Nutritional epidemiology

(CHS 269)

Lecture NO (2)

Studies in nutritional
epidemiology
•I) Observational
•2) Interventional (Experimental)
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 Observational )1(
• A) Descriptive Epidemiologic studies:
• 1- Case Report
• 2- Case series report
• 3-Correlation study (Ecological study)
• 4- Cross sectional study (prevalence
studies)

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 Observational (cont)
• B) Analytical Epidemiological studies
• Case control Study
• Cohort Studies
– i) Prospective cohort
– ii) Retrospective Cohort study

(2) Interventional (Experimental)

Randomized controlled trials

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I. Ecologic (correlational) Studies
• Compare rates of exposures and diseases in
different populations using aggregate data not
individual data.
• Usually conducted in the early stages of the
investigation of a diet-disease relationship.
• Used for a preliminary evaluation of a new
hypothesis to determine whether more extensive
and costly investigations are warranted.
– Because they are relatively quick and inexpensive

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I. Ecologic (correlational) Studies
• Examples:
–Very strong positive correlations were found
between meat and fat consumption and the rates
of breast and colon cancer in various countries.

• Example, by the late 1930s, it was recognized that the use of

water supplies with high fluoride concentrations led to mottling of
tooth enamel.
• Dentists observed that people with mottled teeth had low rates of
dental caries and they hypothesized that fluoride might prevent
caries.
• The US Public Health Service tested this hypothesis by conducting
an ecological study.

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 • Researchers surveyed the dental health of children in 13
cities where the fluoride concentration in the water supply
varied considerably.
• The results, reported in 1942, indicated that dental caries
decreased with increasing fluoride content of water.
• A fluoride level of 1 ppm appeared to be optimal;
• associated with a reduction in caries without an unsightly degree
of mottling.
• These ecological findings set the stage for later experimental
studies that established the benefit of adjusting the fluoride
content of drinking water supplies to one part per million.

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I. Ecologic (correlational) Studies
• Advantages of ecological studies
1. may be the only way to test a hypothesis
• Data on a particular exposure or outcome may be
available only for communities, not for individuals.
• For example, it is generally not feasible to measure
individual exposure to nutrients or toxic substances in
drinking water.
2. The findings for groups of people may not be applicable to
individuals.
3. There are many potential determinants of disease
other than the dietary factor i.e.
• genetic predisposition,
• environmental factors
• lifestyle practices
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 Case-control studies

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• Measurement of association between exposure
and outcome
2. Odds ratios
• Example: Calculate the Odds ratio from the table:
Patients With Free from
High salt intake
hypertension hypertension
Exposed (Ee) 60 )a( 20 )b(
None Exposed (E0) 40 )c( 80 )d(
Total 100 )a+c( 100 )b+d(

• Odds ratio= (60X80) ÷ (20X40)= 6

• So, high salt intake individuals are six times at risk to have
hypertension than non high salt intake individuals.
• odds ratios greater than one indicate an increase in
risk and odds ratios less than one indicate a
decrease in risk.
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II. Case-control studies
• Advantages of case-control studies.
1. They can investigate a wide variety of potential risk
factors simultaneously,
•
2. Possibility to match subjects for factors that are not
currently under investigation.
• For example,
• in a case-control study of lung cancer (profoundly influenced by
cigarette smoking)
• could select controls with histories of smoking as similar as
possible to those of the cases
• so that attention could be focused on other factors such as diet.

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II. Case-control studies
• Disadvantages of case-control studies.
1. Require collecting information about the subjects' past
exposures
2. They are subject to several types of bias.
• Various types of bias
1. Selection bias
2. Information bias
3. Regression dilution bias

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II. Case-control studies
1. Selection bias
 Selecting cases and controls from different populations
 Selecting control from general population by dialing random chosen phone
numbers , SO, controls will not include people who do not have telephones.
Because people who lack telephones tend to be of low socioeconomic
status, and because socioeconomic status influences the risk of disease,
the absence of these people from the control group may bias the study's
findings.

2. Regression dilution bias

• when variability in a biological measurement leads to underestimation of
the association
– For example, blood cholesterol levels vary from day to day within a
single individual. SO, If cholesterol levels are measured on a single
occasion and then assessing the association between these levels
and the risk of heart disease, the association will be weaker than the
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true one
 Cohort studies
Prospective cohort
- The exposure may or may not
have occurred at the time of the
study but the disease definitely
didn't occur.
- It begins in the present and
continue in the future
- Time consuming.
- Expensive
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Retrospective study
- Both exposure and disease
have occurred and the
investigator has to make sure
that the exposure occurred
before the disease status.
- It begins in the past and
continue to the present
- Save time.
- Cheap.
1. Relative risk (RR)
Patients With Free from
High salt intake Total
hypertension hypertension

)a( )b( )a+b(

Exposed (Ee)
20 180 200
)c( )d( )c+d(
None Exposed (E0)
2 198 200

• From the table we can find that:

– incidence of hypertension among exposed (high salt
intake individuals) (Ie)
a/(a+b) x 100= 20/200 x100= 10%
– incidence of hypertension among non exposed (non high
salt intake individuals) (I0)
c/(c+d) x 100= 2/200 x100= 1%
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1. Relative risk (RR)

• From the table we can find that:

– RR= Incidence among exposed (Ie)/ Incidence among non
exposed (I0)
• Interpretation of relative risk (RR):
– If RR >1, so people exposed to a factor have an increased
risk of a disease.
– If RR <1, so, people exposed have a decreased risk of the
disease.
– If RR= 1, so there is no relation between the factor and the
disease.

