RESEARCH DESIGN

INTRODUCTION
Research design and research approach are two terms that are
frequently used interchangeably, however research design is a broader plan
to conduct a study and research approach is an important element of the
research design, which designs it. A research design is the heart and soul of
a research project. It outlines how the research project will be conducted and
guides data collection, analysis and report preparation. A good research
although forms broad approach to the problem that has already been
developed and research design specifies the nuts and bolts of implementing
that approach. It includes the descriptions of the research approaches,
dependent & independent variables, sampling design and a planned format
for data collection, analysis and presentation.

DEFINITION
1. The overall plan for addressing a research question, including
specifications for enhancing the studys integrity.
(Polit)

2. A research design is a framework or blueprint for conducting the

research project
(Naresh Malhotr)

3. A research design is a blueprint for conducting the study that

maximizes control over factor that could interfere with the validity
of findings

(Chris Jordan)
PURPOSES OF RESEARCH DESIGN
1. To find an answer to the research question.
When selecting a research design, the researcher crystallizes what is
known to date about a certain phenomenon or set of phenomenon or set of
phenomena, explanations and counter explanations as well as possible
causes and potential confounds. At the same time, the research design is the
platform from which the researcher explores new knowledge in an effort to
better describe and understand phenomena, clarify plausible explanations
and identify
2. The research design provides the backbone structure of a study
It determines how the study will be organized, when data will be
collected and when interventions, if any, are to be implemented. The
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research design is also a statement of commitment by the researcher to
organize a study, maximize objectivity and use generally accepted methods
of inquiry that safeguard researchers from drawing incorrect inferences and
conclusions from their investigations

CHARACTERISTICS OF A GOOD RESEARCH DESIGN

The following are the characteristic features of good research
design:
1. Appropriate for research question: The research design should be
appropriate for the questions being asked.
2. Lack of bias: A good research design will collect and store data which
is not biased. The most source of bias is in allocation of subjects to
groups eg., when groups are formed as a non random basis. In studies
in which the data are collected by means of observation, the
researchers preconceptions might unconsciously bias the objective
collections of data.
3. Precision: Precision refers to the appropriateness and accuracy of the
statistical procedures used to analyze data.
4. It is a plan that specifies the sources and types of information relevant
to the research problem.
5. It is a strategy specifying which approach will be used for gathering
and analyzing the data.
6. It specifies the time and cost budgets since most studies are done
these two constraints.

CLASSIFICATION OF RESEARCH DESIGN

The research design is broadly classified under two headings as

follows:

Quantitative Qualitative
research design research design

1.Pnenomenological
Experimental design Non experimental design 2. Ethnographic
3. Grounded theory
True 4. Historical
Survey
experimental 5. Case studies
Quasi Correlational
2
experimental Comparative
Preexperimental
Methodological
 1. Quantitative research design: Quantitative research design is a
formal objective systematic process in which numerical data are
collected and analyzed using statistical methods to obtain information
about the world. It is quantifying the relationship between variables.
The concepts such as randomization, control, manipulation,
measurement, statistical analysis, etc are strongly or broadly
associated.
2. Qualitative research design: Qualitative research design involves
analysis of data such as words (e.g. from interviews), pictures
(e.g.video), or objects (e.g. an artifact).

DIFFERENCES BETWEEN QUALITATIVE AND QUANTITATIVE RESEARCH

DESIGN
Qualitative Design Quantitative Design
The aim is a complete, detailed The aim is to classify features, count
description. them,
and construct statistical models in an
attempt to explain, what is observed
Researcher may only know roughly in Researcher knows clearly in advance
advance what he/she is looking for. what he/she is looking for.

Recommended during earlier phases Recommended during latter phases

of research projects. of research projects.
The design emerges as the study All aspects of the study are carefully
unfolds. designed before data is collected
Researcher is the data gathering Researcher uses tools, such as
instrument. questionnaires or equipment to
collect
numerical data.
Data is in the form of words, pictures Data is in the form of numbers and
or objects. statistics.
Subjective - individuals ObjectiveSeeks precise
interpretation of events is important, measurement and analysis of target
e.g. uses participant observation, in- concepts, e.g. uses surveys,
depth interviews etc. questionnaires etc.
Qualitative data is more rich, time Quantitative data is more efficient,

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consuming, and less able to
be able to test hypotheses, but may
generalized. miss contextual detail &
generalizable
Researcher tends to become Researcher tends to remain
subjectively immersed in the subject objectively separated from the
matter. subject matter.

ELEMENTS OF RESEARCH DESIGN

Approach: It involves the description of the plan to investigate the

phenomenon under study in a structured, unstructured and combination of
two methods.
Subjects: Research design also provides the researcher with directions
about population, sample and sampling technique, which will be used for the
research study.
Variables: Variables are the focus of the study and reflect the empirical
aspects of the concepts being studied, the investigator measures variable.
Time: The time element of design is the frequency (how often) and the order
(when) in which observations are made.
Setting: Setting may be natural or laboratory setting depending upon study
topic and researchers choice.
Tools and methods of data collection: This element of research design
involves the description of different tools and methods of data collection, for
example, questionnaires, interviews, direct observation or any other
methods that suit the particular approach of the research as well as nature of
the phenomenon under study.
Methods of data analysis: A research design must also include the
description of the methods of data analysis- either quantitative or qualitative
data analysis techniques that helps the researcher to collect the relevant
data, which later can be analyzed as per the research design plan.
Investigators role: Investigator remains unobtrusive, attempting not to
influence the variables being studied. In other studies the investigator
imposes control on many variables, actively manipulates some of the
variables being studied and allocates the participants to different conditions.

SELECTION OF RESEARCH DESIGN

The selection of research design may be influenced by several factors
of which some of the important ones are listed below
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 Nature of the research problem: This is the most important factor,
which helps the researcher to decide about the selection of a research
design. Based on the nature of research problem or phenomenon,
researchers decide whether it should be investigated through an
experimental, quasi-experimental or non experimental approach.
Purpose of the study: study may be conducted for the purpose of
prediction, description, exploration or correlation of the research
variables. Therefore, the purpose of the research study helps the
researcher to choose a suitable research design.
Researchers knowledge and experience: Selection of research
design is largely influenced by the researchers knowledge and
experience, because they avoid using those designs wherein they lack
confidence, relevant knowledge or experience. Hence the awareness
of and expertise in existing research designs are important factors
pertaining to the researchers.
Researchers interest and motivation: Interest and motivation
levels help researchers decide about the particular research design.
Motivated researchers always analyze most aspects of research design
before selecting or a combination, while researchers may choose
research design that may lead to failure.
Research ethics and principles: The incorporation and ethical and
legal principles in the research design are essential. This includes
moral obligations such as respect for participants and their rights,
informed consent and protection from harm, including any adverse
effects to educational progress, health and wellbeing
Study participants: The number and availability of study subjects
may influence the selection of research design. If only few subjects are
involved, an in-depth qualitative research design study may be chosen
method, but in case of a large sample, the researcher may opt for a
quantitative research design.
Resources: None of the researchers can be conduct without
resources such as money, equipments, facilities and support from
colleagues. However, some of the studies require more amounts of
resources as compared to others. Therefore, the selection of a
research design may be affected by the availability of resources for
the research study.

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 Time: Time is also a major deciding factor for the selection of
research design. For example a researcher needs more time to
conduct longitudinal studies, while cross-sectional studies may be
conducted in shorter time. Therefore, time is also a significant
contributing factor in selection of a research design.
Possible control on extraneous variables: An efficient design can
maximize results, decrease errors and preexisting or impaired
conditions that may affect the outcome of the study. The maximized
efforts of the researcher should maximize control.
Users of the study findings: A research design also involves
various methods of data collection and analysis. Therefore, while
choosing a research design, researcher must ensure that research
design is as appropriate for the users of the study findings as possible,
so that maximum advantage of the results can be obtained.

