RESEARCH METHODOLOGY

INTRODUCTION

Dr Urmila M. Aswar,
Professor,
PhD Pharmacology,
9/8/2024 PCP, Pune 1
 Research definition
Research refers to a search for knowledge.
Defined as a scientific and systematic search for pertinent
information on a specific topic.
Research is an art of scientific investigation.
The Advanced Learner’s Dictionary of Current English lays down the
meaning of research as “a careful investigation or inquiry specially
through search for new facts in any branch of knowledge.”
Redman and Mory define research as a “systematized effort to gain
new knowledge.”

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 Research, an academic activity
Research is an academic activity and as such the term should be
used in a technical sense. According to Clifford Woody research
comprises defining and redefining problems, formulating
hypothesis or suggested solutions; collecting, organising and
evaluating data; making deductions and reaching conclusions;
and at last carefully testing the conclusions to determine whether
they fit the formulating hypothesis.
The purpose of research is to discover answers to questions
through the application of scientific procedures.

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 OBJECTIVES OF RESEARCH
• The main aim of research is to find out the truth which is hidden and which has not
been discovered as yet.
• Though each research study has its own specific purpose, we may think of research
objectives as falling into a number of following broad groupings:
• 1. To gain familiarity with a phenomenon or to achieve new insights into it (studies
with this object in view are termed as exploratory or formulative research studies);
• 2. To portray accurately the characteristics of a particular individual, situation or a
group (studies with this object in view are known as descriptive research studies);
• 3. To determine the frequency with which something occurs or with which it is
associated with something else (studies with this object in view are known as
diagnostic research studies);
• 4. To test a hypothesis of a causal relationship between variables (such studies are
known as hypothesis-testing research studies).
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 Motivation
1. Desire to get a research degree along with its consequential
benefits;
2. Desire to face the challenge in solving the unsolved problems,
i.e., concern over practical problems initiates research;
3. Desire to get intellectual joy of doing some creative work;
4. Desire to be of service to society;
5. Desire to get respectability

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 Types of Research
• Classification-
• Descriptive
• Analytical
• Basic/ Fundamental
• Applied
• Conceptual
• Qualitative
• Quantitative

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 TYPES OF RESEARCH
• Descriptive and Analytical
• Descriptive research includes surveys and fact-finding
enquiries of different kinds.
• Ex post facto research
• The main characteristic of this method is that the researcher
has no control over the variables; he can only report what has
happened or what is happening.

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• for example, frequency of shopping, preferences of people, or
similar data. Ex post facto studies also include attempts by
researchers to discover causes even when they cannot control
the variables. The methods of research utilized in descriptive
research are survey methods of all kinds, including
comparative and correlational methods.

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 Analytical research
• In analytical research, on the other hand, the researcher has to use
facts or information already available, and analyze these to make a
critical evaluation of the material.

• Descriptive research classifies, describes, compares, and

measures data.
• While, analytical research focuses on cause and effect.

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 Descriptive vs Analytical
Descriptive Analytical

How many disabled people What causes social isolation in

face social isolation? disabled people?

What is the unemployment rate for Why do disabled people have a

disabled people? harder time finding work?
Positive attitudes prevail within families of people with
Down syndrome
How many siblings of people with Why do so many siblings of people
Family members share feelings of love and pride, few report regret or
Down syndrome have positive with Down syndrome have positive
embarrassment
Date:
experiences? experiences?
March 8, 2016
Source:
Massachusetts General Hospital
Summary:
Within most families, the experience of having a member with Down syndrome is generally a positive
one, new research concludes. Investigators evaluated surveys of more than 2,000 parents or
guardians of individuals with Down syndrome; more than 800 siblings of someone with Down
syndrome, and 248 people with Down syndrome.

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 Fundamental vs Applied
• Research can either be applied (or action) research or
fundamental (to basic or pure) research.
• Fundamental/ Basic research is mainly concerned with
generalisations and with the formulation of a theory. Research
concerning some natural phenomenon or relating to pure
mathematics are examples of fundamental research
1.An investigation into the symptoms of Coronavirus.
2.An investigation into the causative factors of malaria
3.An investigation into the secondary symptoms of high blood pressure.

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 Fundamental/ Basic research
1.Basic research is analytical in nature.
2.It aims at theorizing concepts and not solving specific
problems.
3.It is primarily concerned with the expansion of knowledge and
not with the applicability of the research outcomes.
4.Basic research is explanatory in nature.
5.It improves the general knowledge and understanding of
different fields of study.
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 Applied research
• Applied research aims at finding a solution for an immediate
problem facing a society or an industrial/business organisation.
• It is often called a “scientific process” because it uses the
available scientific tools and puts them to use to find answers.
• Evaluation research,
• Research and Development, and
• Action research.

