FMCH1

Observational Studies
Dr. Syquia

I. Descriptive Studies -SOURCES OF DATA:

1. Correlation (Ecologic) Studies  Population registries, census, vital records, large
2 .Case Reports/Case series surveys
3. Cross sectional studies
-MERITS:
II. Analytic studies  Quick, easy, inexpensive
Observational Analytic Studies  Acceptable for developing hypothesis
1. Cohort studies
a. Concurrent cohort -LIMITATIONS:
b. Non concurrent cohort  Ecologic fallacies
2. Case-control studies

Lecture, Audio Fallacy- erroneous occurrence, something

not ordinary/normal
GROUPS OF EPIDEMIOLOIGIC STUDIES Ecologic descriptive study- pertains to a
DESCRIPTIVE STUDIES group/population.
-describes the occurrence of disease in different communities or in Ecologic fallacy- pertains to your entire
different subgroups within a community variable or findings may point out only to a
-the amount and distribution of disease within a population or across
single person.
population groups
-the pattern of occurrence of disease or condition by person, place,  Does not look at individual (not possible to link
time
exposure to occurrence of disease in the same
-1st step in risk factors determination
person)
-provide information that can be used to test etiological hypothesis -ECOLOGIC SAMPLE:
forming  Compare the morbidities and mortalities due to
Dengvaxia-related or attributed side effects among
USES OF DESCRIPTIVE STUDIES
the countries that administered Dengvaxia
1. Trend Analysis
 Mexico, Philippines, Brazil, El Salvador,
-describe patterns of disease occurrence Paraguay, Guatemala, Peru, Indonesia,
-over time, groups of people, place Thailand, Singapore
 Study population: All individual aged 9-45
2. Healthcare Planning
years vaccinated with Dengvaxia living in the
-efficient allocation of resources
aforementioned countries
-education and prevention programs for identified target  Unit of observation: Country
population  Data collection: Secondary sources of :
 Summary/Reports data of
3. Hypothesis Generation
vaccination data, surveillance
-formulation or research questions and hypothesis
reports
-first step in risk factors determination
 Data analysis: Use of data Abstraction tool
specifically created for the study
TYPES OF DESCRIPTIVE STUDIES

1. ECOLOGIC (CORRELATION) STUDIES CASE REPORT/ CASE SERIES

-uses data from entire population to compare disease
frequencies between:
 Different groups during the same period of time
 The same population at different points in time
-measures characters that represent entire population
-comparison of groups rather than individuals
-THE UNIT OF ANALYSIS:
 GROUP (defined demographically or on the
basis of demographic variable)
Age, gender, ethnic group, nationality
 TIME
CASE REPORT
-most basic type of descriptive studies of individuals
-a comprehensive documentation of a particular patient
case
-a detailed report starting from the onset/beginning, following
the progress up to the outcome of the case
-a case may be documented this way because it is a very
rare condition or it may be a very common disorder but has
presented differently or it has progressed in a very unusual
manner
CASE SERIES
- A documentation of a collection of a group of patients
with the same diagnosis or problems

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FMCH1 Sample Size Calculation & Statistical Analysis
-PURPOSE:
 To come up with common or modal information
such that in the end a conclusion of what is most
common to all patient with the disorder of the
disease being studied can be made
 Early means to identify the presence of an
outbreak/epidemic
-MERITS (both case report/series):
 Inexpensive and easy
 Good for very rare occurrences
 Lays the ground work for future more powerful
studies
-LIMITATIONS:
 Not a true epidemiologic study because it does not
represent a whole
-CASE REPORT SAMPLE:
 The first reported case of a severe adverse reaction
on a 10 year old female after the third dose of
vaccine
CROSS SECTIONAL STUDIES
-an examinations of the relationships between disease and other
characteristics or variables of interest as they exist in a defined
population at a particular time
-also called prevalence study survey
You should be able to differentiate what is
prevalence from incidence:
Incidence- you only deal with new cases the
one that you have on hand
Prevalence- you go back and get the old
information and add the current/new
cases/information (prevalence lang ang
cross sectional studies)
-the investigator may have a problem in mind at the start and from a
population individuals with the disease in question are identified. The
investigator then characterizes those with the disease and
those without.
-USES:
 For community diagnosis/disease
 Assessment of health needs, planning, utilization
and evaluation of health care service
 For raising the question of the presence of an
association or for generation of etiological
hypothesis
 For determining of a status of disease or condition
-MERITS:
 Inexpensive, relatively quick and easy, no follow up
is required
 Good for population that are difficult to access
 No one is exposed to the causal agent because of
the study or denied a potentially beneficial therapy.
-LIMITATIONS:
 Susceptible to incidence-prevalence bias
 Measures prevalence only
 Can establish association but impossible to
determine causation
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W9T3
-CROSS SECTIONAL STUDY SAMPLE:
 Prevalence of recurrent febrile episodes among
vaccinated students of Karuhatan elementary school and
National High school in Valenzuela City from June 2016
to January 2018
ANALYTIC STUDIES
OBSERVATIONAL STUDIES
-designed to test hypothesis about the influences that determine
that some populations or some individuals within a
population are affected by a disease while others are not
COHORT STUDIES
-an observational study of a group of people with a special character or
risk factor/exposure who are followed over time to determine who
develops the outcome of interest
-the general feature of the study is that it proceeds from a suspected
cause or etiological agent to the disease outcome
-CAUSEEFFECT
-compares people exposed to the suspected cause and those not
exposed showing that a greater proportion of people develop the
disease among the exposed group than among the non-exposed
-no intervention is applied to the group
-other names: ff-up studies, incidence studies, prospective
studies, longitudinal studies, panel studies
-APPLICATIONS:
 To identify risk factors
 To identify protective factors against disease
 To identify prognostic factors for outcome of
disease
 To describe the natural history of disease
 To protect the number of new cases of disease in a
population over a period of time – good for
planning acute care services
 To assess the effectiveness of preventive
programs/measure
parameter: lesser patient getting sick
TYPES OF COHORT STUDIES
CONCEPTUAL SENSE
-presence of outcomes and risk factors
TEMPORAL SENSE
-time relationship between initiation of study and occurrence of disease
a. CONCURRENT COHORT
-the study of the exposed and unexposed groups start at the same
time
-a.k.a prospective studies
-the data on both exposure starts and disease outcomes are not
yet available at the beginning of the study  the data will be
ascertained by the investigator in the future
-EXAMPLE:
a. Incidence of severe adverse effects to Dengvaxia among adults
aged 30-45 years living in a rural or urban area
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FMCH1 Sample Size Calculation & Statistical Analysis W9T3

