Clinical Epidemiology

Savitri Sayogo
2009

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 CLINICAL EPIDEMIOLOGY
Clinical epidemiology is the application of
epidemiological principles and methods to the
practice of clinical medicine

Clinical epidemiology is concerned with :

 Definitions of normality and abnormality

 Accuracy of diagnostic tests
 Natural history and prognosis
 Effectiveness of treatment and prevention.
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 CLINICAL EPIDEMIOLOGY
Clinical epidemiology is the science of making
predictions about individual patients by
counting clinical events in groups of similar
patients and using strong scientific methods to
ensure that the predictions are accurate.

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The purpose of clinical epidemiology is to
develop and apply methods of clinical
observation that will lead to valid conclusions
by avoiding being misled by systematic error
and the play of chance.

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The term clinical epidemiology is derived from
its two parent disciplines: clinical medicine and
epidemiology. It is clinical  because it seeks to
answer clinical questions and to guide clinical
decision making with the best available evidence.

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It is epidemiology because many of the methods
used to answer these questions have been
developed by epidemiologists and because the care
of individual patients of seen in the context of the
larger population of which the patient is a member.

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 THE RELATIONSHIP BETWEEN
EPIDEMIOLOGY + CLINICAL MEDICINE

Population Individuals

Studies /Assessments Diagnosis

Prevention Treatment
Evaluation Curing
Planning Caring

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 TABLE 1 Clincal Issues and Questions

Issue Question
Abnormality Is the patient sick or well ?

Diagnosis How accurate are tests used to diagnosed disease ?

Frequency How often does a disease occur ?

Risk What factors are associated with an increased risk of disease ?

Prognosis What are the consequences of having a disease ?

Treatment How does treatment change the course of diseasee ?

Prevention Does an intervention on well people keep disease from arising ?

Does early detection and treatment improve the course of disease ?

Cause What conditions lead to disease ? What are the origins of the
disease ?
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 DEFINITIONS OF NORMALITY
AND ABNORMALITY :

 Normal as common

 Abnormal as associated with disease

 Abnormal as treatable

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 BASIC PRINCIPLES

The purpose of clinical epidemiology is to

foster methods of clinical observation and
interpretation that lead to valid conclusions
and better patients care.

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 Variables
Things that vary and can be measured.

There are two mind kinds of variables. One is a

purported cause or predictor variable, sometimes
called the independent variable.

The other is the possible effect, sometimes called

the dependent variables.

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TABLE 2 Outcomes of Disease (the Five Ds)
Death A bad outcome if untimely

Disease A set of symptoms, physical signs, and laboratory abnormalities

Symptoms such as pain, nausea, dyspnea, itching, and tinnitus

Discomfort
Impaired ability to go about usual activities at home, work, or
Disability recreaction.

Dissatisfaction Emotional rection to disease and its care, such as sadness or

anger

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 Population and Samples
Populations are all people in a defined setting (such as
Jawa Timur) or with certain defined characteristics
(such as being age >65 years or having a thyroid
nodule).

A sample is a subset of people in the defined population.

The extent to which a sample represents its population,

and thus is a fair substitute for it, depends on how the
sample was selected.

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 Bias (Systematic Error)
 Bias is a process at any stage of inference
tending to produce results that depart
systematically from the true values.

 Any trend in the collection, analysis,

interpretation, publication, or review of data
that can lead to conclusions that are
systematically different from the truth

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 TABLE 3 Bias in Clinical Observation
Selection Bias Occurs when comparisons are made between groups of patients
that differ in determinants of outcome other than the one under
study.
Measurement Bias
Occurs when the methods of measurement are dissimilar among
groups of patients.
Confounding Bias
Occurs when two factors are associated (travel together) and the
effect of one is confused with or distorted by the effect of the
other.

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Confounding Bias can occur when one is
trying to find out whether a factor, such as a
behavior or drug exposure, is a cause of
disease if that factor is associated or travels
together  with another factor, which is itself
related to the outcome, that effect can be
confused with or distorred by the effect of the
other.

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MAIN FOLIC COLON
QUESTION ACID CANCER
S INTAKE PREVENTION
Age
Aspirin use
Physical
activity
Body mass
index
Cigarette
soking
Family history
Diet
Alcohol use

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Figure 1. POTENTIALLY CONFOUNDING FACTORS
 Figure 2.
Confounding : coffee drinking, cigarette smoking, and
coronary heart disease

EXPOSURE DISEASE

(coffee drinking) (heart disease)

CONFOUNDING
VARIABLE
(cigarette smoking)

WORLD HEALTH ORGANIZATION

Confounding occurs when a factor other than the one being studied is associated both with the disease and
the factor being studied. In this case the study indicates an association between coffee drinking and heart
disease. Cigarette smoking is a confounding variable because it is known that it causes heart disease and18in
addition it is associated with coffee drinking; those who drink lots of coffee on average smoke more than
those who drink little coffee.
 Chance
The divergence of an observation on a sample
from the true population value, due to chance
alone, is called rendom variation.

Even if selected without bias, may

misrepresent the situation in the population as
a whole because of chance.

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 Figure 3. Validity and reliability

Validity

High Low
Measured values Measured values

High
True values True values
Relibiality
Measured values Measured values

Low
True values True values

WORLD HEALTH ORGANIZATION

A high reliability means that in repetaed measurements the results fall very close to each other; conversely,
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reliability means that they are scattered. Validity determines how close the mean of repeated measurements is to
the true value. A low validity will produce more problems when interpreting results than a low reliability.
 Internal Validity and External
Validity
INTERNAL VALIDITY
Internal validity is the degree to which the results of a
study are correct for the sample of patients being studied.

It is internal because it applies to the conditions of the

particular group of patients being observed and not
necessarily to others.

The internal validity of clinical research is determined by

how well the design, data collection, and analyses are
carried out and is threatened by all of the biases and
random variation.
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EXTERNAL VALIDITY
External validity is the degree to which the results of
an observation hold true in other settings. Another
term for this is generalizability.

For an individual clinician, it is an answer to the

question, Assuming that the results of a study are
true, do they apply to my patients as well .

Generalizability expresses the validity of assuming

that patients in a study are similar to other patients
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ALL patients with the INTERNAL VALIDITY
conditions of interest

Sampling
SAMLPE SAMLPE

Selectio
n Bias

? Measurement
and confounding
??
bias
chanc
e
EXTERNAL
VALIDITY CONCLUSION
(generalizability)
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Figure 4. INTERNAL AND EXTERNAL VALIDITY
Figure 5. Assessing the relationship between a possible cause and an outcome

OBSERVED ASSOCIATION
Could it be due to selection or
measurement bias ?

NO

Could it be due
to confounding ?

NO

Could it be a result
of chance ?

PROBABLY NOT

Could it be causal

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Apply guidelines and make judgement
 WORLD HEALTH ORGANIZATION
The figure describes the steps involeved in analysing causation.
Firstly, the possibility of selection or measurements bias must be
examined. Secondly, confounding should be considered. Thirdly,
statistical analysis should be used to determine the probability of
the findings having occurred by chance. If these three possible
explanations for an apparent association can each be ruled out,
the issue of causation can then be tackled.

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