Eg. Trying to find a cure for obsessive-compulsive disorder.

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 Conceptual research
• Conceptual research is that related to some
abstract idea(s) or theory. It is generally used by
philosophers and thinkers to develop new
concepts or to reinterpret existing ones.
• It is data-based research, coming up with
conclusions which are capable of being verified by
observation or experiment.
• Create modern speculations or decipher existing
hypotheses
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 Quantitative vs. Qualitative:
Quantitative research is based on the measurement of quantity
or amount. It is applicable to phenomena that can be
expressed in terms of quantity.
Qualitative research, on the other hand, is concerned with
qualitative phenomenon, i.e., phenomena relating to or
involving quality or kind.

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 Research Approaches

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 Qualitative Research

• ‘Qualitative Research…involves finding out what people think, and how

they feel - or at any rate, what they say they think and how they say
they feel. This kind of information is subjective. It involves feelings and
impressions, rather than numbers’

• Kaplan and Maxwell (1994) argue that the goal of understanding a

phenomenon from the point of view of the participants and its particular
social and institutional context is largely lost when textual data are
quantified.

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 Cont..
• It is a Phenomenological paradigm.
• The interpretation is done by the observer only
• Eg ethnographic studies, traditional studies, case study, participant
observational etc.

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 Qualitative research is

• Multimethod in focus, involving an interpretative, naturalistic approach

to its subject matter.
• Qualitative Researchers study “things” (people and their thoughts) in
their natural settings, attempting to make sense of, or interpret,
phenomena in terms of the meanings people bring to them.

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 • Qualitative research involves the studied use and collection
of a variety of empirical materials
➢ case study,
➢ personal experience,
➢ introspective,
➢ life story,
➢ interview,
➢ observational,
➢ historical, interactional, and visual texts-that describe routine and
problematic moments and meanings in individuals lives.
• Deploy a wide range of interconnected methods, hoping
always to get a better fix on the subject matter at hand.

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 QUALITATIVE RESEARCH METHODS

• Action Research- a teacher-researcher studying how their

teaching has changed in order to facilitate better discussions in the
classroom, and how these changes impact the students. Through
better discussions, students can develop a better understanding of the
content being covered in class.

• Case study-is an in-depth, detailed examination of a particular

case (or cases) within a real-world context

• Grounded Theory: continuous interplay between data

collection and analysis

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 QUALITATIVE RESEARCH METHODS
• In depth Interviewing
• Focus Groups - a small group of carefully selected participants Example attached as PDF
• narrative data on participants, insights, perceptions and attitudes.
• Participant Observations-research methodology where the researcher is immersed
in the day-to-day activities of the participants.
• EG. Participant observation can be a powerful tool for studying the complex social
interactions that occur within a particular group or community. By immersing yourself in the
group and observing these interactions firsthand, one can gain a much more nuanced
understanding of how these interactions flow.
• Ethnographic Studies- an anthropologist traveling to an island, living within the
society on said island for years, and researching its people and culture through a
process of sustained observation and participation.
• Projective Techniques-allow respondents to project their subjective or true opinions
and beliefs - unconscious motives and feelings.

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 Philosophical assumptions

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 Factors affecting
• Positivist: independent of the observer, the results are based on
reality.
• Interpretive: information, language, consciousness and shared
meanings
• Critical: Affected by various forms of social, cultural and
political domination.

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 Popularity of Qualitative Research
1 Usually much cheaper than quantitative research.

2 No better way than qualitative research to understand in-

depth the motivations and feelings of consumers.

3 Qualitative research can improve the efficiency and

effectiveness of quantitative research

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 Limitations of Qualitative Research
1 Marketing successes and failures are based on small differences in
the marketing mix. (4P’s- product, price, placement, and
promotion)
Qualitative research doesn’t distinguish these differences where
quantitative research can.

2 Not representative of the population that is of interest to the

researcher.

3 The multitude of individuals who, without formal training, profess

to be experts in the field.

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 Analysis Qualitative Data:
An Approach
• Categorisation

• Unitising data

• Recognising relationships and developing the categories we are

using to facilitate this

• Developing and testing hypotheses to reach conclusion

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 Interactive Nature of the Qualitative Process
• Data collection, data analysis, the development, verification of
relationships and conclusion are all interrelated and interactive set of
processes
• Allows researcher to recognise important themes, patterns and
relationships as they collect data
• Allows to re-categorise existing data to see whether themes and
patterns and relationships exist in the data already collected
• Allows to adjust future data collection approach to see whether they
exist in other cases

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Example- Subjects working in a company.
• Data Collected:
• Monthly productivity reports.
• Frequency and nature of communication with managers.
• Self-reported stress levels and job satisfaction.