VALIDITY OF RESEARCH DESIGNS

Methods that can be used to strengthen a wide array of quantitative
research designs, including ways to enhance rigor through control over
extraneous variables. There are two basic types of extraneous variables:
those that are intrinsic to subjects and those that are external, stemming
from the research situation.

1. Internal Validity
Internal validity refers to the extent to which it is possible to make an
inference that the independent variable is truly causing or influencing the
dependent variable and that the relationship between the two is not the
spurious effect of an extraneous variable.
2. External Validity
The degree to which study results can be generalized to settings or
samples other than the one studied.

Methods to control Instrinsic source of confounding variability

1. Randomization
The most effective method of controlling individual extraneous
variables randomization. The primary function of randomization is to
secure comparable groups, that is, to equalize groups with respect to
extraneous variables. A distinct advantage of random assignment, compared
with other control methods, is that randomization controls all possible
sources of extraneous variation, without any conscious decision on the
researchers part about which variables need to be controlled.
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 2. Repeated Measures
When subjects are exposed to two different conditions, they may be
influenced in the second condition by their experience in the first.

3. Homogeneity
When randomization and repeated measures are not feasible,
alternative methods of controlling extraneous characteristics should be used.
One such method is to use only subjects who are homogeneous with respect
to confounding variables. The extraneous variables, in this case, are not
allowed to vary. Using a homogeneous sample is easy and offers
considerable control. The limitation of this approach lies in the fact that
research findings can be generalized only to the type of subjects who
participated in the study.
4. Blocking
Another approach to controlling confounding variables is to include
them in the research design through stratification. For example, physical
training program of oldage people, if gender were thought to be a
confounding variable, we could build it into the study in a randomized block
design. In such a design, elderly men and women would be randomly
assigned separately to the treatment group or control group. This approach
has the advantage of enhancing the likelihood of detecting differences
between our experimental and control groups because we can eliminate the
effect of the blocking variable (gender) on the dependent variable. In
addition, if the blocking variable is of interest substantively, this approach
gives researchers the opportunity to study differences in groups created by
the blocking variable (e.g., men versus women).
5. Matching
Matching (also known as pair matching) involves using knowledge
of subject characteristics to form comparison groups. If matching were to be
used in physical training program and age and gender were the extraneous
variables, we would need to match each subject in the physical training
group with one in the comparison group with respect to age and gender.
Matching is problematic for the following reasons, First,
to match effectively, researchers must know in advance what the relevant
extraneous variables are. Second, after two or three variables, it often
becomes impossible to pair match adequately.
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 6. Statistical control
Another method of controlling confounding variable is through
statistical analysis rather than research design. It enhances ability to detect
and interpret relationships and relatively economical means of controlling
numerous extraneous variables. But it has got limitations such as it requires
knowledge of which variables to control, and requires measurement of those
variables and requires statistical sophistication

Threats to Internal Validity

Internal validity is the degree to which it can be inferred that the
experimental intervention (Independent variable), rather than uncontrolled,
extraneous factors is responsible for observed effects. True experiments
possess a high degree of internal validity because the use of manipulation,
randomization, and a control group usually enables the researcher to rule out
most alternative explanations for the results. Researchers who use quasi-
experimental, preexperimental, or correlational designs must always contend
with competing explanations for obtained results.

1. History: The threat of history refers to the occurrence of external events

that take place concurrently with the independent variable that can affect
the dependent variables. For example, suppose we were studying the
effectiveness of a county-wide nurse outreach program to encourage
pregnant women in rural areas to improve their health-related practices
before delivery (e.g., better nutritional practices, cessation of smoking,
earlier prenatal care). The program might be evaluated by comparing the
average birth weight of infants born in the 12 months before the outreach
program with the average birth weight of those born in the 12 months
after the program was introduced, using a time series design. However,
suppose that 1 month after the new program was launched, a highly
publicized docudrama regarding the inadequacies of prenatal care for
poor women was aired on national television. Infants birth weight might
now be affected by both the intervention and the messages in the
docudrama, and it becomes impossible to disentangle the two effects.
2. Selection. Selection encompasses biases resulting from preexisting
differences between groups. When individuals are not assigned randomly
to groups, there is always a possibility that the groups are nonequivalent.
They may differ in ways that are subtle and difficult to detect. If the
groups are nonequivalent, differences on outcomes may result from initial
differences rather than from the effect of the independent variable. For

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 example, if we found that women with a fertility problem were more likely
to be depressed than women who were mothers, it would be impossible to
conclude that the two groups differed in depression because of
differences in reproductive status; women in the two groups might have
been different in terms of psychological adjustment from the start.
3. Maturation: Maturation refers to processes occurring within subjects
during the course of the study as a result of the passage of time rather
than as a result of a treatment or independent variable. Examples of such
processes include physical growth, emotional maturity, fatigue, and the
like. Maturation here does not refer to aging or development exclusively
but rather to any change that occurs as a function of time.
4. Testing: Testing refers to the effects of taking a pretest on subjects
performance on a posttest. It has been documented in several studies,
particularly in those dealing with opinions and attitudes, that the mere act
of collecting data from people changes them. Suppose we administered to
a group of nursing students a questionnaire about their attitudes toward
assisted suicide. We then acquaint them with various arguments that
have been made for and against assisted suicide, outcomes of court
cases, and the like. At the end of instruction, we give them the same
attitude measure and observe whether their attitudes have changed. The
problem is that the first administration of the questionnaire might
sensitize students, resulting in attitude changes regardless of whether
instruction follows.
5. Instrumentation: Another threat related to measurements is the threat
of instrumentation. This bias reflects changes in measuring instruments or
methods of measurement between two points of data collection. For
example, if we used one measure of stress at baseline and a revised
measure at follow-up, any differences might reflect changes in the
measuring tool rather than the effect of an independent variable.
Instrumentation effects can occur even if the same measure is used. For
example, if the measuring tool yields more accurate measures on the
second administration (e.g., if the people collecting the data are more
experienced) or less accurate measures the second time (e.g., if subjects
become bored or fatigued), then these differences could bias the results.
6. Mortality: Mortality is the threat that arises from differential attrition in
groups being compared. The loss of subjects during the course of a study
may differ from one group to another because of a priori differences in
interest, motivation, health, and so on. For example, suppose we used a
nonequivalent control group design to assess the morale of nurses from

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 two different hospitals, one of which was initiating primary nursing. The
dependent variable, nursing staff morale, is measured in both hospitals
before and after the intervention. Comparison group members, who may
have no particular commitment to the study, may decline to complete a
posttest questionnaire because of lack of incentive.

External Validity
The term external validity refers to the generalizability of the research
findings to other settings or samples. Research is almost never conducted to
discover relationships among variables for a specific group of people at one
point in time. The aim of research typically is to reveal enduring
relationships, the understanding of which can be used to improve human
health and well-being. If a nursing intervention under investigation is found
to be successful, others will want to adopt it. Therefore, an important
question is whether the intervention will work in another setting and with
different patients. A study is externally valid to the extent that the sample is
representative of the broader population, and the study setting and
experimental arrangements are representative of other environments.

External Validity and Sampling

One aspect of a studys external validity concerns the adequacy of the
sampling design. If the research sample is representative of the population,
then generalization is straightforward.

