttal

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26
Q

Pertussis vaccine developed

A

1926

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27
Q

Alexander Fleming discovers penicillin

A

1928

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28
Q

wide spread economic collapse, unemployment,
poverty, and social distress in industrialized
countries.

A

1929 – 1936 The Great Depression

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29
Q

World Health Organization was founded on year?

A

1946

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30
Q

WHO declares eradication of smallpox
achieved

A

1979

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31
Q

First recognition of cases of acquired immune deficiency syndrome (AIDS).

A

1981

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32
Q

W.F. Anderson performs first successful gene therapy.

A

1990

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33
Q

brief document that recognizes primary health care as a means to achieving the objective of health for all people of all nations.

A

Alma Ata Declaration

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34
Q

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.

A

Alma Ata Declaration

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35
Q

Core Functions of Public Health:

A

Assessment: of the health of the community
Policy Development: in the public interest
Assurance: of the public’s health

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36
Q

Systematically collect, analyze, and make available information on healthy communities

A

Assessment

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37
Q

Promote the use of a scientific knowledge
base in policy and decision making

A

Policy Development

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38
Q

Ensure provision of services to those in need

A

Assurance

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39
Q

failure of the body defense mechanism to cope with forces tending to disturb body equilibrium

A

Disease

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40
Q

science of theory of the causes or origins of diseases

A

Etiology

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41
Q

study of the distribution of disease and the factors that influence the occurrence of disease in groups of people

A

Epidemiology

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42
Q

is an organized plan of services.

A

Health care system

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43
Q

responsible for the maintenance of the Barangay Health Center and provision of servicesand facilities
related to general hygiene

A

Barangay

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44
Q

for primary health care programs, establishment of clinics and health centers, and provision of services and facilities related to general hygiene

A

City or Municipality Government

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45
Q

is mandated to assist the municipal and barangay government through hospitals and pollution control systems

A

Provincial Government

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46
Q

composed of barangay, municipal, and medicare healthcare institutions, which have facilities and capabilities for first emergency care

A

Primary Level

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47
Q

consists of district healthcare institutions with capabilities and facilities for medical care of cases requiring hospitalization. Municipal hospital with 50-100 bed capacity

A

Secondary Level

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48
Q

composed of specialized centers, regional healthcare institutions, and provincial. Regional medical center with complete facilities and above100-bed capacity

A

Tertiary Level

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49
Q

Primary focus on population

PUBLIC HEALTH/MEDICINE

A

PUBLIC HEALTH

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50
Q

Primary focus on individual

PUBLIC HEALTH/MEDICINE

A

MEDICINE

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51
Q

Emphasis on Prevention and Health Promotion of the whole community

PUBLIC HEALTH/MEDICINE

A

PUBLIC HEALTH

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52
Q

Emphasis on Diagnosis and Treatment of the whole patient

PUBLIC HEALTH/MEDICINE

A

MEDICINE

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53
Q

Paradigm: Intervention aimed at environment, human
behavior and lifestyle, medical care.

PUBLIC HEALTH/MEDICINE

A

PUBLIC HEALTH

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54
Q

Paradigm: Medical care

PUBLIC HEALTH/MEDICINE

A

MEDICINE

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55
Q

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

A

PUBLIC HEALTH

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56
Q

Organizational Lines of Specialization:
-Organs
-Patient group
-Etiology, pathophysiology
-Technical skills

PUBLIC HEALTH/MEDICINE

A

MEDICINE

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57
Q

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

A

Epidemiology

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58
Q

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

A

Epidemiology

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59
Q

often described as the basic science of public health”

A

Epidemiology

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60
Q

refers not only to the number of health events

A

Frequency

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61
Q

refers to the occurrence of health-related events by time, place, and person.

A

Pattern

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62
Q

the causes and other factors that influence the occurrence of disease and other health-related events.

A

Determinants

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63
Q

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.

A

Epidemiology

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64
Q

is the ongoing, systematic collection, analysis, interpretation, and dissemination of health data to help guide public health decision making and action.

A

Public health surveillance

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65
Q

One of the first actions that results from a surveillance
case report or report of a cluster is investigation by the
public health department.

A

Field investigation

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66
Q

Clusters or outbreaks of disease frequently are
investigated initially with

Descriptive epidemiology
Analytic epidemiology

A

Descriptive epidemiology

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67
Q

the use of a valid comparison group.

