Study Design-1

Dr. Noushin Fahimfar

MD, MPH, PhD of Epidemiology

Tehran University of Medical Sciences

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Study designs

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Levels of Evidence and Study Designs

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 Descriptive Studies
• Descriptive epidemiology never tries to answer the
‘why?’ question.

• Its aim is to present existing data on the cases as clearly

and comprehensively as possible, using tables, diagrams,
graphs or maps.

• The descriptive work always starts with a list of cases

which is usually entered into a spreadsheet program, or
into one of the programs especially designed for
epidemiological analysis.
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 Descriptive Studies
• The first analysis is done by grouping the cases
according to the following:
• Time
• Place
• Person

• When
• Where
• Who

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 Table or Diagram?
• The choice to show the data as a table or as a figure is
very much a personal one.
• To some extent it depends on where and how the
descriptive data will be presented: in a lecture a diagram
is almost always preferable. Time will be too short for
the audience to study a table, and the main points one
wants to convey will come across much faster with a
clear graph.
• In a publication, a table is often better. It can contain
more exact detail, and especially if the reader wants to
compare your findings to her own, it can be very
frustrating to have to use a ruler to try to get the exact
values of something presented in a graph.
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• The choice between a line graph and a bar graph is also to
some extent personal.

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• Surveillance data over time are often shown as a line,
especially if the number of cases is high.
• Epidemic curves are rarely drawn as lines

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Try to never use 3D graphs! They add no information at
all, but only complexity and can be misleading.

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 Case Report/Case Series
• Some medical research questions is through careful
observations by physicians and other health care
providers of what they see during their clinical
practice.
• Case report
Individual-level observations (describing a particular
clinical phenomenon in a single patient)

• Case series
Describing more than one patient with similar problems
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• A case report is a detailed description of disease
occurrence in a single person. Unusual features of the
case may suggest a new hypothesis about the causes or
mechanisms of disease.

• Example: Acquired Immunodeficiency in an Infant;

Possible Transmission by Means of Blood Products

• Blood donation in an infant born with Rh incompatibility,

resulted in unusual recurrent infections with opportunistic
agents such as Candida with low T cell count. One of the blood
donors was found to have died of AIDS. This led the
investigators to hypothesize that AIDS could be transmitted by
blood transfusion
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• A case series is a report on the characteristics of a
group of subjects who all have a particular disease or
condition. Common features among the group may
suggest hypotheses about disease causation. Note that
the "series" may be small or it may be large (hundreds
or thousands of "cases").

• Example: Discovery of HIV in the United States

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The main objectives of case report/case series
• The main objective of case reports and case series is to
provide a comprehensive and detailed description of
the case(s) under observation.

• This allows other physicians to identify and potentially

report similar cases from their practice, especially
when they share geographic or specific clinical
characteristics.

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• Advantages:
 Key hypothesis-generating tools,
 Simple,
 Inexpensive,
 Easy to conduct in the course of busy clinical
settings.

• Disadvantages:
 The lack of a comparison group
 The limited external validity (generalizability)
 The biased selection of cases (all identified in
clinical practice).
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 Ecological study

 The first approach in determining whether an

association exists may be a study of group
characteristics, the so-called ecologic studies.
 Ecological study

 An ecological study is a study in which at least one

variable is measured at the group level.

 An ecological study is appropriate for initial investigation

of causal hypothesis.

 Usually takes advantage of pre-existing data collected for

other purposes- an efficient and economical study design.

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There are three types of ecological variables:
1. Aggregate Variables
• A summary or composite measure derived from values collected from
individuals.
• Aggregate variables can measure exposure (e.g., mean blood pressure)
or outcome (rate of disease) variables.

2. Environmental Variables
• A measure of the physical characteristics of the environment (a
geographic location) in which people reside, work, recreate or attend
school.

3. Global Variables
•A measure of the attributes of groups, organizations, or places for which
there is no analogue at the individual level.
 Why do an ecologic study?
HYPOTHESIS BUILDING!

• The data is easy to obtain, no follow up or individual contact is

needed.
• An ecologic study can suggest avenues of research that may
cast light on an etiologic relationship between exposure and
disease
HOWEVER

An ecologic study does not itself demonstrate that a causal

relationship exists
- Consider Switzerland, for example, which has the highest number of Nobel
laureates per capita and the highest average consumption of chocolate.

- The problem is that we do not know whether the individuals who won Nobel Prize
in that country actually had a high chocolate intake
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• Main limitation and weakness?

• Ecologic Fallacy

• What is “Ecologic Fallacy”?

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International comparisons of prostate cancer mortality rates
with dietary practices

Do the data support

the hypothesis that
increased sugar
consumption is
associated with
increased prostate
cancer mortality?

Do the data determine that sugar consumption causes prostate cancer death?
 Association between fat consumption and breast cancer by
countries USA
250
Switzerland
Incidence Ratio per 100,000 Women

Canada

200 Italy Germany

Israel UK Denmark
France
Sweden
New Zealand
Australia
150 Norway
Finland
Yugoslavia Spain

100 Poland
Romania
Hong Kong Hungary

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Japan

0 600 800 1000 1200 1400 1600

Prentice RL, Kakar F, Hursting S, et al: Aspects of Per Capita Supply of Fat Calories
the rationale for the Women’s Health Trial. J Natl
Cancer Inst 80:802-814, 1988.)
Is there a relationship between breast cancer
incidence and dietary fat consumption by country?

From the graph , we see that as average dietary fat

consumption increases, breast cancer incidence
increases.
What is wrong with this data?
The problem is: the ecologic fallacy!

High positive correlation between cancer rates and fat

calories consumption. Cancer actually might occur in
the community who had used less fat calories.
Prentice et al. J Natl Cancer Institute 1988 80:802-814
QUESTIONS?

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