Threats to External Validity

In addition to characteristics of the sample that limit the
generalizability of research findings, there are various aspects of the
research situation that affect the studys representativeness and, hence, its
external validity. These characteristics should be taken into consideration in
designing a study and in interpreting results. Among the most noteworthy
threats to the external validity of studiesparticularly those involving an
interventionare the following five effects:
1. Expectancy effects:
Hawthorne Effect: It is a psychological response in which the subjects
alter their behaviour because they are aware of their participation in a study
and this is called Hawthorne effect. It is the effect on the dependant variable
resulting from subjects awareness that they are participants under study. The
Hawthorne effect derives its name from the Hawthorne experiment
conducted by Elton Mayo at the Hawthorne works of the Western Electric
Corporation in which various environmental conditions, such as light and
working hours, were varied to test their effects on worker productivity.
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 Regardless of what change was introduced ie., whether the light was made
better or worse, production increased. Thus, it seems that the knowledge of
being included in a study may be sufficient to cause people for change in
their behaviour. Thus obscuring the effect of the treatment. It can be
controlled by conducting double blind studies where neither the researcher
nor the participants are aware of the particular group in which they are being
included.

Placebo effect: A placebo or pseudo intervention presumed have no

therapeutic value; for example in studies of the effectiveness of drugs, some
patients get the experimental drugs and others get an innocuous substance
(effect of sucrose on infant pain during immunization, administration of
either sucrose solution or sterile water). Placebos are used to control for the
nonpharmaceutical effects of drugs, such as the attention being paid to
subjects. In such studies, there can be placebo effects ie., changes in the
dependent variable attributable to the placebo condition because of subject
expectation.
Nocebo effect: Adverse side effect experienced by those receiving a
placebo treatment.
2. Novelty effects: When a treatment is new, subjects and research agents
alike might alter their behavior in various ways. People may be either
enthusiastic or skeptical about new methods of doing things. Results may
reflect reactions to the novelty rather than to the intrinsic nature of an
intervention; once the treatment is more familiar, results might be different.
3. Interaction of history and treatment effect: The results may reflect the
impact of the treatment and some other events external to the study. When
the treatment is implemented again in the absence of the other events,
different results may be obtained. For example, if a dietary intervention for
people with high cholesterol levels was being evaluated shortly after
extensive media coverage of research demonstrating a link between oat
bran consumption and reduced cholesterol levels, it would be difficult to
know whether any observed effects would be found again if the intervention
were implemented several months later with a new group of people.
4. Experimenter effects: Subjects behavior may be affected by
characteristics of the researchers. The investigators often have an emotional
or intellectual investment in demonstrating that their hypotheses are correct
and may unconsciously communicate their expectations to subjects. If this is
the case, the results in the original study might be difficult to replicate in a
more neutral situation.

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5. Measurement effects: Researchers collect a considerable amount of data
in most studies, such as pretest information, background data, and so forth.
The results may not apply to another group of people who are not also
exposed to the same data collection (and attention-giving) procedures.
6. People: For example people of a specific race such as whites have high
prevalence of coronary artery disease compared to the blacks. Therefore, a
generalization made for whites will not be applicable for blacks.
7. Place: For example people living in high altitude have high haemoglobin
levels because at higher altitudes the requirements of oxygen is more, so a
generalization for people of hilly areas is not applicable for people living on
plains.
8. Time: If a researcher was carried out on a community in 1990 and then
again in 2000, the results of these two researchers would be different.
Therefore, older results cannot be generalized over periods of time as society
and circumstances constantly change.

EXPERIMENTAL DESIGN
An experiment is a scientific investigation in which observations are
made and data are collected according to a set of well defined criteria. In an
experiment, researchers are active agents not passive observers. Early
physical scientists learned that although pure observation of phenomena is
valuable, complexities occurring in nature often made it difficult to
understand important relationships. This problem was handled by isolating
phenomena in a laboratory and controlling the conditions under which they
occurred. The controlled experiment is considered by many to be an ideal
the gold standard for yielding reliable evidence about causes and effects.
The strength of true experiments lies in the fact that experimenters can
achieve greater confidence in the genuineness of causal relationships
because they are observed under controlled conditions.

DEFINITION
Experimental research design is an empirical research method used to
examine a hypothesized causal relationship between independent and
dependent variables.

MAJOR CONCEPTS OF EXPERIMENTAL DESIGN

1. Manipulation
Refers to the process by which the researcher manages the
independent variable in order to study the effect on the dependent variable.
It means that, within the specification of a given research design, the
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researcher actively initiates, implements and terminates procedures.
Essential to manipulation is that the researcher has complete control over
the process. The researcher decides what is to be manipulated (eg., selected
nursing intervention protocols), to who the manipulation applies (eg.,
samples and subsamples of subjects), when the manipulation is to occur
according to the specification of the research design and how the
manipulation is to be implemented.
Example
Gentle massage is effective as a pain relief measure for elderly nursing
home residents
The Independent variable is gentle massage which could be
manipulated by giving some patients the massage intervention and
withholding it for others
Then it is possible to compare the pain level (dependent variable) in
the two group to see if differences in receipt of the intervention
resulted in degree of pain levels
2. Control
The extent to which the researcher can manage extraneous sources that
might affect a study and lead to incorrect scientific conclusions. The
experiment must be organized so that the extraneous factors are prevented
from operating and confusing the outcome which is to be appraised. Control
is acquired by manipulating, by randomizing, by careful preparation of the
experimental protocols and by the use of a comparison group or groups.
Control aims to rule out threats to valid inference. It also adds precision, the
ability to detect true effects of smaller magnitude. Control also pertains to
the ability to determine which units receive a particular treatment at a
particular time. Control can be determined by two processes. The first
process refers to the use of random methods to assign subjects to
treatments. The second process is that of structuring the assignment process
in such a way the extraneous variables are controlled.
For example, a researcher studying various protocols of discharge
planning and follow up of LBW infants may choose to randomly assign infants
to various protocols. However, if the researcher is concerned that such
factors as socioeconomic status or the availability of additional caretakers
beyond the mother (eg., father, grandparent) may affect infants health and
well being, the researcher may want to control for such factors. Three
approaches to ensure the active control over known extraneous forces are
blocking (the researcher an design a study in which the potentially
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confounding variables is incorporated into study design as an independent
variable), matching (the pairing of subjects in one group with those in
another group based on their similarity on one or more dimension, to
enhance the overall comparability of groups) and counterbalancing (the
process of systematically varying the order of presentation of stimuli or
treatments to control for ordering effects, especially in a crossover design.
Example
If a researcher wanted to supplement diet of the low birth baby with a
particular nutrient for 2 weeks, the weight gain at the end of 2 weeks
would tell us nothing about the treatment effectiveness
Suppose an average 1 kg. weight gain is noted does this gain support
the conclusion that nutrition supplement (IV) caused the weight gain
(DV)
The answer will be NO? because babies normally gain weight as they
mature
Without a control group- a group that does not receive the nutritional
supplements it is impossible to separate the effects of maturation from
those treatments.
Therefore the term CONTROL GROUP refers to a group of
subjects whose performance on a dependent variable is used to
evaluate the performance of the experimental group on the same
dependent variable
3. Randomization
The term random essentially means that every subject has an equal
chance of being assigned to any group. Randomization is the process that
first ensures every unit in the target population has an equal chance of being
chosen for the study sample, and then ensures that each unit in the study
sample has on equal chance of being assigned to either the experimental or
the control group. The major concept, randomization entails two separate
processes: random selection of subjects from the population and random
assignment of subjects to treatment and control conditions. In both
processes, randomization provides a way to ensure that characteristics of
subjects are dispersed across sample and/or subsamples in a non systematic
fashion. This way, if any of these characteristics has extraneous or
confounding effects, the likelihood of such effect occurring is dispersed in a
probabilistically equal way.
Random selection: Refers to the process of randomly drawing

