RESEARCH METHODOLOGY
By Immaculate A
STUDY DESIGN
This is a specific plan or protocol for conducting
the study, which allows the investigator to
translate the theoretical theory into an
operational one.
They constitutes measures of data collection,
measurement of variable and analysis.
MEASUREMENT SCALES
NOMINAL
The nominal scale applies to data that are
used for category identification. The nominal
variable is characterized by data that consist
of names, labels, or categories only.
The data do not have any units of
measurement.
Nominal scale data cannot be arranged in an
ordering scheme.
Example: blood group types- O, A, B, AB,
Religion-muslim, catholic, Gender of child-
male, female, Cause of death of newborn-
congenital malformation, asphyxia, . . .
ORDINAL
The this applies to data that can be arranged in
some order, but differences between data values
either cannot be determined or are meaningless.
The ordinal level of measurement is characterized
by data that applies to categories that can be
ranked. Ordinal variable data can be arranged in an
ordering scheme.
The data do not have any units of measurement (so
the same as for nominal variables).
Examples: school performance-poor, good,
excellent,
Socioeconomic class-lower, middle, upper, Pain
level- non, low, moderate, severe.
OTHER SCALES
An interval-scale variable is measured
on a scale of equally spaced units, but
without a true zero point, such as date of
birth.
• A ratio-scale variable is an interval
variable with a true zero point, such as
height in centimeters or duration of illness.
TYPES OF VARIABLES
CONTINUOUS METRIC VARIABLES
This is a quantitative variable that can
assume any numerical value over an
interval or over several intervals. Usually
results from making a measurement of
some type.
Metric continuous variables can be
properly measured and have units of
measurement.
Example: The cholesterol reading for those
individuals having cholesterol readings
equal to or greater than 200 mg/dl;
Possible values for the variable All real
numbers between 200 and b, where b is
DISCRETE METRIC VARIABLES
A discrete variable is a quantitative
variable whose values are countable.
Discrete variables usually result from
counting.
Metric discrete variables can be properly
counted and have units of measurement –
‘numbers of things’.
They produce data which are real numbers
located on the number line.
The number of defective needles in boxes
of 100 diabetic syringes, possible values
for the variable are 0,1,2,3………100.
STUDY DESIGN
CRITERIA TO CHOOSE A DESIGN
• Type of research question
• Nature of the problem
• Purpose of the study
• Time (how often); e.g. cross sectional Vs
prospective
• Sample design and size
• Data collection techniques
• Outcomes of the study
• Geographical location
• Type of data required and Source of data
TYPES OF STUDY DESIGNS
a) ANALYTICAL RESEARCH DESIGNS
Observational studies
Experimental
b) DESCRIPTIVE RESEARCH METHODS
Correlation / associating
Hypothesis generating
Population studies
OBSERVATIONAL STUDIES
Data is collected from an existing situation by
watching not asking.
Types of observational study:
Case-series.
Cross-section studies.
Comparative research designs: Cohort studies,
Case-control studies.
OBSERVATIONAL STUDIES
Advantages
Provides a complete picture of the environment
being studied
Theories are grounded solidly on observational
data
It is done over a long period
Disadvantages
It needs a fast and alert personal
It requires training
A lot of time is needed
Observer bias
CASE-SERIES
These investigate or examine in detail relatively
few persons or items for examples one person,
one health center or a village.
Such studies not only do they produce information
on behavior and practices but also underlying
ideas and beliefs.
Purpose: determine factors and r/ships among
factors that have resulted in the behavior under
study.
CROSS-SECTIONAL STUDIES
Cross-sectional surveys aim at describing
and quantifying the distribution of certain
variables in a study population at one point
of time.
They may cover, for example prevalence
surveys (of bilharzia, leprosy, HIV), or
evaluation of coverage (of immunisation,
latrines, etc.),
No cause effect relationship, hypothesis
ADVANTAGES OF CROSS SECTIONAL
STUDIES
are a one-stop, one-time collection of data
are less expensive & easier to conduct
provide much information useful for planning
health services and medical programs
show relative distribution of conditions, disease,
injury and disability in groups and populations. For
example by conducting survey in different towns,
it is possible to know which towns are highly
affected by HIV/AIDS.
COMPARATIVE STUDY DESIGNS
This design identifies factors that explain why one
group of persons or objects differs from another.
In comparative research design the research
compares one group with the problem, with
another that has no problem.
The types of comparative studies or designs:-
Casecontrol studies –Retrospective study
Cohort studies -Prospective study
COMPARATIVE STUDY DESIGNS
Advantages
Allows comparison of groups without
manipulating the independent variable
Cheap
Can identify variables worthy of experimentation
Disadv;
Interpretation limited
Third variable
CASE-CONTROL STUDIES
Study compares one study group among whom
the problem is present with another group
(control or comparison group) where the problem
is absent.