b. Variable of interest/exposure: type of residence

(urban/rural)

a. NON CONCURRENT COHORT

-the study on the exposed and unexposed groups CASE-CONTROL STUDIES
does not start at the same time
-a comparison of people with disease (cases) and people
-a.k.a retrospective study
without disease (controls) showing that the suspected cause occurs
--historical cohort, historical prospective
more frequently among those with the disease than those without the
-data on exposure had been collected in the
disease.
past and outcomes have all occurred before
-cases and controls are a “matched” group which is similar in all respect
the start of investigations
except for the disease
-the data comes from records
-the study begins with the absence or presence of a disease or outcome
-MERITS:
and a retrospective evaluation is conducted to determine who was
 Treatment is not withheld from subjects, they are
exposed and who was not exposed
not artificially subjected to potential hazards
-MERITS
 Subjects can be matched for possible
 Less expensive less time period for study
confounders
 Well suited to the evaluation of the disease with
Confounders: some condition that long latent period or examining conditions that
might influence the flow of your develop over a long time
 Optimal for evaluation of rare diseases
timeline (may iba pang nangyari)
-LIMITATIONS
If the disease entity lik e diabetes  Depends completely on high quality of existing
mellitus would have co-morbid records
conditions or co-morbid illnesses. Ex.  Particularly prone to bias especially selection and
Hypertensive diabetic or diabetic with recall
 Inefficient for evaluation or rare exposure unless
tuberculosis
attributable risk percent is high
 Temporal relationship between exposure and
 Can examine multiple effects of a single exposure
outcome may be difficult to establish
 It minimizes bias in the ascertainment
 The groups may be confounded
 The temporal sequence between exposure and
-EXAMPLE:
outcome can be more clearly establish
 An expert panel of physicians and academicians
 It provides a strong evidence for possible cause
from the UP-PGH was asked by the DOH to review
and effect
and validate the 14 deaths that were allegedly
 Measures the relative risk
caused by adverse effects of Dengvaxia
 Variable of interest: death directly due to
-LIMITATIONS
vaccine administration
 Expensive
 Long follow up period needed
CASE
 Large number of subjects required
 EXPOSED: vaccinated individual who died due
 Difficult to obtain control if therapy is popular or
to adverse effects caused by vaccine
most people have been exposed
UNEXPOSED: vaccinated individuals who died
 Exposure may be related to some unknown factors
due to causes other than adverse effect
that is correlated with the outcome (confounding)
caused by the vaccine
 Blindness among subjects and assessors is difficult
to achieve
CONTROL
-EXAMPLE:
 EXPOSED: unvaccinated individuals who died
 Imagine the year is 2036, the Philippines is a non-
of the diseases/manifestations similar to the
parliamentary country Mocha Uson serving as the
adverse effects caused by the vaccine
Prime minister
 UNEXPOSED: unvaccinated individuals who
 Incidence of severe adverse effects to Dengvaxia
died due to other causes
among adults aged 30-45 years living in a rural or
urban area who were vaccinated in 2016
 Variables of interest/exposure: type of residence

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