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research subjects from the target population, about which the researcher
wants to gain knowledge and to which the researcher hopes to generalize
the findings of a study. Random assignment: It entails allocating sampling
units to treatment and control conditions in a nonsystematic way, using a
decision method that is known to be random (eg., coin toss, random drawing,
use of random tables, computer-generated random sequences of options).
Example
The effectiveness of a contraceptive health education programme for
multiparous women. Two groups of subjects were included .One group was
given intervention and other was not. The women in the sample are likely to
differ in age, education, and attitude. This would affect the woman's
diligence in practicing contraception

MAJOR STEPS IN EXPERIMENTAL DESIGN

1. Delineate the population or universe to be studied (i.e. the set of subjects

or objects that share a common observable characteristic)
2. Select a sample from the population by random sampling method
3. By random assignment, sub-divide the sample into two sub-samples
4. Specify one sub-sample, the experimental group and other the control
group
5. Before introducing the independent variable, observe and record all
important characteristics of the two groups
6. Introduce the independent variable into the experimental group but
withholds it from the control group
7. After introducing the independent variable, observe the dependent
variable in both experimental and control group
8. Compare the changes that occur in the experimental group with those
that may have occurred in the control group
9. Record the difference between the groups
10. Compare these values with statistically computed values that judge
the significance of the difference, and indicate whether or not the
observed differences could have occurred by chance.

TYPES OF EXPERIMENTAL DESIGN

The investigator planning an experiment has many experimental

design option to choose. Experimental designs fall into three major
categories.

EXPERIMENTAL DESIGN
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 True experimental Quasi experimental
Pre-experimental design
design design
1. Pretest posttest 1. Non equivalent 1. 1. One shot case design
control group design control group design2. 2. One-group pretest
2. After/ posttest only 2. Time series designs posttest design
experimental design
3. Solomon four group
design
4. Factorial design
5. Randomized block
design
6. Cross over design.

I. TRUE OR CLASSICAL EXPERIMENTAL DESIGN

True experimental design is considered to be the classic form of

research, and experiments have the potential to provide the most evidence
for the strength of the association between variables. Experiments are
concerned with testing hypotheses and establishing causality.

Characteristics
A true experimental design is characterized by (already discussed n
detail)
1. Manipulation
2. Control
3. Randomization
Which means,
Obtain true representation of the cause and effect.
When greatest amount of control is required with least possible
error.
Eliminate all factors influencing the dependent variable other
than the independent variable under study.
Prevent other element to introduce during observation of the
specific cause and the effect under study.

Types
True or classical experimental design includes six major designs. They
are
1. Pretest posttest control group design
2. After/ post - test only experimental design
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 3. Solomon four group design
4. Factorial design
5. Randomized block design
6. Cross over design or repeated measures design.

The most commonly used in nursing studies, are discussed as

nomenclature used and definitions developed by Campbell and Stanley
(1963). The standard notations that are helpful in understanding alternative
experimental design are
X - To denote the experimental manipulation. (Treatment or
intervention)
O - To denote observations or measurement
R - To denote randomization

1. PRETEST AND POSTTEST DESIGN

Data collection both before and after the intervention; appropriate for
measuring change; can determine differences between groups
(experimental) and change within Groups. The initial measure of the
dependent variable is often referred to as the baseline measure and the
posttest measure of the dependent variable may be referred to as the
outcome measurethat is, the measure that captures the outcome of the
experimental intervention.
In the pretest posttest design subjects are randomly assigned to the
control and experimental group. Each group observed (pretest),
experimental group receives treatment, while the control group does not.
The researcher then observes the groups again (posttest) to determine the
effect of treatment.
Example
Effects of breathing exercise on stress among old age people

E - R O1 X O2

C - R O1 - O2

Advantages:
It decreases threats to internal validity such as history, maturation,
testing, statistical regression, selection and interactions with selection
Well designed experiment the only differences between the control and
experimental groups should be the treatment, whatever extraneous
events that between one observation and the next observation should
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 happen to both the control and treatment groups. Therefore the threat
of history can be reduced significantly.
Depending n the length of the intervention there may be some
maturation in the group over time, however with randomization and
use of a control group, it is possible to determine the changes in both
samples that can be attributed to maturation overtime and not to the
treatment.
The effects of testing are minimized when each group the pretest. If
the pretest does in some way influence the posttest, each group will be
similarly affected, which diminishes the effect.
The threat of statistical regression is minimized because extremes in
testing would not generally occur in only one group. The use of random
selection and random assignment can control for the bias of selection
and strengthen the internal and external validity of the study.

Disadvantages:
Mortality may affect one group more than the other. This attrition may
be unavoidable and may skew the study results.
The results can only be generalized to similar groups and settings.

2. AFTER ONLY OR POSTTEST ONLY DESIGN

After-only design or a posttest-only design, there is no pretest.
This design is particularly useful in situations in which it is not possible to
obtain a pretest measure. This design is composed of two randomly assigned
groups, the intervention has been introduced to the experimental group and
withheld from control group. Data on dependent variable are collected only
onceafter intervention.

Example
Effectiveness of antenatal nutrition education on pregnancy and labor
outcome among primipara mothers attending outpatient department

E - R X O1
C - R - O2

Advantages
It controls for many of the same threats to internal validity as
discussed in pretest and posttest design.

18
 The effect of testing would be eliminated because of the lack of
pretest.

Disadvantages
Randomization to the groups does provide some control, but without
pretest measures the researcher is less able to determine the strength
and direction of the response.

3. SOLOMON FOUR-GROUP DESIGN

When data are collected both before and after an intervention, as in a

pretestposttest design, the posttest measure of the dependent variable
may be affected not only by the treatment but also by exposure to the
pretest. Solomon four group design is designed to control the testing effect.
A combination of pretest posttest design and posttest only design in their
simplest form is called Solomon four group design. In Solomon four group
design, there are two experimental groups and two control groups. Subjects
are randomly assigned to one of the groups. Both the experimental group
receives the same treatment. Only one among the experimental and control
groups are pretested whereas all the four groups are posttested. The effect
of the treatment are determined by comparing the posttest scores of the
experimental and control groups.

Example
Effectiveness of workshop on management of HIV to improve the nurses
attitude toward patients with AIDS admitted in selected hospitals
A pretest attitudinal measure may in itself constitute a sensitizing
treatment that could mask the workshops effectiveness. Such a situation
calls for the Solomon four-group design, which involves two experimental
groups and two control groups. One experimental group and one control
group are administered the pretest and the other groups are not, thereby
allowing the effects of the pretest measure and intervention to be
segregated.

E - R O1 X O2

C - R O1 - O2

19
 E - R X O1

C - R - O1

Advantages:
It is a very strong design and greatly increases the level of internal
validity that can be achieved.
The effects of history and maturation are controlled for by the
pretested groups.
Groups without pretest control for the effect of testing.
Also the non pretested control group allows the researcher to assess
the impact of maturation without treatment.

