STUDY DESIGNS

Epidemiologic studies broadly

classified as:

Observational - Non-Interventional

Experimental - Interventional

OBSERVATIONAL:
Here nature allowed to take its
course. Changes and differences
in one variable are studied in
relation to changes and
differences in another.
Investigator DOES NOT intervene.
- (e.g. Smoking v/s lung cancer:
Investigator does not decide who
smokes and who must not).

EXPERIMENTAL:

Investigator deliberately
introduces change in one variable
and measures effect of this on
outcome.
- These have ethical problems in
humans as well as costs involved.
- Therefore most studies are
OBSERVATIONAL.

Observational studies

These range from

- Relatively weak studies .e.g
Case reports and Ecological
studies
to
- Strong studies e.g. Cohort and
Case-Control studies.

Observational studies
cont..:

Observational studies are

either:
- Descriptive
- Analytical

Descriptive studies:

Weakest epidemiological design.

Investigator merely describes

health status of pop. or
characteristics of a number of
patients by time, place and
person.

It offers limited information about

group of patients, their clinical
characteristics and outcomes.

Descriptive Studies cont:

These studies are weak because

they make no attempt to link cause
and effect thus no causal
association can be determined.

However, are often first step to

well designed epidemiological
study.

Can define good hypothesis to be

DESCRIPTIVE STUDIES cont

Description by
- Person - stating what pop. and
sub pop. do or do not
develop disease.
- Place Its geographical location
- Time - How does frequency of
disease vary with time.

DESCRIPTIVE STUDIES cont

Indices of person include demographic

e.g.:
Sex, age, life style e.g. alcohol use and
medicines.
Characteristics of place e.g.:
Variation between regions, or countries

Time characteristics e.g.:

- Season variation, Frequency with time.

DESCRIPTIVE STUDIES cont:

Examples of Descriptive studies:

- Case reports and Case series.

Case reports

Considers single or grp of patients

similar diagnoses.
-

with

- Clinician identifies unusual feature of

disease
and formulates a hypothesis.
- They represent important interface
between clinical medicine and epidemiology.

DESCRIPTIVE STUDIES
cont:

Case reports and series are among

most published in journals (Over 1/3
of articles).

Case series are collection of

individual case reports which may
occur within a fairly short time
period.

Case-Series and Case Reports:

This study type has important

historical place:
- Was used as early means to
identify presence or beginning of
epidemic.
- Even now, in routine
surveillance, case reports can
suggest new disease or epidemic.

Case-Series and Case Reports:

In investigating affected
individuals they can lead to
hypothesis formulation.

An analytic study, may then be

conducted to compare the
experiences of individuals with
disease to identify possible causal
factors

Case-Series and Case Reports

cont:
e.g. Early epidemiology of AIDS:
Between October 1980 and May
1981, 5 cases of previously healthy
homosexuals in U.S. had pneumocystis Carinii pneumonia (PCP)

PCP was known to occur in older

cancer patients with
immunosuppression due to
chemotherapy.

Case-Series and Case Reports

cont:
1981 young homosexuals seen with
Karposis Sarcoma.
- Again this was known mostly common
in elderly men and women equally.
- Thus hypothesis was formulated.
While case reports and case series are
very useful for hypothesis formulation;
- They cant be used to test valid
statistical association.

Case-Series and Case Reports

cont:

Limitations include fact that:

- Based on experience of one person.
Presence of any risk factors may be coincidental.
- Frequently not large enough to permit
quantification of frequency of an
exposure.
- Interpretation limited for lack of
appropriate control group.

OBSERVATIONAL STUDY:
(analytical)
CORRELATIONAL
(ECOLOGICAL) STUDIES

Ecological (Correlational):

Are also weak designs.

- Units of study are populations
other than individuals.
- Useful also in generating
hypotheses but no causal
inference can be drawn. *An
apparent ecological link may not
be a true link.
- May be confounded by several

Ecological (Correlational).:
Investigator measures characteristic of
entire population to describe disease in
relation to age, sex etc.
E.g. Pap Smears Correlation with mortality
from cancer of the Cervix.
- For example the % in Cancer Cervix in 2
periods.
- 1950-1954 - Time pap started to be
used widely
- 1960-1964 - Time notable in mortality
could have started

Ecological (Correlational)..:

% of women with pap screening

was noted in different states.
States with highest % of women
screened had strong and
significant correlation and had
largest % in mortality.
Conversely those with lowest %
showed significant smallest % in
mortality.

ECOLOGICAL (CORRELATIONAL):
Example raises question
(hypothesis) that:
Screening mortality from Ca.
Cervix.
Hypothesis cant be tested
(answered) with this data since:
a) Dont know whether women
screened are those who
experienced lower mortality i.e.

ECOLOGICAL (CORRELATIONAL):
b) Cant control for potential confounding
factors.
E.g.
-In Study of per capita average daily intake
of pork in relation to Breast Cancer.
- A strong +ve Correl. between death from
Ca. breast and pork eating was noted.
(Hypothesis).
- However pork eating may be marker to
other factors e.g.
-fat in body)
- vegetable eating) - These risk of
breast Cancer.

