BIOSTAT: BIOSTATISTICS & EPIDEMIOLOGY

Lecture 14: Epidemiologic Study Designs

2nd Year|1st Semester| A.Y 2022 – 2023

EPIDEMIOLOGIC STUDY DESIGNS Strength of Evidence for Causality

CLASSIFICATION OF STUDY DESIGNS

 Analytic vs. Descriptive

 Observational vs. Experimental
 Prospective vs. Retrospective
 Longitudinal vs. Cross-sectional
4 GOALS OF EPIDEMIOLOGICAL
RESEARCH
1. Describe the health status of population
2. Explain the etiology of diseases by
determining factors that cause specific
diseases
3. Predict the number of disease occurrences Descriptive Studies
and the distribution of health status
4. Control distribution of disease in the Refers to the study of amount or occurrence of
population by prevention disease, its distribution within the population for
the purpose of identifying non-random variation in
PRIMARY TYPE OF STUDIES disease occurrence
DESCRIPTIVE ANALYTICAL - 1st step in risk factor determination
Describes Explains
- data lead to formulation of research
More exploratory More explanatory
Profiles characteristics Analyzes why group hypothesis
of groups has characteristics Sources Of Data: routinely collected
Focuses on “what” Focuses on “why”
Assumes no hypothesis Assumes hypothesis Examples: census, vital registries, clinical
No comparison between Comparisons between records, employment health examination
groups over time groups over time
TYPES OF DESCRIPTIVE STUDIES
A. Ecologic Study
- correlational or aggregate studies
- measures the characteristics that represent
entire population
- comparison of groups rather than individuals
describes disease in relation to a factor of
interest

There are two groups of research designs:

Examples:
(a) Observational or Descriptive studies -
- Mortality from CHD & per capita cigarette
Descriptive studies aims to determine the nature,
sales
amount, and distribution of disease in a population
- Mortality from CHD & per capita alcohol
(b) Analytic studies - Analytic studies aims to consumption
test a hypothesis about the relationship between
two variables.
Characteristics:
- unit of observation & analysis: group
 BIOSTAT: BIOSTATISTICS & EPIDEMIOLOGY
Lecture 14: Epidemiologic Study Designs
2nd Year|1st Semester| A.Y 2022 – 2023
- represent average exposure and disease
levels rather than actual individual levels
Sources Of Data: population registries, census,
vital registries, large surveys
- may use prevalence, incidence or mortality
data
Advantages:
- low cost and convenience
- overcome measurement limitations of
individual-level studies
- overcome design limitations of individual-
level studies
- interest in ecological effects
- simplicity of analysis and presentation
Limitations:
- cannot link exposure with disease at the
individual level
- lack of ability to control for effects of
potential confounding factors
- correlational data represent average exposure
levels rather than actual individual values
Methods Of Analysis
Graphical: scatter-plot
Computation Of:
- correlational coefficient (r)
- coefficient of determination
- Linear regression analysis
- Y = a + bX
B. Case Report:
- document unusual medical occurrences
- represents first clues in the identification of
new disease or adverse effects of exposures
- new syndromes or variants of known disease
C. Case Series
- collection of individual reports
- early means to identify the presence of an
epidemic
- investigation of affected individuals can lead
to hypothesis generation:
 identification of the disease
 identification of specific risk factors
Limitations of Case report and Case studies
- cannot be used to test for the presence of a
valid statistical decision
- based on experience of a single person/
group of persons only
- interpretability of information is severely
limited by lack of appropriate comparison
group
-
ANALYTIC STUDIES
A. Cross-Sectional Studies
- provides information about the frequency
and characteristics of the disease by
furnishing a “snapshot” of the health
experience of the population at a specified
time
- provides information on the prevalence of
disease or other health outcomes
- monitor changes in population over time
- make inference about risk of developing
disease
- determine association between coexisting
variables
- Exposure (E) and Outcome/Disease (D)
variables are measured at one point in time
or over a very short period of time
 BIOSTAT: BIOSTATISTICS & EPIDEMIOLOGY
Lecture 14: Epidemiologic Study Designs
2nd Year|1st Semester| A.Y 2022 – 2023
Prevalence study/ survey: use to estimate
prevalence
Difference from descriptive type: presence of
comparison groups
Analysis: Measures of disease occurrence
- prevalence proportion
- disease/ prevalence odds
Analysis: Measures of association
- prevalence difference
- prevalence ratio
- odds ratio
Analysis: Prevalence Proportion
Analysis: Prevalence Difference
- PD = PE+ - PE-
- Interpretation: Prevalence Difference
Analysis: Prevalence Ratio
- PR = PE+ / PE- =
- Interpretation: Prevalence Ratio
PR interpretation
1.0 is the null value of PR
- suggest that exposure is not associated with
disease
if PR is > 1
- exposure is positively/ directly associated
with the disease
if PR is < 1
- exposure is negatively/ indirectly associated
with the disease
Advantages:
- resource-efficient
- does not suffer from lost to follow-up
Limitations:
- difficult to establish the temporal
relationship between study variables
- unable to establish causality
- lacks information on past exposure
- may miss disease of short duration or with
periods of remission
B. Case - Control Study
Steps:
1. Define and select cases
Establish objective criteria
- diagnostic criteria for the disease
- eligibility criteria
- may be problematic if diagnostic procedure
is expensive
2. Definition and selection of controls
Select control - get controls from the same source
population as the case
Source: hospital, genera population, special
groups
Methods: random sampling or paired sampling
(matched)
3. Ascertainment of exposure - operational
definition of exposure variable
Sources: subjects or medical records
 BIOSTAT: BIOSTATISTICS & EPIDEMIOLOGY
Lecture 14: Epidemiologic Study Designs
2nd Year|1st Semester| A.Y 2022 – 2023

Methods of data collection: same for the 2
groups
Reference point should be identified: basis on
which as individual should be considered exposed
4. Analysis: Odds ratio (OR)
Case-control study – a study that allows the
comparison of the attributes of a group of cases
(subjects with the outcome of interest) to a group
of controls (subjects without the outcome of
interest).
Cross-sectional study – a study design that
investigates the relationship between existing
exposure characteristics and existing outcome
information in a group of subjects.
Incident cases – cases that are enrolled as the
outcome of interest occurs.

Interpretation: Odds ratio 1: no association

>1: association - risk factor
<1: association - protective factor

Advantages:
- quick and inexpensive
- suited to disease with long latency
- optimal for rare disease
- can examine multiple etiologic factors for a
single disease

Limitations:
- inefficient for rare exposure
- cannot generate incidence of disease
- difficult to establish temporal sequence
- prone to bias

TERMINOLOGIES
Descriptive study - a study intended to determine
the distribution of the disease
Analytic study - a study that tests one or more
hypotheses about the relationship between risk
factors and disease, generally looking for
causation