Disadvantages:
Need increased resources to conduct the study correctly.
The design require a large number of samples who are available at the
same time. So that the design my require multiple researchers and
potential for increased observational bias

4. FACTORIAL DESIGN
The designs discussed so far have involved the manipulation of one
independent variable. At times a researcher may want to study the effect of
one or more independent variables. A factorial design is particularly useful
when there are multiple independent variables, which are called factors, to
be tested. Typical factorial designs incorporate 2 X 2 factorial or 2 X 3
factorial. The first number refers to the independent variables and the
second number to the levels of treatment. For example types of stimulation
can be factors (independent variables), and amount of daily exposure
(15mts, 30mts & 45mts) can be levels of treatment.
In this design testing of multiple hypotheses is done in a single
experiment. In factorial experiments subjects are assigned at random a
specific combination of conditions. Factorial design permit us to evaluate not
only main effects (effects resulting from experimentally manipulated
variables) but also interaction effects (effects resulting from combining
treatments).

Example
Two therapeutic strategies for premature infants: tactile stimulation
versus auditory stimulation. At the same time, we are interested in learning if
the daily amount of stimulation (15, 30, or 45 minutes) affects infants
progress. The dependent variables for the study are measures of infant
development (e.g., weight gain and cardiac responsiveness)
20
 Auditory Tactile
A1 A2
15 minutes
A1 B1 A2 B1
B1
30 minutes
A1 B2 A2 B2
B2
45 minutes
A1 B3 A2 B3
B3

Advantages:
The factorial design has the ability to test multiple independent
factors. This is particularly useful when levels of interventions are
being assessed.
Disadvantages:
This design require increased number of subjects to obtain statistical
significance.

5. RANDOMIZED BLOCK DESIGN

A specific type of factorial design is the randomized block design.
There may be factors that cannot be manipulated or the researcher suspects
may be confounding variables. Variables such as age, gender, race,
geographic location or hospital unit of the subject cannot be changed, that
may be confounding variables. To control for this problem the researcher can
design a study in which the potentially confounding variable is incorporated
into the study design as an independent variable, this is known as blocking.
Subjects are then randomly assigned within each block.

Example
Compare the effects of tactile versus auditory stimulation for female vs
male infants. It can be structured as 2x2 experiment, with type of stimulation
as one factor and gender as the other factor. The variable gender, which we
cannot manipulate, is known as a blocking variable

21
Advantages:
This design has the ability to test multiple independent factors
Confounding variables can be controlled in the study.
Disadvantages:
This design requires a large number of subjects
It is necessary to have equal numbers of subjects with the blocking
variable.

6. CROSS OVER DESIGN (OR REPEATED MEASURES DESIGN)

It involves the exposure of the same subjects to more than one

experimental treatment (within-subjects design), where subjects are
randomly assigned to different orders of treatment. Though crossover
designs is considered as an extremely powerful design, sometimes it is not
effective because of the problem of carry-over effects. When subjects are
exposed to two different treatments or conditions, they may be influenced in
the second condition by their experience in the first condition. As one
example, drug studies rarely use a crossover design because drug B
administered after drug A is not necessarily the same treatment as drug B
administered before drug A. cross over designs usually involve treatments
administered in a time sequence. Crossover designs can, however involve
simultaneous tests on two sides of a persons body.

Example
When we are comparing the effectiveness of the chlorhexidine and saline
mouth care protocol, first we administer the chlorhexidine mouth care
protocol on group I and saline mouth care protocol on the subjects of group
II. Later, the treatment is swapped, where group I receives the saline mouth
care and group II receives chlorhexidine. In such studies, subjects serve as
22
their own control.

Groups Protocols of the mouth care

Group I Chlorhexidine (1) Saline (2)
Group II Saline (2) Chlorhexidine (1)

Advantages:

1. It is more efficient in establishing the highest possible similarity among

participants exposed to different conditions, where groups being
compared obviously have equal distribution of same characteristics.

Disadvantages:
1. Sometimes it is not effective because of the problem of carry-over
effects. When subjects are exposed to two different treatments or
conditions, they may be influenced in the second condition by their
experience in the first condition.

ADVANTAGES OF TRUE EXPERIMENTAL DESIGN

1. True experiments are the most powerful method for testing hypothesis of
cause and effect relationship between variable because of the rigours,
precision and control properties of experimental design.
2. This if then type of relationship is important to nursing and medical
researchers because of its implications for prediction and explanation.
3. Though the control imposed by manipulation comparison and
randomization, alternative explanation to a cause interpretation can be
ruled out or discredited.
4. In these studies, the controlled environment in which study is conducted
can yield a greater degree of purity in observation

DISADVANTAGES OF TRUE EXPERIMENTAL DESIGN

1. Some variables are not feasible or ethical to manipulate e.g., assessing

pregnant women to take a new drug found to be dangerous to fetal
development would not be ethically possible.
2. Randomization and otherwise equal treatment of control and
experimental group can occur in a laboratory, but these conditions do not
resemble what goes under real world conditions, and experimental
findings can therefore be based on rather artificial circumstance
3. Experimental design attempt to reduce variable to measurable terms.
Many of the phenomena that are important to science in nursing are
23
 complex, multidimensional and holistic, and the reductionism that has
worked reasonably in the physical or natural sciences.

II. QUASI EXPERIMENTAL DESIGN

True experimental design is considered to provide the strongest

evidence for assessing causality between the independent and dependent
variables. However, when conducting research in field settings, it is not
always possible to implement a design that meets the three criteria of an
experimental study: manipulation, control and randomization. Quasi
experimental research design in which the researcher initiates an
experimental treatment but some characteristics of a true experiment is
lacking.

DEFINITION
Quasi experiments involve the manipulation of an independent
variable, but they lack either randomization or control group.

PURPOSES
1. To provide alternative means of examining causality in situations not
conducive to experimental group.
2. To facilitate the search for knowledge and examination of causality in
situations in which complete control is not possible.

TYPES OF QUASI EXPERIMENTAL DESIGN

1. Non equivalent control group design

2. Time series designs

1. NONEQUIVALENT CONTROL GROUP DESIGNS

The most frequently used quasi-experimental design is the
nonequivalent control group pretest posttest design. It is often used when
there are naturally occurring groups of subjects or when it is impossible or
unethical to withhold treatment from one group (ie., experimental and
control group from different setting)
In this design, experimental and control groups are selected without
randomization and dependent variables are observed in experimental as well
as control groups before the intervention. Later, the experimental group
receives the treatment and after that posttest observation of dependent
variables is carried out for both the groups to assess the effect of treatment
on experimental group.

Example
24
 Effect of introducing primary nursing on staff morale in a large metropolitan
hospital. Because the new system of nursing care delivery is being
implemented throughout the hospital, randomization is not another similar
hospital that is not instituting primary nursing. Data on staff morale is
collected in both hospitals before the change is made (the pretest) and again
after the new system is implemented in the first hospital (the posttest).The
design is the weaker of the two because it can no longer be assumed that
the experimental and comparison groups are equivalent at the outset
E - O1 X O2

C - O1 - O2 (different settings)

Advantages:
When subjects from different settings are used, a nonequivalent
control group design may control some threats to internal validity.
When subjects naturally kept separate, it is likely to minimize contact
between experimental and control groups.

Disadvantages:
This design is weaker because it cannot be assumed that the
experimental and control groups are equivalent.
It is impossible to ensure that events between the pretest and the
posttest are identical for the two settings.
Subjects are not randomly selected for the study.
The generalizability of the study findings is limited.

2. TIME SERIES DESIGNS

Time series design, sometimes referred to as the interrupted time
series design. The basic notion underlying the time series design is the
collection of information over an extended period and the introduction of an
experimental treatment during the course of the data collection period
(several pretest observations are made, the treatment is administered and
several posttest observations are made).
In this time series designs the researcher does not always use a control
group and does not use randomization. When the researcher studies one
group of subjects, the subjects act as their own controls, which provides the
researcher with equivalent control groups. Time series designs are used
when a control group is not available.