Descriptive epidemiology
Analytic epidemiology

A

Analytic epidemiology

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68
Q

the process of determining, as systematically and objectively as possible, the relevance, effectiveness, efficiency, and impact of activities with respect to established goals

A

Evaluation

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69
Q

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

A

Effectiveness

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70
Q

refers to the ability of the program to produce the intended results with a minimum expenditure of time and resources.

Efficiency
Effectiveness

A

Efficiency

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71
Q

To promote current and future collaboration, the epidemiologists need to maintain relationships with staff of other agencies and institutions.

A

Linkages

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72
Q

Epidemiologists working in public health regularly provide input, testimony, and recommendations regarding disease control strategies, reportable disease regulations, and
health-care policy.

A

Policy Development

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73
Q

aims to describe the distributions of diseases and determinants.

Descriptive epidemiology
Analytic epidemiology

A

Descriptive epidemiology

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74
Q

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

A

Descriptive epidemiology

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75
Q

3 epidemiologic variables:

A

Time
Place
Person

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76
Q

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

A

Time

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77
Q

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

A

Secular (long-term) trends

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78
Q

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

A

Day of week and time of day

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79
Q

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

A

Epidemic period

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80
Q

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

A

Seasonality

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81
Q

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

A

Place

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82
Q

“Person” attributes include age, sex, ethnicity/race, and socioeconomic status.

Time
Place
Person

A

Person

83
Q

Person Attribute:

A

Age
Sex
Ethnic and Racial Groups
Socioeconomic Status

84
Q

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

A

Age

85
Q

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

A

Sex

86
Q

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

A

Ethnic and Racial Groups

87
Q

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

A

Socioeconomic Status

88
Q

The key feature of analytic epidemiology is a
_______?

A

comparison group

89
Q

concerned with the search for causes and effects, or the why and the how. Epidemiologic studies fall into two categories:
____ and _____.

A

experimental
observational

90
Q

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.

A

COHORT STUDY

91
Q

An alternative type of cohort study is a ______. In this type of study both the exposure and the outcomes have already occurred.

A

retrospective cohort study

92
Q

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.

A

CROSS-SECTIONAL STUDY

93
Q

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.

A

Epidemiologic Triangle

94
Q

s consistent with the infectious disease process, but it can also
be applied to chronic noninfectious diseases

A

Triangle Model

95
Q

refers to a disease that occurs infrequently and irregularly.

Endemic
Sporadic
Epidemic
Hyperendemic

A

Sporadic

96
Q

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

A

Endemic

97
Q

refers to persistent, high levels of disease occurrence.

Endemic
Sporadic
Epidemic
Hyperendemic

A

Hyperendemic

98
Q

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

A

Epidemic

99
Q

carries the same definition of epidemic, but is often used for a more limited geographic area.

Cluster
Outbreak
Pandemic

A

Outbreak

100
Q

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

A

Cluster

101
Q

refers to an epidemic that has spread over several countries or continents, usually affecting a large number of people

Cluster
Outbreak
Pandemic

A

Pandemic

102
Q

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

A

common-source

103
Q

If the group is exposed over a relatively brief period

point-source outbreak
intermittent common-source outbreak
continuous common-source outbreak - case

A

point-source outbreak

104
Q

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

A

continuous common-source outbreak - case

105
Q

has a pattern reflecting the intermittent nature of the
exposure

point-source outbreak
intermittent common-source outbreak
continuous common-source outbreak - case

A

intermittent common-source outbreak

106
Q

results from transmission from one person to another. Transmission is by direct person-to-person contact

Common-source
Propagated
Mixed

A

Propagated Outbreak

107
Q

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

A

Mixed Epidemics

108
Q

_____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

A

Frequency Measures

109
Q

refer to the number of cases of a disease or other health event under study

Frequency Measures
Proportions
Prevalence
Incidence
Counts
Ratio
Rate

A

Counts

110
Q

is the relative magnitude of two quantities

Frequency Measures
Proportions
Prevalence
Incidence
Counts
Ratio
Rate

A

Ratio

111
Q

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

A

Proportions

112
Q

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

A

Rate

113
Q

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

A

Incidence

114
Q

refers to frequency of existing cases in a defined population at a given point in time

Frequency Measures
Proportions
Prevalence
Incidence
Counts
Ratio
Rate

A

Prevalence

115
Q

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.

