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Epidemiology and Research Review: Dr. Galvez PLM Notes
Epidemiology and Research Review: Dr. Galvez PLM Notes
and Research
Review
Dr. Galvez
PLM notes
What form of consent does the patient give when he
agrees to surgery but need not consent specifically
to the anesthetic to be used?
a. informed
b. presumed
c. surrogate
d. none of the above
Types of Consent:
A. Informed Consent: when a competent individual
makes decisions for her or himself.
Elements:
I. Information
a) the purpose of the procedure.
d) the anticipated results.
b) risks and benefits.
c) alternative procedures
II. Comprehension
a) adapted to the subjects' capacities
b) the more serious the risk, more
important full comprehension
III. Freedom
a) the subject understands the situation
b) no coercion is used
Types of Consent:
B. Presumed Consent: when a person is unable to
give consent of their own accord, but it is
reasonable to believe they would consent if able
Precision refers to
how closely
individual
measurements agree
with each other
The ability of the test to pick up or label positive
those who have the disease is:
a. sensitivity
b. precision
c. specificity
d. accuracy
The following essential elements are part of the
research question format EXCEPT:
a. adequate technical expertise
b. biologic and/or theoretical rationale
c. study population
d. primary outcome of interest
"Among young children with acute
asthma exacerbation, is a single dose
of IM dexamethasone comparable to
five days of oral prednisolone for
resolution of asthma symptoms?"
PIOM (PICO)
P – patient/study population
I – intervention/exposure
O – outcome/disease
M – method/comparison
The Research Question Format: 6 essential elements
disease occurs at
greater than
expected frequency
Index Case
Person that comes to the attention of
public health authorities
Primary Case
Person who acquires the disease
from an exposure
Attack rate
Secondary Case
Person who acquires the disease
from an exposure to the primary case
Secondary attack rate
Epidemiological parameters
A. Basic reproductive number, Ro
- the average number of secondary cases
generated by an index case when
an epidemic begins
B. Mean Generation Time, Tg
- the average time it takes an index case to infect
other individuals after he becomes infected.
- indicates how long it takes for an individual to
spread his infection
Descriptive
-provides a picture of the occurrence of the
disease or condition to be able to come up
with a hypothesis regarding its causation
Analytical
-offers to explain the reasons for the
occurrences of relationships between
disease and purported causative factors
Study Designs
Descriptive studies
Case Report
Case Series
Ecological
Cross-sectional
Study Designs
Analytical
Observational
Cross-sectional
Case-control
Cohort
Experimental
Case Reports
PIOM (PICO)
P – patient/study population
I – intervention/exposure
O – outcome/disease
M – method/comparison
Objectives of the research tell:
a. what variables are being considered
b. the affirmation of the hypothesis
formulated
c. when the biostatistician must come in
d. how much fund to request
Controlled studies mean:
a. an experiment is being done
b. there is a comparison group
c. the characteristics of the participant are
all the same
d. a group is not to be given the experimental
procedure
Controlled Trials
EXTERNAL validity
- extent to which the investigator is able
to generalize the results of the study
- results can be applied to the whole
population
Data Analysis
Involves quantification, description
and determination of relationships
of variables
IMPORTANCE:
Types:
I. Observational
a. Cross-sectional
b. Case-control
c. Cohort
II. Experimental
Cross-sectional Studies
Description
ED
ED
N n
ED
ED
Case-control Studies
• Studies where persons with a particular
disease (the cases) and persons without the
disease (the controls) are selected and
exposure of interest are then determined
and compared
• Identify possible causes of disease
• Uses Odds Ratio as an effect measure
Case-Control Design
Description
E
D
E
E
D
E
Direction of Inquiry
Cohort Studies
Studies wherein a group or groups of individuals
who are free of the outcome of interest are
classified according to their exposure to a
suspected risk factor and followed-up over a
period of time for the development of the
outcome of interest
Identify risk factors, protective factors and
prognostic factors for disease
Describe the natural history of disease
Uses Risk Ratio as an effect measure
Cohort Design
Description
D
E
D
D
E
D
Direction of Inquiry
Cohort Studies
• Prospective – begins at the present and
proceeds forward to the future
• Retrospective – begins in the past and
proceeds forward to a more recent past
• Ambispective – begins in the past and
proceeds forward to the future
Feature Cohort Case-Control
Starting Exposed group Diseased group
population
Control Unexposed group Non-diseased group
population
Information Disease rate (incidence Proportion with past
sought or mortality) exposure to suspected
factor
Principal bias Knowledge of Knowledge of disease
exposure may may influence report of
influence diagnosis exposure
Time required to Usually long (except Short period
collect data for retrospective
cohort)
Measure of Risk of disease for Odds ratio
association individuals
Experimental Studies
Random Sample
Randomization
a. descriptive study
b. cohort study
c. case-control
d. cross-sectional
A study is planned to determine if there are more
users of oral contraceptives among patients with
thrombophlebitis than among well persons. To
achieve the objective, which of the following type of
studies is most appropriate:
a. clinical
b. descriptive
c. concurrent cohort
d. case control
In a cohort study of the association of leukemia
with x-ray exposure, the relative risk was found to
be 3. What does this mean?
a. Those with x-ray exposure have threefold
probability of developing leukemia.
b. X-ray exposure protects the person from
developing leukemia.
c. There is no association between x-ray
exposure and leukemia.
d. None of the above.
