PRINCIPLES OF

EPIDEMIOLOGY
• Rates are particularly useful for
comparing disease frequency in different
locations, at different times or among
different groups of persons with
potentially different sized populations,
that is rate is a measure of risk.
- Doctor-Patient Ratio
• Ratios can describe the male-to-female
ratio of participants in a study, or the
ratio of controls to cases (e.g., two
controls per case).
• Ratios can be calculated for occurrence
of illness, injury, or death between two
groups.
• A proportion is the comparison of a part to
the whole.
• It is a type of ratio in which the numerator is
included in the denominator.
• A proportion may be expressed as a decimal,
a fraction, or a percentage.
Ex: Proportion of children in a village vaccinated
against measles, etc
 Randomized Conool Trials
(RCT)
• RCT is a planned experiment designed to asses the
efficacy of an intervention in human beings by
comparing the effect of intervention in a study group to a
control group.

• The allocation of subjects to study or control is determined

purely by chance (randomization}.

• For new programme or new therapy RCT is best method of

evaluation.
 Basic Steps in RCT
1. Drawing-up a protocol.
2. Selecting reference and experimental
population.
3. Randomization.
4. Manipulation or Intervention.
5. Follow-up.
II. Assessment of outcome.
 RANDOMIZATION outcome
Intervention
no outcome

Study
population
outcome
Control
no outcome

baseline
future
Experimental Design

time
Study begins here (baseline point) 89
 1. Designing the Protocol
• Study conducted under strict protocol.
• Protocol specifies —
• Aim, objectives, criteria for selection of study and control
group, sample size, intervention applied, standardization
and schedule and responsibilities.

• Pilot study —
• Some times small preliminary study is conducted to find out
feasibility or operational efficiency.
 2.Reference and Experimental population
• Reference population (Target Population)
• 1s the population in which the results of the Study is applicable.
• A refercnce population may be - Human being, country, specific age,
sex,
occupation etc.

• Experimental Population (Study Population}

• It is derived from the target population,
• Three criteria-
• 1. They must be representative of RR
• 2. Qualified for the study.
• S. Ready to give informed consents.
 3.Randomization
• It is statistical procedure to allocate participants in groups
—
Study group and Control group.

• Randomization gives equal chance to participants to be

allocated in Study or Control group.

• Randomization is an attempt to eliminate ‘bias’ and allow

comparabiliiy’.
• Randomization eliminates ‘Selection Bias’.

• Matching is for only those variable which are known.

• Randomization is best done by the table of random numbers.

• In Analytical study there is no randomization, we already

study the difference of risk factor. So only option is
Matching.
 4. Manipulation
• Manipulation by application of therapy or reduction or
withdrawal of suspected causal factor in Study and
control group.

• This manipulation creates independent variable whose elect is

measured in final outcome.
 Blinding
• Blinding is an essential component of clinical trials,
undertaken with a view to prevent measurement bias that
may occur if the subjects in the trial or the epidemiologist
conducting the trial is aware of about which group the
subject being evaluated belongs to.
• Simply blinding is a procedure to eliminate bias.
Three types -
1. Single blind trial.
Participant not aware of study group they belong to.
2. Double blind trial.
Examiner and participant both not aware study groups.
3. Triple blind trial.
Participant, examiner and person analyzing the data not aware of the
study groups.
 5. Follow-up
• Follow-up of both study and control group
in standard manner in definite time period.

• Duration of trial depends on the changes expected

in duration since study started.

• Some loss of subjects due to migration, death is

known as Attrition.
 6. Assessment
• Final step is assessment of outcome in terms of positive and
negative results.

• The incidence of positive and negative results are compared

in
both group- Study eroup and Control eroup.

• Results are tested for statistical significance. (p value)

 Potential errors in epidemiological
studies (Bias)
• Bias may arise from the errors of assessment of outcome
due
to human element.
• Three sources —

I. Bias on part of subject.

2. Observer bias.

3. Bias in evaluation.