NON

EXPERIMENTAL/OBSERVATION
AL STUDY DESIGNS
Many research problems cannot be addressed with experimental

designs.

Sometimes, it not possible to conduct experimental studies where

ethical issue is raised, or the independent variable or factor has

negative impact on human being.

In observational studies, subjects are observed and no

intervention is done, for example, patients with cardiac disease

who consume alcohol are compared with similar patients who do

not consume alcohol to find if there is any difference in cardiac

events between two groups.

 Classification
1. Descriptive studies
Case study
Case series study
Cross sectional
2. Retrospective study
Case-control study
3. Prospective study
Cohort study
Follow-up study
Longitudinal study
Panel study
Time series or trend study
 Descriptive Studies
The descriptive studies are those
which describe the occurrence of
disease or disease related
phenomena in population.
 Case Studies
Case studies involve an in-depth examination of a single person or

single individual or single institution / hospital.

The goal of case study is to provide an accurate and complete

description of the case, the principal benefit of case-study is that it-

can expand our knowledge about the human behavior or attitude.

It is also useful when the case is too-complex and need special

attention.

Case study often include in-depth interviews with participant, review

of his/her medical record, observation.

It provides an opportunity for the intensive analysis of many specific

details, which are often over looked by other methods.

 Case Series Studies
A case series simply describes the clinical presentation

of a disease in a number of patients at a particular time.

It does not follow the patients for a period of time, and it

uses no control group.

Generally patients are seen for a short period of time.

A case series study cannot establish any cause-effect

relationship, and the fact that the researcher has no

control group to compare the cases.

 Despite this shortcoming, case series
studies are commonly used to present
new information about patients.
A case report is a special form used to
collect the information from a single
patient.
Since there is no control group with
which to compare outcomes, so there
is no statistical validity.
 Limitations of Case Study and
Case Series
Case Study : It is restricted to
personal experience and there is no
planned investigation.
Case Series : There is no
comparison.
 Cross Sectional Studies
Cross sectional studies analyze the data collected on a group of

subjects at one time rather than over a long period of time.

Cross sectional designs studied to learn what is happening? right now.

Subjects are selected and information is obtained in a short period of

time.

Cross sectional studies focus on a point in time; they are also called

prevalence survey.

This study determines the proportion of people who are diseased (this

is the prevalence of disease) and to examine the relationship between

the disease and other variables or characteristics of the population.

Prevalence surveys or cross sectional studies are very much common in

medical sciences.
 Although they may be expensive and laborious to

carry out, prevalence surveys or cross sectional

studies are common because they have the potential

to produce very valuable data about a wide range of

diseases, behavior and characteristics which can be

used to generate several hypothesis for more

analytical studies to examine.

Cross-sectional designs are especially appropriate for

describing the status of association among

phenomena at a fixed point.

 The main advantage of the cross-
sectional study is that this is economical
and easy to manage and conduct.

The disadvantage of this design is that,

there are frequently alternative
explanations for any observed
phenomena.
Tests of Association & Measure
of Relationship
Chi-square test is used to assess the
relationship between categorical
variables and Pearson correlation
coefficient is used to measure
relationship for continues variables.
 Merits & Demerits
It is less time, consuming.

Useful for further studies.

Useful for assessing point prevalence.

Helpful in assessing health status of

community.
It is not useful to study incidence of disease.

Not useful for rare disease.

 Prospective & Retrospective
Study Design
In prospective design, the research follows the
participants and observes or measures the
characteristics of the participants.

The researcher waits for the future events.

If randomization process is used the study is called

clinical trail, otherwise cohort study.

For example, in prospective (cohort study) lung cancer

study, the investigator starts with sample of smokers
and non-smokers and later compare the two groups in
terms of lung cancer incidence.
 Where as the retrospective studies are ex-post facto
investigations in which a phenomena observed in the
present is linked to the phenomena occurring in the
past.

In this situation, the investigator first takes the sample

of patients then tries to link it with some cause.

For example the retrospective lung cancer study, the

investigator begins with a sample of those who have
lung cancer and sample who do not.

Then the investigator then looks difference between the

groups in antecedent behavior such as smoking habits.
Benefits of Observational Studies

What was happened?

(Retrospective)
What is happening? (Cross-sectional)
What will happen? (Cohort or
prospective)
 Retrospective study (What was happened)
In this method, we first select the subject with a given disease (cases)

and the subjects without disease (control), and then find to the

proportion at each who have been exposed to possible risk factors.

Consider the relationship between maternal anemia and birth weight.

In this study select the children from birth weight categories (Low and

normal), and go back to the records to find the Hb level of their mothers

during the antenatal periods.

This is a retrospective design, since this goes from known outcome to

the risk factor (antecedent).