A

Morbidity

116
Q

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

A

mortality rate

117
Q

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

A

crude mortality rate

118
Q

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

A

cause-specific mortality rate

119
Q

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

A

age-specific mortality rate

120
Q

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

A

infant mortality rate

121
Q

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

A

infant mortality rate

122
Q

covers birth up to but not including 28 days

neonatal period
postneonatal period

A

neonatal period

123
Q

defined as the period from 28 days of age up to but not
including 1 year of age

neonatal period
postneonatal period

A

postneonatal period

124
Q

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

A

maternal mortality rate

125
Q

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

A

sex-specific mortality rate

126
Q

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

A

race-specific mortality rate

127
Q

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

A

mortality rates

128
Q

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

A

death-to-case ratio

129
Q

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

A

case-fatality rate

130
Q

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

A

Proportionate mortality

131
Q

study of uses and drug effects in a defined population

A

Pharmacoepidemiology

132
Q

“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”

A

Pharmacoepidemiology

133
Q

Examines real world = experience; Mainly relies on observational research

A

Pharmacoepidemiology

134
Q

Pharmacoepidemiology involves disciplines such as:

A

epidemiology, clinical pharmacology and biostatistics

135
Q

Father of modern medicine. Coined the term ‘endemic’ and promoted clean hands for wound management.

A

40 BC Hippocrates

136
Q

Father of modern epidemiology; work in tracing the source of a cholera outbreak in Soho, England.

A

1854 John Snow

137
Q

British Surgeon. Discovered antiseptic (carbolic acid) as an antiseptic by applying Louis Pasteur’s advances in microbiology.

A

1865 Joseph Lister

138
Q

Introduced mathematical methods in epidemiology

A

Early 20th Century Ronald Rose & his team

139
Q

Molecular epidemiology focusing on the relationship between biomarker and disease evolved.

A

Later 20th Century Ronald Rose & his team

140
Q

US govt passed pure Food and Drug act in response to excessive adulteration and misbranding of food and drugs

A

1906

141
Q

people died from renal failure due as a result of the elixir sulfanilamide dissolved in diethylene glycol

A

1937

142
Q

Drug and Cosmetics Act was passed

A

1938

143
Q

Thalidomide tragedy

A

1950-1960s

144
Q

UK established a committee on safety of medicines

A

1968

145
Q

WHO established a bureau to collect and analyze information and similar national drug monitoring organizations

A

1968

146
Q

Kefauver-Harris Amendments

A

1962

147
Q

related field of drug utilization was developed along with the study of ADRs
– considered to be the beginning of field of pharmacoepidemiology

A

1960

148
Q

obtain more data on risk and benefits of drugs in population and to discuss, develop & disseminate information

A

ISPE (International Society for Pharmacoepidemiology)

149
Q

Activities related to ISPE:

A
  • Pharmacovigilance
  • Drug utilization research and outcome
    research
  • therapeutic risk management
150
Q

is an area unique to pharmacoepidemiology and it is a type of
continual monitoring of unwanted effects and other safety-related aspects of drugs.