• By analyzing the data, the researcher can recognize that:

• Important Themes: Work-life balance, isolation, and productivity fluctuations are critical themes.
• Patterns: Effective communication and flexible schedules impact productivity and well-being.
• Relationships: There's a relationship between communication frequency, stress levels, and productivity.

• Employees with flexible hours and a strong support system report higher productivity and better well-
being.

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 Tools for helping the Analytical Process
• Summaries
• Should contain the key points that emerge from undertaking the specific
activity
• Self Memos
• Allow one to make a record of the ideas which occur about any aspect
of your research, as one think of them
• Researcher Diary

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 Quantitative research
• Quantitative research is all about quantifying relationships
between variables. Variables are things like weight,
performance, time, and treatment.
• Measure variables on a sample of subjects, which can be
tissues, cells, animals, or humans.
• Statistical analysis is used to express the relationship between
the variables.

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 Example
Effect on BUN (mg/dl)

control Std T1 T2

H 15.60 16.35 30.80 21.04

B 16.20 21.00 30.20 16.30

T 18.60 23.80 33.17 17.70

HB 17.36 17.89 35.32 18.96

HT 17.84 18.60 30.45 20.22

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 Mean organ weight (mg) of rat

control Std T1 T2

Organ 1 4.00 11.0 8.0 2.00

Organ 2 4.00 3.3 4.5 2.40

Organ 3 23.00 34.0 33.0 22.32

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 Types of Quantitative studies
• Descriptive Studies
• Objective: To describe and summarize characteristics of a population or
phenomenon.
• Case Reports/Case Series:
• Purpose: To document and describe the clinical features of a single patient or a group of
patients with a similar condition.
• Example: Reporting on a series of patients with a rare side effect from a medication.
• Cross-Sectional Studies:
• Purpose: To assess the prevalence of an outcome or characteristic at a single point in
time.
• Example: A survey measuring the prevalence of diabetes in a specific population at a
given year.

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 Design of quantitative study
1. Descriptive study
i. Case studies- A case study is an in-depth, detailed examination of a particular
case (or cases) within a real-world context, can be both qualitative and
quantitative. For example, 1.case studies in medicine may focus on an individual
patient or ailment; case studies in business might cover a particular firm's strategy,
2. in politics operations of a specific political campaign
ii. Case series- that tracks subjects with a known exposure, such as patients who
have received a similar treatment

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 Example- Case study
• Case Study: Management of Type 2 Diabetes in a 55-Year-Old Patient
• Patient Profile
• Name: John Doe (pseudonym)
• Age: 55 years
• Gender: Male
• Medical History: Diagnosed with Type 2 Diabetes Mellitus (T2DM) 5 years ago. History of
hypertension and high cholesterol.
• Current Medications: Metformin, Lisinopril, Atorvastatin.
• Lifestyle: Sedentary lifestyle, overweight, smokes 1 pack of cigarettes per day, and consumes a high-
fat diet.
• Clinical Presentation
• John presented to his primary care physician with complaints of:
• Increased thirst and frequent urination over the past month.
• Fatigue and blurred vision.
• Difficulty controlling blood glucose levels despite adherence to current medication.

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 Case series
• Case Series: Efficacy of Remdesivir in Patients with Severe COVID-19
• Study Reference
• Title: “Remdesivir for the Treatment of COVID-19 — Final Report”
Authors: William D. Muldoon, M.D., et al.
Published in: New England Journal of Medicine
Date: October 8, 2020
• Background
• Remdesivir, an antiviral drug originally developed for Ebola, was repurposed and investigated for its efficacy in
treating COVID-19. This case series explored its effectiveness in patients with severe COVID-19, who were
hospitalized and required supplemental oxygen.
• Study Design
• Type: Case Series
• Duration: April 2020 to May 2020
• Setting: Multiple hospitals in the United States
• Sample Size: 53 patients
• Conclusion- This case series suggests that Remdesivir can effectively reduce the time to clinical improvement in
patients with severe COVID-19.

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 2. Analytical studies
Objective: To explore relationships between variables and determine associations or effects.
• Cohort Studies:
• Purpose: To examine the effects of a specific exposure or risk factor on the incidence of an outcome over
time.
• Design: Follow a group of individuals exposed to the risk factor and compare them to a non-exposed group.
• Example: A study tracking the long-term health outcomes of smokers versus non-smokers.
• Case-Control Studies:
• Purpose: To identify and compare exposures or risk factors between individuals with a specific outcome
(cases) and those without it (controls).
• Design: Start with individuals with the outcome and look backward to identify and compare exposures.
• Example: Investigating the association between dietary habits and the risk of developing cancer by
comparing patients with cancer to those without.

