Study design

Objectives: ِ
• To know the different types and varieties of
designs that are commonly used in medical
researches.

• To know the characteristics, advantages and

limitations of each type in order to know how to
choose a proper design that helps conduct a
strong, efficient and valid study that is neat of
errors and bias.
 Types of studies
A study is an organized, systematic, scientific search
for the truth.

Study design:
Is the main structure of the study that determines
it’s approach, plan, and steps of conduction and
implementation to reach an inference.

- Quantitative
- Qualitative
We design a study according to:

• Objective(s) of the study

• Nature of the research question

• Our resources

• The inference we aim or expect to reach

We have two main types of epidemiologic studies:

1. Descriptive

II. Analytic
 I. Descriptive studies

Characterize the occurrence of disease in terms of:

person-place-time, or host-agent-environment,
characterizes exposure and susceptibility state.

It enables us to develop (formulate) hypotheses

about the disease pattern and also to identify the
high risk population.
1. Case report: describes clinical observations,
interesting or unusual variation of a disease.

Advantages:
- Easy, simple, quick, inexpensive.
- Calls attention to unexpected findings.

Disadvantages: cannot be generalized (single

case and not population based).
2. Case series:
Refers to a group of similar cases which may
enable us to discern a clinical pattern to identify
characteristics common to the cases.
Advantages:
- Easy, simple, quick, and inexpensive.
- Recognition of a new disease or beginning of an
epidemic.
Disadvantages:
- Cannot be generalized (small sample size).
- Estimation of risk cannot be done (because
of lack of a control group).
3. Cross-sectional:
(prevalence study, photograph, snap shot, ….)
describe or identify health problems in the entire
population (or a sample of the population) at a
point in time or over a short period of time.

Advantages:
- Inexpensive & not time consuming.
- Measures the prevalence.
- Can study many variables at the same time.
Disadvantages:

- Risk cannot be measured.

- Chicken-egg dilemma; because the exposure

& disease are assessed at the same time.

- Selecting survival (usually in fatal disease).

- Bias: memory, recall, interviewer, loss of

accuracy of temporal relationship.
4. Ecologic (Correlation) studies
Measures that represent characteristics of entire
population are used to describe disease and to postulate
causal association.

Strengths: Cheap, quick and simple (generally make use of

secondary data).
Limitations:
• Can not link exposure-disease relationship at the individual level
• Uses average exposure levels rather than actual levels of exposure
• Inability to control for confounding factors
5. Biometry
6. Hospital-records study
7. Meta analysis

(Generally descriptive studies are used only

to suggest hypotheses & not to test them.)
II-Analytic-studies:
go beyond simply describing the distribution of
occurrence of diseases & attempt to analyze the
reasons for them (testing etiological hypotheses).
So hypotheses derived from descriptive studies may
be tested by analytic studies.

Factor & disease can be the dependent or

independent variable according to the approach of
the study.

It is of 2 types:
A- Observational:

In which we just observe (then analyze) what

is going on without interference

- Case control studies

- Cohort studies
 Case control
Exposed
Disease
Not exposed

Exposed No
Disease
Not exposed
[Link]-control:
in which subjects are selected on basis of
presence or absence of disease.
Advantages:
- Easy, quick, inexpensive & can support
(but not prove) casual hypotheses.
- Useful in rare diseases but not rare exposures.
- Odds ratio can be estimated from it.
Disadvantages:
- Cannot measure incidence or RR.
- Bias: selection, memory, and recall
 Cohort

Disease
Exposed
No Disease

Not Disease
exposed No Disease
2. Cohort study: a forward looking study
(movie picture) in which subjects are selected
on bases of presence or absence of exposure.
(The results are expressed in incidence).
Types:
- Retrospective cohort: investigate persons known to
have a disease before the time of the study, but the
problem is that we cannot know which precedes
which: the factor or the disease. (So RR cannot be
estimated). It is especially important in diseases with
long latency period.

Exposure out come * start of the study

- Prospective: (longitudinal, incidence or follow up,..):
study of persons free of the disease at the start of the
observation period (the most common type of cohort).