In case control studies one starts with the out
come and then looks back to determine the
presence or absence of these associated factors.
This is called a retrospective study design.
Merits: least expensive; least time-consuming;
suitable for study of rare diseases (especially
NCDs, cancers)
Limitations: liable to selection bias and recall
bias; not suitable for calculation of frequency
measures, no risk factors
RETROSPECTIVE STUDY DESIGN
One in which the focus upon the risk factor or
exposure factor for the outcome is in the past.
One type of retrospective study is the case-control
study, in which patients who have a disease of
interest to the researchers are asked about their
prior exposure to a hypothesized risk factor for
the disease.
These patients represent the case data that are
matched to patients without the disease but with
similar demographic characteristics.
COHORT STUDIES
In a cohort study a group of individual that are
exposed to a risk factor are compared with a
group of individuals who are not exposed to the
risk factor and the researcher follows both groups
overtime to compare the occurrences of the
problem.
This is called a prospective study design
COHORT STUDIES
Advantages:
Cohort studies are a relatively sure way to establish
causal relationships.
Provides incidence data
Allows for accurate measurement of exposure
variables
Disadvantages:
They take longer than case-control studies
Labor intensive,
Expensive. The major problems are usually related to
the identification of all cases in a study population,
especially if the problem has a low incidence.
Further, the following up all persons included in the
study over a number of years may be impossible
because of population movement.
PROSPECTIVE STUDY DESIGN
Prospective studies follow subjects from the
present into the future.
In the health sciences, one example is called a
prospective cohort study, which begins with
individuals who are free from disease, but who
have an exposure factor.
EXPERIMENTAL DESIGNS
An experimental study is one in which there is a
study group and a control group as well as an
independent (causal) variable and a dependent
(outcome) variable.
The investigator manipulates the independent
variable and observes its influence upon the
dependent variable. Here the IV are the
treatment.
TYPES OF EXPERIMENTAL
STUDIES
Single group
Clinical trials; randomised, double blind
Placebo control
CLINICAL TRIALS
A clinical trial is defined as “. . . an experiment
performed by a health care organization or
professional to evaluate the effect of an
intervention or treatment against a control in a
clinical environment. It is a gold standard.
It is a prospective study to identify outcome
measures that are influenced by the intervention.
A clinical trial is designed to maintain health,
prevent diseases, or treat diseased subjects.
TYPES OF TRIALS
T ria l
C o n tro lled N o t co n tro lled
R a nd o m is ed N o t ran d om is ed
B lind ed N o t b lind ed
RANDOMIZED
Study population……….randomised…………tx
And non treatment group
SINGLE GROUP DESIGNS
One short case study design
Experimental tx is administered and a post test
done to test the effects..
Disadv;
No pretest.
One group pre test-post-test design
Involves a pretest.
DESCRIPTIVE STUDIES;
Descriptive studies; this involves a systematic
collection and presentation of data to give a clear
picture of a particular situation.
Population studies; Census
This is the complete enumeration of a population
or group at a point in time with respect to well-
defined characteristics.
A population census is the collection, analysis of
basic, social demographic and economic data for
the entire population of a country.
SURVEYS
Is an attempt to collect data from members of a
population in order to determine the current
status of the population with respect to one or
more variables.
They aim at quantifying the distribution of certain
variables in a study population.
Most surveys represent cross-sectional studies.
LIMITATIONS OF SURVEYS
Depend on cooperation of respondents.
Information unknown by the respondents will
not be tapped
Requesting info which is considered secret
encourages incorrect answers.
Surveys cannot be aimed at obtaining
forecasts of things to come.
ECOLOGICAL / CORRELATION
STUDIES
These describe in quantitative terms the degree
to which variables are related.
interpre
The degree of r/ship is expressed as correlation
coefficient (r) (-1 to 1).
Steps:
Problem statement
Selection of subjects
Data collection
Data analysis using r
CORRELATION STUDIES
Advantages
Permits one to analyze inter-relationships among
a large number of variables in a single study.
Provides info concerning degree of r/ship btn
variables
Disadvantages
Correlation between two variables does not mean
causation
R is sensitive to size of sample
CONCLUSION
In cross-sectional studies, we are looking for both
exposure and outcome
In case-control studies, we know the outcome,
looking for the exposure
In cohort studies, we know the outcome, following
up looking for the outcome in question
If the population in a cross-sectional survey is
followed up to measure health outcomes, this
study design is a cohort study.
CONCLUSION
Ifthe population of such a study are,
at baseline, divided into two groups,
and the investigators impose a health
intervention upon one of the groups
the design is that of a trial.
REFERENCES;
MUGENDA O, et al, 2003. Reasearch methods
quantitative and qualitative approaches.
ACTS PRESS. Nairobi. Pp 155-180.