A

Pharmacovigilance

151
Q

Randomized clinical trials

Experimental/Non-experimental

A

Experimental

152
Q

Field trials

Experimental/Non-experimental

A

Experimental

153
Q

Community intervention trials

Experimental/Non-experimental

A

Experimental

154
Q

Prospective cohort

Experimental/Non-experimental

A

Non-experimental

155
Q

Retrospective cohort

Experimental/Non-experimental

A

Non-experimental

156
Q

Case control

Experimental/Non-experimental

A

Non-experimental

157
Q

Case series

Experimental/Non-experimental

A

Non-experimental

158
Q

Case report

Experimental/Non-experimental

A

Non-experimental

159
Q

Cross sectional

Experimental/Non-experimental

A

Non-experimental

160
Q

Ecological

Experimental/Non-experimental

A

Non-experimental

161
Q

Hybrid Studies

Experimental/Non-experimental

A

Non-experimental

162
Q

Randomized

Interventional/Clinical Trial
Observational

A

Interventional/Clinical Trial

163
Q

Protocol-mandated visit & treatment schedule

Interventional/Clinical Trial
Observational

A

Interventional/Clinical Trial

164
Q

Treatment by protocol

Interventional/Clinical Trial
Observational

A

Interventional/Clinical Trial

165
Q

Restrictive entry

Interventional/Clinical Trial
Observational

A

Interventional/Clinical Trial

166
Q

Rigidly specified

Interventional/Clinical Trial
Observational

A

Interventional/Clinical Trial

167
Q

Prospective

Interventional/Clinical Trial
Observational

A

Interventional/Clinical Trial

168
Q

One primary objective

Interventional/Clinical Trial
Observational

A

Interventional/Clinical Trial

169
Q

Non-randomized

Interventional/Clinical Trial
Observational

A

Observational

170
Q

Routine care, no mandated visit & treatment schedule

Interventional/Clinical Trial
Observational

A

Observational

171
Q

Broad entry criteria

Interventional/Clinical Trial
Observational

A

Observational

172
Q

Naturalistic

Interventional/Clinical Trial
Observational

A

Observational

173
Q

Prospective and / or retrospective

Interventional/Clinical Trial
Observational

A

Observational

174
Q

Could state several objectives

Interventional/Clinical Trial
Observational

A

Observational

175
Q

Little / no monitoring

Interventional/Clinical Trial
Observational

A

Observational

176
Q

Study patients with specific disease

Community intervention trials
Randomized clinical trials
Field trials

A

Randomized clinical trials

177
Q

study subjects to prevent disease

Community intervention trials
Randomized clinical trials
Field trials

A

Field trials

178
Q

Study communities to prevent disease

Community intervention trials
Randomized clinical trials
Field trials

A

Community intervention trials

179
Q

Observe group of patients treated with the same drug

Case control
Retrospective cohort
Prospective cohort

A

Prospective cohort

180
Q

Extract data from an existing repository to look at outcomes of exposed group

Case control
Retrospective cohort
Prospective cohort

A

Retrospective cohort

181
Q

determine association between a drug and a rare event

Case control
Retrospective cohort
Prospective cohort

A

Case control

182
Q

Reveal common experience of a number of patients following drug exposure

Cross-sectional
Ecological
Case report
Case series

A

Case series

183
Q

reveal the experience of a single patient following drug exposure

Cross-sectional
Ecological
Case report
Case series

A

Case report

184
Q

Determine the prevalence of drug use in a patient population at a given time

Cross-sectional
Ecological
Case report
Case series

A

Cross-sectional

185
Q

Determine the association between drug use of a population or group and an event

Cross-sectional
Ecological
Case report
Case series

A

Ecological

186
Q

study of the effects of drugs

A

Pharmacology

187
Q

study of the effects of drugs in humans

A

Clinical Pharmacology

188
Q

therapy should be individualized which requires the determination of a risk/benefit balance

A

Central principle of clinical pharmacology

189
Q

is the study of the distribution and determinants of diseases
in populations

A

Epidemiology

190
Q

Reasons to perform Pharmacoepidemiology Studies:

A
  • Regulatory
  • Marketing
  • Legal
  • Clinical
    – Hypothesis testing
    – Hypothesis generating
191
Q

SOURCES OF PHARMACOEPIDEMIOLOGY DATA:

A

Spontaneous AE reporting
Global Drug surveillance
Case-control surveillance
Prescription event monitoring
Automated databases
Others

192
Q

all unsolicited reports of suspected AEs
– confirmed by formal epidemiological studies

A

Spontaneous reporting

193
Q

large complex databases

data mining
signal

A

data mining

194
Q

previously unrecognized hazard
– known hazard more frequent or more serious

data mining
signal

A

signal

195
Q

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

A

Case Control Surveillance

196
Q

defined from prescriptions and followed-up for a defined period as to identify all adverse events occurring in the early post-treatment period

A

Prescription Event Monitoring

197
Q

potential data sources
– Claim databases – Medical record databases – e.g. Medicaid, United Health Group

A

Automated Databases

198
Q

provide insight into disease and treatment patterns of physicians e.g National Disease and Therapeutic Index

A

Drug utilization studies

199
Q

useful in performing analysis of secular trends

A

Disease Incidence data

200
Q

collection of cases w/out controls useful for performing case-control study

A

RegistryData

201
Q

• artificial and raise logistical problems
• intended to address specific questions about drug efficacy and few for drug safety

A

Randomized Control Trial as post marketing surveillance

202
Q
  • practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market
  • important part of pharmacovigilance
A

POST MARKETING SURVEILLANCE (PMS)

203
Q

Applications of Pharmacoepidemiology:

A
  • 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