* Start of the study exposure outcome

- Historical prospective: similar to the prospective

but some of the persons have been already exposed
before the start of the study by a certain period & then
continue till reach the defined period of the study.

Exposure * Start of the study outcome

Advantages:
- Test hypotheses of casual relationship & give directly RR.

- Temporal sequence between exposure & disease can be

more clearly established.

- Confirm causes, and magnitude of risk can be quantified

more clearly because it gives us incidence rates.

- Particularly suited for assessing the effects of rare exposures.

Disadvantages:

- Time, efforts & money consuming.

- Problems of non-response or drop out (attrition).

- Not feasible for disease of low incidence because

non or very few persons in the sample may actually
manifest the disease.
B- Interventional: (randomized trial)

A high quality type of cohort studies in which the

investigator himself allocates the exposure, means we
don’t only observe but do interfere in the form of a
new element which could be a new drug, surgical
procedure, vaccine, test, or new method of diagnosis.

So it has the potential to provide a degree of

assurance about the validity of a result that is not
possible with any observational design option.
Types:

Therapeutic trial:
- Two different drugs or procedures.
- Drug & placebo
- Single drug (before & after Rx).

Preventive trial:
- Individuals (as in polio vaccine).
- Entire pop. (community trial) an in floride
fortification of water.
 Types
• Randomized controlled trials (clinical trials)
• Cluster randomized controlled trials
• Field trials
• Community trials
Unique problems:

- Ethical: we must be sure that it is not harmful, never

the less we must inform them about the aim of the
study & the possible complications, get their
acceptance & decide when to stop & when to proceed,
there must be sufficient doubt about the agent to be
tested to allow withholding it from half the subjects &
at the same time there must be sufficient belief in the
agents potential justify exposing the remaining half.
- Feasibility: should be considered before a belief gets
spread.
- Cost.
Other problems:

- Chance: managed by increase sample size &

randomization.

- Bias (subjectivity): treated by masking &

blinding (single, double & triple blinding)

- Confounders: by matching of all factors (or as

much as we can) except the factor under study
 Descriptive Case report
Case series
Cross sectional
Correlational
Study Design
Biometry

Analytic Hospital records

Case Control
observational
Interventional
Cohort

Clinical trial Retrospectiv Prospective

Randomize Community Field Historic
-Therapeutic e
d trial trial trial prospective
-Preventive
Q1.A researcher measures BMI and depression symptoms
for 800 adults during a single health survey conducted in
June 2025.
What is the study design?
A. Cohort
B. Case-control
C. Cross-sectional
D. RCT
Answer: C

[Link]-sectional studies are BEST for measuring:

A. Incidence
B. Prevalence
C. Cause and effect
D. Rare diseases
Answer: B
Q3.A study selects 150 patients with myocardial infarction and 150
controls without MI, then asks both groups about their past
smoking habits.
What is the study design?
A. RCT
B. Case-control
C. Cohort
D. Cross-sectional
Answer: B
Q4.A study follows 4,000 factory workers (exposed to chemicals)
and 4,000 office workers (not exposed) for 15 years to observe who
develops COPD.
What is the design?
A. Prospective cohort
B. Retrospective cohort
C. Case-control
D. Ecological
[Link] studies mainly calculate:
A. Odds Ratio
B. Prevalence Ratio
C. Relative Risk
D. Standardized Mortality Ratio
Answer: C

[Link] with hypertension are randomly assigned to Drug A

or Drug B and followed for 1 year.
What design is this?
A. Cohort
B. RCT
C. Case-control
D. Ecological
Answer: B
[Link] main advantage of RCTs compared with
observational studies is:
A. They require fewer participants
B. They eliminate all confounding
C. They provide strongest evidence for causality
D. They are less expensive
Answer: C

Q8.A study analyzes the relationship between average

national salt intake and national stroke rates.
What design is this?
A. Case-control
B. RCT
C. Ecological(correlation)
D. Cohort
Answer: C
THANK YOU