Example

25
 Effect of an integrated point-of case computer system on the quality of
nurses documentation. Measurements of the quality of documentation were
made before the intervention was implemented, and again at 6-, 12-, and 18-
months after implementation. The researchers found that quality of nursing
documentation increased, and variability in charting decreased.

E - O1 O2 O3 O4 X O5 O6 O7 O8

Advantages:
Repeated pretest observations help to control for maturation.
Repeated posttest measures allow the researcher to determine if post
treatment changes are maintained over time.
Increasing frequency of observations and recording any significant
events during the study period will help to determine the effect outside
events may have had on the outcome.
Disadvantages:
Subjects are not randomly selected for the study.
With repeated observations instrumentation is threat to validity.
Selection becomes a threat when some subjects drop out of treatment
at the time the treatment is administered.

ADVANTAGES OF QUASI EXPERIMENTAL DESIGN

More frequently used because they are more practical and feasible to
conduct research studies
More suitable for real-world natural setting
DISADVANTAGES OF QUASI EXPERIMENTAL DESIGN
It cannot test causal hypothesis
There is no control over extraneous variable
Less external generalizability and less reliable

III. PREEXPERIMENTAL DESIGN

This research design is considered very weak, because the researcher
has very little control over the experiment.

TYPES OF PREEXPERIMENTAL DESIGN

1. One shot case design

2. One-group pretestposttest design

1. ONE SHOT CASE DESIGN

26
 In this research design, a single experimental group is exposed to a
treatment and observations are made after the implementation of that
treatment. There is no random assignment of subjects to the experimental
group and no control group at all. This design is simple & quick, minimizes
the threat of testing and possible increased cooperation of subjects
Example
Effect of sucrose water on pain during immunization among newborns.

E - X O2

2. ONE-GROUP PRETESTPOSTTEST DESIGN

This one-group pretestposttest design seems straightforward, but it
has weaknesses. This design has no control group and no randomization.
The experimental group is selected without randomization, a pretest
observation of the dependent variable is made before implementation of the
treatment to the selected group, the treatment is administered and finally a
posttest observation of dependent variables is carried out to assess the
effect of treatment of the group.

Example
Effect of relaxation therapy on hypertension among hypertensive
patients.

E - O1 X O2

ADVANTAGES OF PREEXPERIMENTAL DESIGN

Very simple and convenient to conduct studies in natural settings
Most suitable design for beginners in the field of experimental research

DISADVANTAGES OF PREEXPERIMENTAL DESIGN

Considered very weak experimental design to establish causal
relationship between dependent & independent variables
It has very little control over research
It has higher threat to internal validity

NON EXPERIMENTAL DESIGN

Non experimental research is important because there are situations in

which an experimental or quasi experimental design is inappropriate for a
particular research question. Manipulation of variables is not always possible,
27
especially for variables like sex, age or diagnostic category. Randomization is
not always ethical, because with human subjects it may be impossible to
randomly assign subjects to groups. Randomization is especially problematic
in situations in which the experimental treatment is known to provide some
benefit. To withhold treatment and assign some subjects to a control group
would be unethical. Non experimental research, the researchers collect data
without making changes or introducing treatments. Data obtained are
analyzed and the results may lead to the formation of hypothesis that can
then be tested experimentally.

DEFINITION

Non experimental research designs are those that do not involve

manipulation of an independent variable, control or randomization, in which
the researchers observes the phenomena as they occur naturally.

GOAL OF NON EXPERIMENTAL RESEARCH

To describe phenomena and explore and explain the relationship

between variables.

NEED FOR NON EXPERIMENTAL RESEARCH

1. Human characteristics not subject to experimental manipulation.

2. Many variables cant be manipulated ethically.
3. Where experimental method not practical.
4. When research questions cannot be addressed with an experimental
design.
5. To form a basis for experimental study before conducting an
experimental
research.

TYPES OF NON EXPERIMENTAL RESEARCH DESIGNS

28
 Non experimental research designs

1. Descriptive design
Univariate descriptive design

Exploratory descriptive design

Comparative descriptive design

2. Correlational/Ex-post facto design

Prospective design

Retrospective design

3. Developmental research design

Cross sectional design

Longitudinal design

4. Epidemiological design
Case control studies

Cohort studies

5. Survey research design

6. Natural experiment

I. DESCRIPTIVE DESIGN
Descriptive study is one form of observational study, which collects
analyses and presents data on a specific topic. The key features of
descriptive study are the absence of a comparison group and non
intervention. The purpose of descriptive studies is to observe, describe, and
document aspects of a situation as it naturally occurs and sometimes to
serve as a starting point for hypothesis generation or theory development.
Although descriptive design is weak design, it is frequently used when very
little is known about a topic or to initially explore a research question.

Main features of descriptive design

29
 They are designed to gain more information about characteristics
within a particular field of enquiry.
It is used for the purpose of developing theory.
Identifies problems in the current practice or makes judgement of the
practice.
Descriptive designs vary in levels of complexity.
Some contain only two variables others may include multiple variables.
Greater protection against bias is required in descriptive design.
Types of descriptive design

Univariate descriptive design

Exploratory descriptive design
Comparative descriptive design
a. Univariate descriptive design
Univariate descriptive studies are undertaken to describe the
frequency of occurrence of a phenomenon or behavior or condition rather
than to study relationships. For example, an investigator may wish to
describe the health care and nutritional practices of pregnant teenagers.
Univariate descriptive studies are not necessarily focused on only one
variable, there may be one or more variables involved in the study. For
example, a researcher might be interested in womens experiences during
menopause. The study might describe the frequency of various symptoms,
the average age at menopause, the percentage of women seeking formal
health care, and the percentage of women using medications to alleviate
symptoms. There are multiple variables in this study, but the primary
purpose is to describe the status of each and not to relate them to one
another.

There are two types of descriptive studies in the field of epidemiology

namely; Prevalence studies are done to determine the prevalence rate of
some condition (e.g., a disease or a behavior, such as smoking) at a
particular point in time. Prevalence studies rely on cross sectional designs in
which data are obtained from the population at risk of the condition. The
researcher takes a snapshot of the population at risk to determine the
extent to which the condition of interest is present.

The formula for a point prevalence rate (PR) is:

30
 Number of cases with the condition
or disease at a given point in time X 100
Number in the population at risk of being a case
At the same point of time
Incidence studies are used to measure the frequency of developing
new cases. Longitudinal designs are needed to determine incidence because
the researcher must first establish who is at risk of becoming a new case
that is, who is free of the condition at the outset. The formula for an
incidence rate (IR) is:
Number of new cases with the condition
or disease over a given time period X 1000

Number at risk of becoming a new case

(free of the condition at the outset)

b. Exploratory descriptive design

Exploratory design is used to identify, explore and describe the existing
phenomenon and its related factors. It is not only a simple description or the
frequency of occurrence of a phenomenon, but its indepth exploration and
study of its related factors to improve further understanding about a less
understood phenomenon, basic knowledge, clarify relevant issues, uncover
variables associated with a problem, uncover information needs, and/or
define alternatives for addressing research objectives.

Example: An exploratory study to assess the multifactorial dimensions of

falls and home safety measures for elderly people living in selected
communities in the Kollam district.

c. Comparative descriptive design

Comparative design involves comparison of two or more groups. This
design is used to compare two distinct groups on the basis of selected
attributes such as knowledge level, perceptions and attitudes; physical or
psychological symptoms and so on. Information is obtained on each group
and using statistical analysis, the researcher tries to identify what differences
exist between the groups. When conducting a comparative study, it is
important for the study samples to be as similar as possible in all variables
except the variable under study. This design can provide detailed information
about several groups but it has the weakness, inability to determine the
degree of association between variables.