Cohort Studies
Analysis of Results:
Null value of 1 = no association between
exposure and outcome
RR > 1 <= harmful effect
RR < 1 <= protective or beneficial effect
In a cohort study of the association of leukemia
with x-ray exposure, the relative risk was found to
be 3. What does this mean?
a. Those with x-ray exposure have threefold
probability of developing leukemia.
b. X-ray exposure protects the person from
developing leukemia.
c. There is no association between x-ray
exposure and leukemia.
d. None of the above.
It is important to formulate a research hypothesis
particularly when doing analytic studies because it
helps the researcher in:
a. identifying the most appropriate study
design to use.
b. determining the best approach to how
subjects are to be selected
c. anticipating the appropriate statistical
analysis to use
d. estimating the sample size for the study
Research Objectives
General objective
• identifies in general terms what is to
be accomplished by the study
Specific objective
• identifies in specific details on how to
accomplish the research by using
measurable parameters
90
Research Design
“Plan of attack”
Includes subject selection, sample size,
control and manipulation of variables,
outcome evaluation, instrumentation,
plan of analysis
Important to achieve internal and
external validity
91
Research Hypothesis
92
Research Hypothesis
Example:
obesity hypertension
age
93
It is important to formulate a research hypothesis
particularly when doing analytic studies because it
helps the researcher in:
a. identifying the most appropriate study
design to use.
b. determining the best approach to how
subjects are to be selected
c. anticipating the appropriate statistical
analysis to use
d. estimating the sample size for the study
The peculiar feature of a cross-sectional study that
distinguishes it from other study designs is:
a. Information on both the independent and
dependent variable are collected simultaneously
at the time of the survey
b. Information on the independent variable is
collected first, after which the subjects are
followed up later for assessment of the dependent
variable
c. Information on the dependent variable is
obtained, after which assessment of the
independent variable is made
d. Information on both the independent and
dependent variable are obtained by doing either
queries or actual observation
The peculiar feature of a cross-sectional study that
distinguishes it from other study designs is:
a. Information on both the independent and
dependent variable are collected simultaneously
at the time of the survey
b. Information on the independent variable is
collected first, after which the subjects are
followed up later for assessment of the dependent
variable
c. Information on the dependent variable is
obtained, after which assessment of the
independent variable is made
d. Information on both the independent and
dependent variable are obtained by doing either
queries or actual observation
The effect of an inadequate sample size for a study
is:
a. Subjects may not be a random representative
of the base population
b. there may not be enough subjects that will
develop the outcome, in order to detect a
difference.
c. the researcher will not be able to apply the
appropriate statistical test for the kind of
data available.
d. the researcher might find an association
between independent and dependent
variables, even if there is actually none.
Sample size
Secondary Data
● data gathered from other sources
● cheap and easy to collect but must be
treated with caution
Which method of collecting data results to
accumulation of “secondary data”;
a. self-administered questionnaire
b. observation
c. measurement
d. review of documents
The following statements are true regarding bias:
a. it may result both from biologic as well as
measurement variations
b. it is a systematic deviation from the true
underlying value
c. it may result from sampling error
d. all of the above
BIAS
• Systematic, random deviation of results
• Information Bias
recall bias
interviewer bias
• Confounding
• Publication
The following statements are true regarding bias:
a. it may result both from biologic as well as
measurement variations
b. it is a systematic deviation from the true
underlying value
c. it may result from sampling error
d. all of the above
A disease that occurs at an unusual or unexpected
number is said to be:
a. epidemic
b. endemic
c. sporadic
d. any of the above
Temporal patterns of disease
1. Endemic
disease occurs at expected frequency
2. Epidemic
disease occurs at greater than expected
frequency
3. Pandemic
huge epidemic (international)
4. Sporadic
single case or small cluster of cases
A disease that occurs at an unusual or unexpected
number is said to be:
a. epidemic
b. endemic
c. sporadic
d. any of the above
An epidemiologic study provides clues for disease
etiology and hypothesis for further study is called:
a. cross-sectional study
b. cohort study
c. descriptive study
d. case-control study
Study Designs
Descriptive
-provides a picture of the occurrence of the
disease or condition to be able to come up
with a hypothesis regarding its causation
Analytical
-offers to explain the reasons for the
occurrences of relationships between
disease and purported causative factors
An epidemiologic study provides clues for disease
etiology and hypothesis for further study is called:
a. cross-sectional study
b. cohort study
c. descriptive study
d. case-control study
Prevalence is defined as the rate at which disease
occurs in a population over time. It is composed of:
a. old cases
b. new cases
c. old and new cases
d. old and selected new cases
Prevalence
