Study Design:
Descriptive studies
Prof. Dr. Md. Shahjahan
LESSON OBJECTIVES
• Overview of epidemiological study designs
• Hierarchy of study design
• Basic differences between Observational and Interventional
studies
• How to select the study design?
• Descriptive study designs
Case report
Case series
Cross sectional study
WHAT IS STUDY DESIGN?
Study design is a framework, or set of methods and procedures used to collect
and analyze data on variables specified for a particular research problem
Research design is
• the contextual structure within which research is
conducted
• it constitutes the blue print for the –
data collection
measurement
and data analysis
OVERVIEW OF EPIDEMIOLOGICAL STUDY DESIGN
Exploratory
Descriptiv
Non- Case-control
e
Interventional
Analytical /
Comparative
Cohort
Study
Design
RCT
Intervention
al Quasi-
Experimental
Field Trial
Clinical
Trial
Designs in Epidemiological
Research
Type of study Alternate name Unit of study
A) Observational studies
Descriptive studies
Cross- Prevalence Individuals
sectional
Incidence Individuals
Longitudinal
Analytical studies
Ecological Correlational Populations
Case-Control Case-Reference Individuals
Cohort Follow-up/ Individuals
B) Intervention Longitudinal
Studies
Experimental study Clinical Trial Patients
Quasi-experimental study Community intervention Healthy/Sick persons
studies Communities
OBSERVATIONAL/ NON INTERVENTIONAL
STUDY
Researcher explore, describes
and analyze but does not
intervene
Study based on the investigator
observing real-life situation and
drawing inferences from this
Key Characteristics : No manipulation
Potential for biases and
confounding
WHY OBSERVATIONAL STUDY?
• For some situations, it is more realistic to explore phenomena in
more natural manner.
Example : Effect of democracy on health: ecological study
[BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7480.1421
(Published 16 December 2004)Cite this as: BMJ 2004;329:1421]
Non-experimental research is often needed to scope out the
experimental one
INTERVENTIONAL /EXPERIMENTAL
STUDIES
Researchers introduce an intervention and
study the effects
Experimental studies are usually
randomized, that means the subjects are
grouped by chance
DECIDING WHICH ONE TO USE
The investigator observes the Observational study
events without altering them
NO Example: Prevalence of smoking among the
adult males in slums
Decision # 1
Alter the events under study?
Example: Impact of health education
Yes on cessation of smoking among the males In slum
The investigator applies an intervention,
& observes the effect on the outcome
Experimental study
EXPLORATORY STUDY
It is a small scale study of relatively short duration carried out when
little is known about a problem or situation
Goal : is to formulate problems, clarify concepts, and form
hypotheses
Exploration can begin with a literature search, a focus group
discussion, or case studies
DESCRIPTIVE STUDY
• Involves the systematic collection and presentation of data to
give a clear picture about a particular situation or problem.
• Describes Time, Place & Person distribution
• Formulate hypothesis
CONTD..
• Describing something with data (as opposed to showing a cause-effect
relationship)
• Example: Creating a segment profile (age, income, education levels etc.)
• Description goals must be clear at the outset unlike exploratory research
• No “manipulations”
• Cannot prove causality
CONTD…
Descriptive research provides answers to the questions of:
Who
What
Where
When
Which
Cannot commonly answer the question ‘Why’ and ‘How’? conclusively
DESCRIPTIVE SURVEY CONSISTS OF FOUR
MAJOR STAGES
Selecting an appropriate sample
Planning and developing instrumentation
Administering the instrument and data collection
Analyzing the findings
UNIVARIATE DESCRIPTIVE STUDIES
Could focus on one or more variables undertaken to describe the frequency
of occurrence of a behavior or condition or each variable rather than
relationships between or among them
Types:
• Prevalence studies
• Incidence studies
INCIDENCE AND PREVALENCE
Incidence:
Number of new cases of disease occurring over a specified period
of time
May be expressed per a known population size, rate of occurrence of
an event
Prevalence:
Number of cases of disease occurring within a population at any one
given point in time 16
CONTD…
Prevalence and incidence are
epidemiological measures showing
information about disease in the
population
This allows for evaluation of how often
and in which people diseases occur,
and planning for allocation of resources
for the future
INCIDENCE
• Incidence is the total number of new cases in a given period of time.