31
 Example: A comparative study on health problems among rural &
urban older people in Kollam district.

II. CORRELATIONAL/EX-POST FACTO DESIGN

The ex-post facto design or after the fact designs are frequently
referred to as correlational studies. In ex-post facto research there is no
manipulation in the independent variable, because the event of interest
(dependent variable) has already occurred. This type of research is
conducted to describe existing relationships between variables and to
determine if there is a correlation between variables. When a correlation
exists, a change in one variable corresponds to a change in other variables.
However, it must be kept in mind that a correlation does not indicate
causation.

Types of correlational research design

Prospective research design

Retrospective research design
a. Prospective research design
A design in which the researcher relates the present to the future is a
prospective research design. Prospective studies start with a presumed
cause and then go to the presumed effects. In this design researcher selects
a population and follows it over time to determine outcomes. Prospective
studies are frequently used in epidemiological research as cohort studies to
determine what effect exposure to certain risk factors has on the
development of disease.

Example: A prospective study to assess the effect of rubella infection

during pregnancy on birth outcome among women.

Advantages:

This design provides more convincing evidence of the nature of the

relationship between variables.
The results obtained from prospective studies may provide essential
preliminary research to generate hypothesis that can be tested with
other experimental or quasi experimental methods.
It is easier to determine the sequencing of events over time, which
makes prospective studies more useful in determining temporal
antecedence.

32
 Disadvantages:

They are time consuming and expensive and require large number of
samples.
This studies cannot be used to infer causality.

b. Retrospective research design

A design in which a phenomenon existing in the present is linked to
phenomena that occurred in the past. When using a retrospective design the
researcher starts with an effect and works back to determine what is the past
is associated with this effect. For example, subjects are chosen based on
disease status and information about the past history is then obtained to
determine what may have contributed to the development of a specific
disease. Most of the early epidemiologic studies of the link between cigarette
smoking and lung cancer were retrospective.

Example: A retrospective study to identify the antecedent factors to

predict depressive symptoms in grandmothers.

Advantages:

This studies are particularly useful when investigating rare occurrences

This studies can utilize existing data and therefore may be faster and
less expensive.
Disadvantages:

Subjects may have recall bias in which they are more aware of their
personal history and over report events.
Over reporting may lead the researcher to conclude that a stronger
association exists than actually does exist.
Causation cannot be inferred, that is, when one vent precedes another
in time, does not automatically indicate that one event caused the
other.

III. DEVELOPMENTAL RESEARCH DESIGN

Research design that is concerned not only with the existing status &
interrelationships of phenomena but also to examine the way variables
change over time.

33
 Types of developmental research design

Longitudinal design
Cross-sectional design
a. Longitudinal design
Longitudinal study allows the researcher to collect the data at more
than one point in time over an extended period. Its value is in its ability to
demonstrate change over a period f time. Three of the more commonly used
longitudinal designs are trend studies, cohort studies and panel studies.
Example: A study to assess the perception of nursing students towards
nursing profession from the beginning to its end.

Trend studies: The researcher selects the samples from the general
population at specified time intervals and at each interval new subjects are
chosen. Example: Alcohol consumption over a period of 10 years.

Cohort studies: Different subjects are also selected at specified time

intervals, however, these subjects are drawn from previously identifies
groups within the population

Panel studies: It involves the repeated measurement of the same subjects

at specified time intervals. Example: Explorative study of relationship
between paternal-and maternal-fetal attachment and infant temperament.

Follow-up studies are similar to panel studies, but are usually undertaken
to determine the subsequent development of individuals who have a
specified condition or who have received a specified interventionunlike
panel studies, which have samples drawn from more general populations. For
example, patients who have received a particular nursing intervention or
clinical treatment may be followed to ascertain the long-term effects of the
treatment. As another example, samples of premature infants may be
followed to assess their later perceptual and motor development.

Advantages

Subjects are studied for changes over time.

34
 Gives detailed information on specific individuals and changes that
occur with these individuals over time.

Disadvantages

Very lengthy and expensive.

There is often a bias in selection of subjects.
Mortality (loss of subjects) can be high.

b. Cross sectional Designs

Cross-sectional designs involve the collection of data at one point in
time or the phenomena under study are captured during one period of data
collection. Cross-sectional studies are appropriate for describing the status of
phenomena or for describing relationships among phenomena at a fixed
point in time.

Example: A study to assess the sleep pattern and the prevalence of

sleep disorders during pregnancy.

Advantages:

Can be completed in a relatively short time.

Less expensive
Sample loss is less than longitudinal study.
Results are known early.
Disadvantages:

Difficult to determine what contributed to any observed differences in

the data.
There may be generational differences between groups rather than
changes that occur over time.

IV. EPIDEMIOLOGICAL DESIGN

35
 Epidemiology is the study to investigate the distribution and causes of
the diseases in population. Therefore, epidemiological studies are generally
conducted to investigate causes of different diseases in either prospective
approaches (cause to effect) or retrospective approaches (effect to cause).
However in epidemiology different terminology is used for prospective and
retrospective designs. Prospective studies are known as cohort studies and
retrospective studies are called case control studies.

a. Cohort Study
Cohort studies are a particular kind of trend study in which specific
subpopulations are examined over time. The samples are usually drawn from
specific age-related subgroups. For example, the cohort of women born from
1996 to 2000 may be studied at regular intervals with respect to health care
utilization

Features

The cohort are identified prior to the appearance of the disease

under investigation.
The study groups are observed over a period of time to
determine the frequency of disease among them.
The study proceeds forward from cause to effect.
Types of Cohort Study

a. Prospective cohort study is one in which the outcome (eg., disease)

has not yet occurred at the time the investigation begins. Most
prospective studies begin in the present and continue into future.

b. Retrospective cohort study is one in which the outcomes have all

occurred before the start of investigation. The investigator goes back in
time, sometimes 10 to 30 years, to select his study groups from existing
records of past employment, medical or other records and traces them
forward through time, from a past date fixed on the records, usually up to
the present.

c. A combination of prospective & retrospective cohort study both

the retrospective and prospective elements are combined.

36
 Elements of Cohort Study

Selection of study subject persons with different degrees of

exposure to the suspected causal factor
Obtaining data on exposure information about exposure may be
obtained directly from the study subjects, review of records, medical
examination or special tests and environmental surveys.
Selection of comparison groups -
Follow up regular follow up of all the participants
Analysis data are analyzed in terms of incident rate of outcome
among exposed & non exposed and estimation of risk.
Advantages:

Incidence can be calculated

Several possible outcomes related to exposure can be studied
simultaneously ie., we can study the association of the suspected
factor with many other diseases in addition to the one under study.
It provide a direct estimate of relative risk
Since comparison groups are formed before disease develops,
certain forms of bias can be minimized like mis-classification of
individuals into exposed and unexposed groups.
Disadvantages:

It needs a large number of people. It is unsuitable for investigating

uncommon diseases or diseases with low incidence in the
population.
It takes long time to complete the study and obtain results by which
the researcher may have died or participants may have change
their classification eg., CAD.
Certain administrative problems such as loss of experienced staff,
loss of funding and extensive record keeping are inevitable.
Cohort studies are expensive.