• Measures the proportion of individuals in a
population with the disease/condition at a given
time
122
Prevalence
• Two types
– Point Prevalence
– Period Prevalence
Total population
123
Incidence
• Unlike the prevalence, the incidence
measure deals with new cases only
1. Cumulative Incidence or
Incidence Proportion (fixed
cohort)
124
2. Incidence Density (dynamic cohort)
Incidence
Conduct of a Cohort Study
Fixed Cohort
All members of the cohort are gathered at
the beginning of the study and there are no
additional members after the study starts
All members of the cohort are followed up for
the specified period of time
Dynamic Cohort
• Membership is not fixed at the start of the study
• Recruitment process goes on even after some
members are already being followed-up
125
Incidence
1. Cumulative Incidence or Incidence Proportion
No. of new cases of a dse at the given time pd
No. of dse-free indvs at the start of the period
Total Person-Time
Prevalence is defined as the rate at which disease
occurs in a population over time. It is composed of:
a. old cases
b. new cases
c. old and new cases
d. old and selected new cases
If you are a Municipal Health Officer and
investigation an epidemic of pneumonia in an
evacuation center, the rate than you are going to
use to determine number of beds to be used,
medicines to bring, number of manpower to deploy
is:
a. prevalence rate
b. incidence rate
c. secondary attack rate
d. specific death rate by cause
Incidence Rate
No t c d
exposed
Total
No t c 10 d 90 100
exposed
Total 30 170 200
• Characteristics of a confounders
– Is a risk factor to the disease /outcome
– Must be associated with the exposure
– Not an intermediate variable
CONTROLLING FOR BIASES
• Control of Confounding
1. At the design stage
• Randomization (for exp designs)
• Restriction of the inclusion criteria
• Matching
Effectiveness
• intervention works and produces the expected result
under “real world” clinical settings
• “real world” studies of therapy as performed outside
research studies (techniques, populations)
• good generalization to real life patient populations and
real-life treatment methods (high external validity)
This describes true treatment of intervention under
ideal conditions:
a. efficacy
b. effectiveness
c. reliability
d. validity
Metaanalysis may be used for the following reasons
EXCEPT:
a. decide on the best clinical approach to a
problem based on a several related studies
b. scrutinize studies to explain why research
differ
c. to report unusual event or unexpected
events
d. identify new directions for research
Metaanalysis
the statistical technique for combining results from
individual studies for the purpose of integrating the
findings
used to assess the clinical effectiveness of health care
interventions
provides a precise estimate of treatment effect, giving
due weight to the size of different studies included
good meta-analyses aim for complete coverage of all
relevant studies, look for the presence of heterogeneity,
and explore the robustness of the main findings using
sensitivity analysis.
Metaanalysis may be used for the following reasons
EXCEPT:
a. decide on the best clinical approach to a
problem based on a several related studies
b. scrutinize studies to explain why research
differ
c. to report unusual event or unexpected
events
d. identify new directions for research
Who among the following is the reference
population in a research study to test the
effectiveness of a vaccine against tetanus
neonatorum?
a. all neonates without tetanus
b. mother who has tetanus
c. all patients with tetanus
d. All neonates with tetanus
Experimental Studies
REFERENCE VS. EXPERIMENTAL POPULATIONS
• Reference population - the population to
which one would like to generalize the
results of the experimental study
• Experimental population – the population
that is actually studied
Who among the following is the reference
population in a research study to test the
effectiveness of a vaccine against tetanus
neonatorum?
a. all neonates without tetanus
b. mother who has tetanus
c. all patients with tetanus
d. All neonates with tetanus
Prevalence rate is generally used to measure:
a. chronic diseases
b. accidents
c. socio-economic status
d. disabilities
Prevalence
• Measures the proportion of individuals in a
population with the disease/condition at a given
time
163
Prevalence rate is generally used to measure:
a. chronic diseases
b. accidents
c. socio-economic status
d. disabilities
Cohort perspective has the following disadvantages:
a. time-consuming and expensive
b. can readily establish a cause-effect
relationship
c. the risks are accurate
d. occurrence of the illness is readily observed
Cohort Studies
ADVANTAGES
• More clearly established temporal sequence
• Direct calculation of exposure-specific incidence
rates
• Can look at multiple effects of a single exposure
• Suitable for studies of rare exposures
• Certain biases are minimized especially regarding
ascertainment of exposure
Cohort Studies
DISADVANTAGES
• Generally more expensive
• May require long follow-up periods
• Requires large sample sizes
• Susceptible to follow-up bias
Cohort perspective has the following disadvantages:
a. time-consuming and expensive
b. can readily establish a cause-effect
relationship
c. the risks are accurate
d. occurrence of the illness is readily observed
This describes the population of true abnormal or
test-positives correctly identified:
a. Sensitivity
b. Specificity
c. Bias
d. Reliability
9 5
1 95
aa da
Sn = a/a+c a+c b+d
This describes the population of true abnormal or
test-positives correctly identified:
a. Sensitivity
b. Specificity
c. Bias
d. Reliability