• Incidence= Number of new cases x 100
Population at
risk
• For example, if one hundred sow farms were followed for a year, and during
this time 10 sow farms broke with a disease, then the incidence risk for that
disease was 0.1 or 10%
PREVALENCE
Prevalence is total no of existing cases (old +
new)
In a defined population at a particular point in
time or specified period
Prevalence = Total no of cases at the given
point of time / estimated population at time X
100
In epidemiology, prevalence rates are generally found in
the following: -
Cross-sectional studies
Disease register studies
CASE REPORT
Report of a single individual or a group of individuals with the same diagnosis,
an important interface between clinical medicine & epidemiology.
Case reports contain a detailed report of the diagnosis, treatment, and
follow-up of an individual patient
Also some demographic information about the patient (for example, age,
gender, ethnic origin etc.)
CONTD…
Case reports usually describe an unusual or novel occurrence and as such,
remain one of the cornerstones of medical progress and provide many new ideas
in medicine
Example :
First confirmed case of COVID-19 infection in India: A
case report
COVID-19 vaginal delivery – A case report
15 April 2020, https://doi.org/10.1111/ajo.13173
Primary hypothyroidism presenting as ovarian tumor and
precocious puberty in a prepubertal girl
https://doi.org/10.1080/09513590600819032
CASE SERIES
Detailed presentation of a handful of cases, generally report a new or unique
finding
e.g. previous undescribed disease
e.g. unexpected link between diseases
e.g. unexpected new therapeutic effect
e.g. adverse events
Case reports are in many ways “sentinel events” which can lead to testable
hypotheses
CROSS SECTIONAL STUDIES
• Investigator measures the outcome
and the exposures in the study
participants at the same time
• A sample of persons from a
population is enrolled and their
exposures and health outcomes are
measured simultaneously
CONTD…
• Unlike longitudinal studies, cross-sectional studies are used to describe what
is happening at the present moment
• This type of research is frequently used to determine the prevailing
characteristics in a population at a certain point in time
• Can assess whether an association exists between an exposure and an
outcome at an individual level
CONTD…
A cross-sectional study or survey provides a snapshot of the health of a
population, so it assesses prevalence rather than incidence.
As a result, it is not as useful as a cohort or case-control study for analytic
epidemiology
Cross sectional studies are some of the first studies completed because of ease
and low cost time
ANALYTIC STUDY
• Analytic study attempts to establish causes or risk-factors for certain
problems
• It is done by comparing two or more groups
• Estimates risk of exposure on outcome
• Test hypothesis
DESCRIPTIVE VS ANALYTIC STUDY
• Describes the • Describes the determinants
distribution of problem of the problem
• No comparison group • Have comparison group
• No attempt to analyze • Cause – effect relationship is
cause-effect relationship analyzed
• Formulate hypothesis • Testing of hypothesis is done
CONTD….
Each subject is examined Cross-sectional study
on only one occasion
NO Example: Prevalence of smoking
among the adult males in slums
For observational studies
Decision # 2
Make measurements on more
than one occasion?
Example: Effect of smoking among the
Adult males in a slum
Yes
Each subject is followed over
A period of time
Longitudinal study
CROSS -SECTIONAL VS LONGITUDINAL
STUDY
Cross-sectional study Longitudinal study
Simplest form of An observational study
observational study Observation are
A single observation of a repeated in the same
cross-section of population over
population at one point in prolonged period of time
time is done by follow-up
examinations
Useful for chronic disease Useful for both chronic
CONTD….
Cross-sectional Longitudinal study
study
Also known as prevalence
Also known as Incidence
study study
Brings out distribution of Identifies the determinants of
disease in the population the disease
Usually less time is It is time consuming
needed More expensive
Less expensive Gives good information about
Gives little information natural history of disease
about natural history of