Ecological (Correlational):
Cant separate confounders using
correlational data.
- More dramatic illustration of this limitation is:
-Very strong +ve correlation between per
capita number of colour TV sets and CHD
mortality in different nations.
Hypothesis is there is association between
colour TVs and CHD mortality.
- However colour TVs are related with other
lifestyles and these risk of CHD e.g.
smoking, cholesterol, inactivity.

Ecological (Correlational):
- Again absence of correlation does not
mean absence of valid statistical
associations.
E.g. In early 70s use of oral
contraceptives in USA.
At same time mortality rates from CHD
among all childbearing women 30%.
-This information does not support a +ve
association between use of Oral
Contraceptives and risk of fatal CHD.

ECOLOGICAL (CORRELATIONAL):

Later, Cohort and Case-Control

studies have shown a two fold in
risk of fatal CHD in women using
OCs than those who dont.
This is difficult to get or perceive
by correlational or ecological data.

ECOLOGICAL (CORRELATIONAL):

Correlation data provides average

exposure levels rather than actual
individual levels.
*So an overall +ve or ve linear
association may be shown but may
be masking more complicated
relations between exposure and
disease.

Ecological (Correlational).:
E.g. In various countries the per capita alcohol
consumption showed a striking simple
inverse linear relationship with CHD
mortality.
This meant that: Countries with per capita alcohol
consumption had CHD mortality risk

Countries with per capita alcohol

consumption had CHD mortality.

ECOLOGICAL (CORRELATIONAL):

Later it was shown that the

relationship is not this simple.
Actually the association is best
represented by a J-shaped curve.
Those consuming largest amounts (C)
have highest risk.
Those drinking small to moderate
amounts (B) have lowest risk.

CHD Rate

A
B

Alcohol Consumption

Ecological (Correlational):

Those who dont drink have slightly (A)

higher risk than (B).
Such non-linear relationship cannot be
identified easily from correlation
studies in which:
Exposure represents an average
consumption for population rather than
the actual consumption patterns of
individuals.

OBSERVATIONAL STUDIES
(DESCRIPTIVE)
CROSS-SECTIONAL STUDIES

CROSS-SECTIONAL Studies
Also Descriptive studies sometimes
called prevalence surveys.
- Here exposure and disease are
assessed simultaneously in individuals
of well defined pop.
(Diarrhoea/Bacterial infection).
Its like a specific window e.g. calendar
year, in which community wide survey
is conducted

*OR:

Cross-sectional studies.:

Fixed point in the course of events that

varies in real time from person to
person e.g.

Pre-employment exam
Pre-school entrance exam

These provide information about:

- Frequency and Characteristic of disease
e.g. affects men only by giving a
snapshot of health experience of pop.

CROSS-SECTIONAL Studies.:

Cross-sectional studies also useful for

disease prevalence etc in certain
occupations.
But since exposure and disease are
assessed at a single point in time, one
CANNOT determine whether exposure
preceded or resulted from the disease.

Hypothetical Situation
OCCUPATIONAL EXPOSURE &
DISEASE PREVALENCE
MEASURED BY X-SECTIONAL
SURVEY:

Occupational exposure & Disease

prevalence by X-sectional survey:

JOB A has known hazardous exposure.

JOB B doesnt
- If conduct X-Sectional study at X, then more in
A have respiratory disease than in B.

Ratio A:B= 4.0

20:5

- If conduct study at Y, 15 will be in (B) and 10

in (A).
Thus prevalence will be:

A = 10 and
90

B=15
110

Occupational exposure & Disease prevalence by

X-sectional survey:

Ratio A:B = 0.8

At Y greater prevalence in B not cause
Job is more hazardous but cause 10
from A chose to change to less
hazardous.
- So being in B at point Y for those with
respiratory symptom is:

The effect of the symptoms, not the cause.

This type of chicken/egg dilemma is
common in virtually all X-sectional studies.

X-Sectional Studies Cont:

Another example:
- Investigators compared prevalence
rates of CHD among white farmers
between;

a) Those who did their own labor.

V/S
b) Those who did not do their own labor.

X Sectional studies..:

Prevalence rates of CHD among (b)

were X5 higher than those in (a) i.e.
157.2 versus 33.3/1000. (Even after
adjusting for age).

- It is not possible to know whether it is

truly protective or those with CHD are
likely to reduce their physical labor.

X-Sectional studies cont.:

X-sectional studies consider prevalence
rather than incidence.
- They reflect determinants of survival and
aetiology
E.g.
- A study shows low prevalence of CHD among
blacks than whites.
- Since there is nothing to show CHD develops
less in blacks than whites.

X-Sectional studies cont.:

It could be :

True that whites develop more CHD or

Blacks have higher rates of CHD but die at
higher rates.

So X-sectional data can not distinguish

between the two.

X-Sectional studies cont.:

In most instances X-sectional data is

used to describe characteristic of
individuals with disease and formulate
hypotheses, but not test them.