– From this example; RR= 10/1

– SO, high salt intake individuals are ten times at greater risk
of developing hypertension than non high salt intake
15 individuals.
IV. Cross Sectional (Prevalence Studies)
• Individuals are observed at a single point in time to provide a snapshot
of the health status of the population.
• Some cross-sectional studies are surveys.
• Provide information about disease prevalence and factors associated
with this prevalence.
• Unlike ecologic studies, it is known whether the individuals with the
disease are those with the exposure.
– An example, a study linked calcium intake with blood pressure measurements in
healthy populations.
– Data collected indicated individuals with higher blood pressure were those with
lower intakes of calcium.

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IV.Cross Sectional (Prevalence Studies)
• Advantages of cross-sectional studies:
– People are contacted only once, so these studies are
relatively inexpensive and can be completed relatively
quickly.
• Disadvantages of Cross-sectional studies:
– Reveal nothing about temporal sequence of exposure
and disease.
•not known whether dietary exposure is a consequence of the
disease or a causal factor.
– Only measure disease prevalence, not incidence.

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V.Experimental Studies (Intervention trials)
• Subjects are randomly assigned to receive or not receive a
treatment.
• Ideally, the participants in a trial should not know their group
assignment; through:
– giving an identical-appearing but inactive placebo to
those who do not receive the active treatment
• After a period of time, those who received the treatment are
compared with those who did not, to see if their health
outcomes were different.
• Advantages of intervention trials
• Providing direct evidence of a cause-and-effect
relationship.

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V. Experimental Studies (Intervention trials)
• Disadvantages of intervention trials
1. Subjects cannot be blinded to some types of nutritional interventions.
2. Involvement of ethical considerations that do not apply to observational
studies.
3.Dietary factors may exert their effects over a prolonged period of time: For
example, in a trial designed to evaluate the effect of ß-carotene
supplementation on lung cancer risk in male smokers,
– subjects received ß-carotene or a placebo for an average of 6 years.
– Unexpectedly, who received ß-carotene showed a small increase in
lung cancer risk
4. Assess only one or two factors at a time
5. Compliance with the treatment diet decreases during an
extended trial

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• Confounding factors
• distort an association because they are associated with an
exposure or a disease.
• unequally distributed in the study groups and may give rise to
false associations.
• Can be avoided by analyzing data separately for subjects who
fall into different categories (strata).
– For example, epidemiologists analyze data separately for:
• men and women,
• smokers and nonsmokers
• different age groups.

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• Causality
• In the absence of intervention trials, the following
criteria are used to evaluate whether an association
between an exposure and an outcome is causal.
1. Strength of association
2. Consistency of association
3. Dose-response relationship
4. Temporal relation
5. Plausibility
6. Reversibility
7. Study design

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• Causality
1. Strength of association:
– The stronger the association between an exposure and
an outcome, the greater the likelihood that it is causal.
2. Consistency of association
– i.e. similar results have been shown in other studies.
– If the association is consistently observed in different
populations and under different circumstances
• suggests that an exposure (factor) may be causal.

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• Causality
3. Dose-response relationship:
– If the intensity of a response increases with dose, the
relation may be causal.
4. Temporal relation:
– does the exposure (factor) precede the effect (disease)
– If the outcome occurs after the exposure, the
relationship is truly causal

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• Causality
5. Plausibility:
– i.e. is the association consistent with other knowledge.
• there is a known or hypothesized biological mechanism by
which the exposure is likely to alter the risk of a disease.
6. Reversibility:
– does the removal of a possible cause lead to reduction
of the disease risk?
7. Study design:
– The stronger the study design the evidence based on,
the greater the likelihood the relation is causal

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 Let's carry out an epidemiological study

• After attending a family dinner offering a meal

composed of grilled chicken, rice, mashed potato
and ice cream, 9 family members of attendance
developed gastroenteritis. All attainders were
interviewed. Use the data in the summary case
histories to determine the food item most likely to
have caused this outbreak

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 Food item State of Health
mashed grilled Case No.
Ice Cream Rice Well ill
potato chicken
√ √ √ √ √ 1
√ √ √ √ √ 2
√ √ √ √ 3
√ √ √ √ 4
√ √ √ √ 5
√ √ √ √ √ 6
√ √ √ √ 7
√ √ √ √ 8
√ √ 9
√ √ √ 10
√ √ √ 11
√ √ 12
√ √ 13
√ √ √ 14
√ √ √ √ √ 15
√ √ √ √ √ 16
 Answer
Food item Those who ate Those who did not eat
RR
Incidenc e
rate
1/Incidenc
ill well total Incidenc e ill well total Incidenc e
e rate 2
rate 1 rate 2
(ill/total*100 (ill/total*100
) )

Chicken 8 4 12 66.6% 1 3 4 25% 2.7

Rice 7 5 12 58.3% 2 2 4 50% 1.1

Mashed 5 5 10 50% 4 2 6 66.6% 0.7

poptatoes

Ice cream 8 2 10 80% 1 5 6 16.6 4.8

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