If we have only two categories, this is called case-control study.

These studies are less expensive, need short time and sample size.

The statistical method to analyze the data is Odds-ratio (OR).

 Case Control Studies
This design involves comparing cases with a
certain condition (women with breast cancer)
with control (women without breast cancer)
who are selected to be similar to the case with
regards to key factors (age, family history) in
this design we compare people who do have
the disease (case) with similar people who do
not have the disease (control).
 Case-control studies therefore start with out
come (the presence or absence of disease), then
look back into the past for possible causes of the
disease.
Sometimes this study is called retrospective
study.
So in the case-control study, the investigator
gathers the data at once and then looks into the
past of the participant to classify them.
Odds-ratio (OR) is used to analyze the data.
 Advantages &
Disadvantages
The advantages of this study one;
(i) it can be performed quickly and
cheaply.
(ii) This requires comparatively few
subjects. The disadvantages of such
studies on
(i) selection of control group is
difficult
(ii) peoples recall of their behavior
may be biased.
 Advantages of Case-Control
Study
Feasible when disease being occurs
only rarely, cancer of specific organ.
Relatively efficient, requiring a
smaller sample than Cohort Study.
Sometimes they are used to
establish association.
 Disadvantages of Case-Control
Studies
Measurement bias may exist.

It may be difficult to obtain

information on exposure, if recall
period is long.
Fault of selection of case and control.
 Prospective or Cohort Studies
(What will happen)
Prospective study is an epidemiological study in which the group

of individuals is selected on the bases of factors that are to be

examined for possible effect on same outcome.

In this study the effect of exposure to specific risk factor on

eventual development of particular disease can be studied.

The advantage of prospective study is that base line

examinations are possible at the start and follow-up can be

planned, but this study is time consuming and costly.

Through prospective study we measure incidence of disease and

effect of exposure.
 Cohort Study
A Cohort Study follows-up a group from exposure to

outcome.

Cohort Study focuses on factors related to the

development of the disease.

In Cohort all participants are free from disease at

beginning of study and those are followed over an

extended period of time.

Cohort means a group of people which are taken for

specific purpose.

In Cohort Study, it is necessary to understand that the

 Advantages of Cohort Studies
Can establish population-based incidence
Accurate relative risk (risk ratio) estimation

Can examine rare exposures (asbestos, lung cancer)

Temporal relationship can be inferred (prospective design)

Time-to-event analysis is possible.

Can be used where randomization is not possible.

Magnitude of a risk factors effect can be quantified

Selection and information biases are decreased

Multiple outcomes can be studied (Smoking, lung cancer,

COPD, larynx cancer)

 Disadvantages of Cohort
Studies
Lengthy and expensive

May require very large samples

Not suitable for rare disease

Not suitable for diseases with long-latency

Unexpected environmental changes may influence

the association

Non response, migration and loss-to-follow-up biases

Sampling, ascertainment and observer biases are

still possible
 Follow-up Study
Follow up studies are under taken to
determine the subsequent status of
subjects (patients) with a special condition
and those receiving a special intervention.
For example, Miles and nelson (1999)
conducted a follow-up study of 67 mothers
whose infants has serious life-threatening
illness.
 Longitudinal Study (Repeated
Measures)
This type of study is designed to collect data over an
extended period of time with repeated observations of
same variables over long period of time.

It is used to study the developmental trend or

development of disease related to certain factors.

It is also used to uncover predictors of certain disease.

Longitudinal design are more powerful then cross-

sectional due to repeated measures and less powerful
then RCT because absence of control over respondents.
 Panel Study
Panel study is an observational study, where observations are made over

an extended period of time and are prospective in nature.

In panel study same participants supply data at two or more point in

time.

In panel study, the investigator can examine pattern of change and

reason for change.

In this study, the investigator identifies the pattern of change in those

who are responsible as compare to those who are not.

Panel study design is very useful, but difficult to manage.

The most serious problem is loss of participants at different point.

It is noticed to remember, panel study participants are of same nature,

behavior socio-economic status and education.

 Time Series or Trend Study
If some one wants to record changes over a period, with

respect to some phenomena, trend studies are most

appropriate method of investigation.

Trend series enables us to find out what has happened in past,

what is happening and what will likely to happen in future.

This study is also useful to forecast trend by extrapolation

from present and past trend.

For example trend studies have been conducted to analyze

the number of students entering physiotherapy programs and

to forecast future supply of such professionals.

 Criterion Prospective Retrospectiv Cross-sectional
e
Cost and High Low Low
time
Suitable for Rare Rare None should be
antecedents outcomes rare
(past history)
Loss of High chance Low chance No chance
information
Assessment Good Fair Poor
cause of
effect