37
 Study itself alter the behaviour of the people, if we are examining
the role of smoking in lung cancer, may induce the study subjects to
stop or decrease smoking.
b. Case control design
It involves the comparison of cases (subjects with certain illness or
condition, such as lung cancer victims) with controls (people without lung
cancer). In conducting a strong casecontrol study, researchers find the
cases and obtain from them (or about them, if records are available)
information about the history of the presumed cause. Then the researchers
must find controls without the disease or condition who are as similar as
possible to the cases with regard to key extraneous variables (e.g., age,
gender) and also obtain historical information about the presumed cause. If
controls are well chosen, the only difference between them and the cases is
exposure to the presumed cause. Researchers sometimes use matching or
other techniques to control for extraneous variables. To the degree that
researchers can demonstrate comparability between cases and controls with
regard to extraneous traits, inferences regarding the presumed cause of the
disease are enhanced.

Case control studies have been used effectively for studies of many
cancers, and other serious conditions such as cirrhosis of liver, lupus
erythematosis and CCF. For example, to test the hypothesis that cigarette
smoking causes lung cancer, using case control method. The investigation
begins by assembling a group of lung cancer cases and a group of suitably
matched controls. Then explore the past history of these two groups for the
absence or presence of smoking, which is suspected to be related to the
occurrence of cancer lung. If the frequency of smoking is higher in cases
than in controls, an association is said to exist between smoking and lung
cancer.

Features of case control design

1. Both exposure and outcome (disease) have occurred before the start of
the study
2. The study proceeds backwards from effect to cause
3. It uses a control or comparison group to support or refute an inference
Steps of case control design

1. Selection of cases and controls: The first step is to identify a

suitable group of cases and a group of controls. While identification of
38
 cases is relatively easy, selection of suitable controls may present
difficulties.
Selection of case involves two specifications (i) Diagnostic criteria of
the disease and the stage of disease to be included in the study must
be specified before the study is undertaken. (ii) Eligibility criteria is the
requirement of new diagnosed (incident) cases within a specified
period of time are eligible than old cases or cases in advanced stages
of disease (prevalent cases). The sources of cases from hospital or
general population (within a defined geographic area during a specified
period of time.

Selection of controls must be similar to cases as possible, except

the absence of disease under study. The possible sources from which
controls may be selected include hospitals, relatives, neighbours and
general population. The number of controls must be equal to cases.

2. Matching: Matching is defined as the process by which we select

controls in such a way that they are similar to cases with regard to
certain pertinent selected variables (eg. Age) which are known to
influence the outcome of disease and which, if not adequately matched
for comparability, could distort or confound the results. While
matching, suspected etiological factor or variable we wish to measure
should not be matched, because by matching, its etiological role is
eliminated in that study.
3. Measurement of exposure: Information about exposure should be
obtained in precisely the same manner both for cases or controls. This
may be obtained by interviews, by questionnaires or by studying past
records of cases such as hospital records, employment records, etc.
4. Analysis: To find out (a) exposure rates among cases and controls to
suspected factor and (b) estimation of disease risk associated with
exposure (Odds ratio).
Advantages:

Relatively easy to carry out

Rapid and inexpensive
Required comparatively few subjects
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 Particularly suitable to investigate rare diseases or diseases about
which little is known.
No risks to subjects
Allows the study of several different etiological factors eg., smoking,
physical activity and personality characteristics etc.
Risk factors can be identified. Rational prevention and control
programmes can be established.
No attrition problems, because case control studies do not require
followup of individuals into the future.
Ethical problems minimal.
Disadvantages:

Problems of bias relies on memory or past records, the accuracy of

which ay be uncertain
Selection of an appropriate control group may be difficult
We cannot measure incidence, and can only estimate the relative risk
Do not distinguish between causes and associated factors.
Another major concern is the representativeness of cases and controls.

V. SURVEY RESEARCH DESIGN

According to Kerlinger

Survey research, studies large and small populations by research

selecting and studying samples chosen from the population to discover the
relative incidence, distribution and interrelations of sociological and
psychological variable.

A survey design which is used to collect information from different

subjects within a given population having same characteristics of interest. If
a survey is conducted on a sample of population, it is called sample survey
and if the entire population is involved, it is called a population survey, such
as census, etc.

Main features:

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 Survey is the process of gathering current required data from the
subjects so that new information can be obtained. It enables to collect
current information about whatever it is the investigator wish to study
Information is collected from a mix of subjects who represent the
population
It is a mode of enquiry that relies heavily upon the validity of verbal
responses
Survey can be descriptive, exploratory, comparative and correlational
depending upon the nature of phenomenon studied
Survey can be collected in number of ways. Most common method is
questioning self reporting or face to face interview. A carefully
developed questionnaire of interview schedule is required.
Personal interviews are regarded as the most useful method of
collecting survey data, because of the quality of information that can
be obtained.
An indepth response is possible in an interview as relatively few people
refuse to express their views on a given subject in an interview.
Types of surveys:

(a) Depending on the nature of phenomenon under study

Descriptive Survey It is undertaken the describe the frequency

of occurrence of a phenomenon rather than a study relations
Exploratory It is the survey of a phenomenon, and its related
factors, about which much is not known
Comparative Comparing and contrasting the existence of a
certain phenomenon in two or more groups is done by comparative
surveys
Correlational It is a study of the relationship between two or
more variables in a natural setting without manipulation or control
(b) Based on data Collection

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 Written survey Data are collected with the help of written,
structured tools, such as questionnaires, opinionnaires, etc.
Oral Survey Data is on oral survey is collected by using face to
face or telephonic conversation or oral interview with respondents
Electronic Survey When data is collected by using electronic
means such as electronic-mail messages (E-Mail), web forms,
mobile short message services (SMS), etc., It is known as electronic
survey
Advantages

Data gathered from natural setting.

Suitable to cover large population.
A large amount data collected at fairly low price.
Able to cover wide geographical area, reach many people, ensure
respondents anonymity and require less skill.
Careful instrument presentation and use of random sampling yield
considerable degree of representativeness
Variables are examined as they are found in the existing social milieu.
Disadvantages

Collect only self reports. They may not be willing to express attitudes
or beliefs on sensitive topics.
Standardization of questionnaire means that the least common
denominator is represented.
The respondents response rate may be low thereby introducing bias.
Unless the researcher uses the interview which is more expensive the
researcher is not able to observe the study subjects directly and losses
feel of the situation.

VI. NATURAL EXPERIMENTS

Researchers are able to study the outcomes of a natural experiment. A
group exposed to natural or other phenomena. The important health
consequences are compared with a non exposed group. The researcher does
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not intervene. Simply observes the outcome of an external event. (e.g)
Health status or psychological well being of the people exposed to Tsunami
could be compared. With the well being of people living in a similar but
unaffected community. This determines the impact of the disaster
(Independent variable). Equivalence of groups is important.

ADVANTAGES OF NON EXPERIMENTAL DESIGN

1. Non experimental designs tend to be closest to real life situations.

These research designs are extremely useful to enhance our
understanding about the existing real world settings around us.
2. Non experimental designs are most suitable for the nursing research
studies.
3. Numerous human characteristics are inherently not subject to
experimental manipulation eg., blood type, personality, health
beliefs etc., therefore the effects of these characteristics on other
phenomena cannot be studied experimentally.

DISADVANTAGES OF NON EXPERIMENTAL DESIGN

1. The results obtained and the relationship between the dependent

and independent variables can never be absolutely clear and error
free.
2. Non experimental studies are conducted for comparative purposes
using non randomly selected groups, which may not be
homogenous and tend to be dissimilar in different traits,
characteristics, which may affect the authenticity and
generalizability of the study results.

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RESEARCH DESIGN

Notes prepared by
K. Shakila

Vice Principal

Vijaya College of Nursing

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Kottarakkara

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