Presented by,

Mrs. R. Shubha
M.Sc (N) - I Year
Psychiatry Nursing dpt
Nehru Nursing college
• An observational study draws inference from a sample to a
population where the independent variable is not under the control
of the researcher because of ethical concerns.
• Studies of risk factors:
• independent variable (exposure): risk factor
• dependent variable: disease
• Studies of interventions:
• independent variable (exposure): intervention
• dependent variable(s): selected “outcomes” (could be measures of
process and/or outcomes)
It is concerned with the study of frequency and distribution of disease

and health related events in population in terms of person, place and

time
• Provides morbitiy and mortality related data regarding the
magnitude, load and type of disease problems in the community.
• provides clues to disease etiology & helps in formulating hypothesis.
• helps in organizing & evaluating preventive and curative services.
• describes variations in disease occurence thus contributing to
research.
The main goal is not to formulate hypothesis

but to test hypothesis.

• Meaning :-
An “observaitonal” design that
surveys exposures and disease at a
single point in time
• In a cross-sectional study, the
investigator measures the
outcome and the exposures in
the study participants at the
same time.
• Cross-sectional study designs may be used for population-based
surveys
• Cross-sectional studies may also be used for estimating the
prevalence in clinic-based studies.
• Feasible, relatively easy to administer
• useful in health planning
• to assess the burden of disease
• Cross-sectional studies can usually be conducted relatively faster and
are inexpensive
• These study designs may be useful for public health planning,
monitoring, and evaluation.
• These are studies are conducted either before planning a cohort
study or a baseline in a cohort study. These types of designs will give
us information about the prevalence of outcomes or exposures; this
information will be useful for designing the cohort study
• Tough to find people that fall under the exact same variable

• These studies are also prone to certain biases.

• associations are tough to interpret

• does not help to determine cause

• DEFINITION
“The observational epidemiologic study of persons with the disease of
interest and a suitable control group of persons without disease”
- John.M.Last (2000)

A case control study involves 2 populations

i. cases
ii. controls
SELECTION OF CASES

SELECTION OF CONTROLS

MATCHING

INFORMATION ON EXPOSURE

ANALYSIS AND INTERPRETATION

Example:
• Cohort means “Persons banded together”
In Latin , it is a group of people who share a common
characteristics experience.
e.g. age, birthdate etc..
DEFINITION:
“Cohort study is a type of analytical study ehich is undertaken to
obtain additional evidences to support existence of association
between suspected cause and disease”
Example of cohort study
incidence can be calculated

provides direct estimation of risk

bias can be minimized

allows the conclusion of cause effect relationship

Not good for rare diseases because of the long time wait to observe
enough cases, or for long latency periods because individuals must be
followed for a long time.
Exposures are limited to those having been chosen at the beginning
of the study.
A problem with complex traits is that there is almost always a new
exposure that was not built into the study design
Study itself may alter patients behaviour
time consuming and expensive
 Interventional studies, also called experimental studies, are
those where the researcher intercedes as part of the study design.
An experiment is the best epidemiological study design to prove
causation.
It can be viewed as the definitive step in reasearch process
DEFINITION:
“RCTs are quantitative, comparative, controlled experiments in which
investigators study two or more interventions in a series of individuals who
receive them in random order”

- Stedman's Medical Dictionary

RCT is a gold standard for evaluating health care technologies and also it the
number one evalution method for new therapies.
Example of RCT
 It involves the manipulation of independent variable to

observe the effect of dependent variable.

NON-RANDOMIZED CONTROL DESIGN

TIME SERIES DESIGN

• Is also known as “non equivalent control group design”.
• This design is identical to the pre test- post test group design, except
there is no random assignment of the study subjects in experimental
and control groups.
• In this design experimental and control groups are selected without
randomization. • Dependent variables are observed in experimental
as well as control groups before the intervention.
• Later the experimental group receives treatment, following which the
post test observation of dependent variable is carried out for both the
groups to assess the effect of the intervention or treatment on
experimental group.
• Time series design is useful when the researcher intends to measure
the effects of a treatment over a long period of time. • The researcher
would to continue to administer the treatment and measure the
effects a number of times during the course of the experiment.
• In a single - subject research, in which the researcher carries out an
experiment on an individual or on a small number of individuals, by
alternating between administering and then withdrawing the
treatment to determine the effectiveness of the intervention.
EXAMPLE

Measurement of a learner’s performance in a college on weekly

basis and then introducing a new teaching technique. Then again
measuring on weekly basis.
• Quasi experimental designs are more frequently used because they
are more practical and feasible to conduct research.
• Where the sample size is small, and where randomization &
availability of control group is not possible, this design is preferred.
• Quasi experimental design is more suitable for real natural world
setting than true experimental designs.
• This design allows the researchers to evaluate the impact of quasi
independent variables under naturally occurring conditions.
• In some cases hypotheses are practically answered through this
design.
• In this design there is no control over extraneous variables influencing
the dependent variable.
• The absence of a control group and absence of control over the
research setting makes the result of this design less reliable and weak
for the establishment of causal relationship between independent &
dependent variable.