• Cross sectional:
• studies variables of interest in a sample of subjects are assayed once and the relationships between them
are determined. Snapshot of whole population at once.

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• Cross-sectional studies are used both descriptively and
analytically.
• Descriptive cross-sectional studies simply characterize the
prevalence of a health outcome in a specified population.
Prevalence can be assessed at either one point in time (point
prevalence) or over a defined period of time ( period
prevalence).

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i. Cohort study: prospective" in nature - some variables are
assayed at the start of a study (e.g., dietary habits), then after a
period of time the outcomes are determined (e.g., incidence of
heart disease). Exposure to a particular chemical, water from
a particular source, etc. seems to lead to a particular disease
state
ii. Case control or retrospective: studies compare
cases (subjects with a particular attribute, such as an injury or
ability) with controls (subjects without the attribute)

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iii Cross-Sectional Studies:
• Purpose: To measure the relationship between an exposure
and an outcome at a specific point in time.
• Design: Collect data on exposure and outcome simultaneously.
• Example: Assessing the relationship between physical activity
levels and the prevalence of obesity in a population at one
point in time.

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 Framingham Heart Study COHORT STUDY
• The study was formally established from 1948–1953 in the town of
Framingham MA, west of Boston. Approximately 10,000 individuals were
found to be of ages 30–59 years from a total population of 28,000.
• Objective- To identify common factors or characteristics that contribute to
cardiovascular disease.
• Outcome- Factors contributing CVS disease- High blood cholesterol,
physical inactivity, smoking, obesity and overweight, and uncontrolled
stress or anger.
• The Framingham Heart Study has been instrumental in advancing our
understanding of cardiovascular disease and risk factors. Its extensive data
collection and longitudinal design have provided critical insights that have
shaped modern cardiovascular medicine and public health strategies.

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 Uses of descriptive and Analytical studies
• Health care planning
Descriptive studies provide knowledge about which populations or
subgroups are most or least affected by disease. This enables public health
administrators to target particular segments of the population for
education or prevention programmes and can help allocate resources more
efficiently.
• Hypothesis generation
Descriptive studies identify descriptive characteristics which frequently
constitutes an important first step in the search for determinants or risk
factors that can be altered or eliminated to reduce or prevent disease.
• Trend Analysis
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 Draw backs
• Common misuses of descriptive studies involve a lack of a clear, specific and
reproducible case definition and establishing a casual relationship which the data
cannot support.
• Whilst descriptive studies can highlight associations between variables or between
exposure and outcome variables, they cannot establish causality.
• Descriptive studies do not have a comparison (control) group which means that
they do not allow for inferences to be drawn about associations,

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 3. Experimental study/ intervention trial

1. Without a control group

2. With a control group

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 Before-and-after without Control Design
In such a design a single test group or area is selected and the dependent variable is
measured before the introduction of the treatment. The treatment is then introduced
and the dependent variable is measured again after the treatment has been introduced.
The design can be represented thus:

Test area:
Level of phenomenon Treatment introduced Level of phenomenon
before treatment (X) after treatment(Y)

Treatment Effect = (Y)-(X)

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 After-only with Control Design

In this design two groups (test group and control group) are selected and
the treatment is introduced into the test group only. The dependent variable
is then measured in both the areas at the same time.. This can be exhibited
in the following form:
Treatment introduced

Level of phenomenon after

Test group:
the treatment (X)
Control group level of phenomenon without treatment (Y)

Treatment Effect = (X) – (Y)

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 Before-and-After with Control Design
In this design two groups are selected and the dependent
variable is measured in both the areas for an identical time-
period before the treatment. The treatment is then introduced
into the test area only, and the dependent variable is measured
in both for an identical time-period after the introduction of the
treatment.
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Contd…
This design can be shown in this way:
Time Period I Time Period II

Treatment
Test group: Level of phenomenon Level of phenomenon after
before Treatment (X) introduced Treatment (Y)

Control group: Level of phenomenon Level of phenomenon without

without Treatment (A) Treatment (Z)

Treatment Effect = (Y – X) – (Z – A)

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 Completely randomized design (C.R. design)
• Involves only two principles viz., the principle of replication
and the principle of randomization of experimental designs. It is
the simplest possible design and its procedure of analysis is also
easier. The essential characteristic of the design.

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 Completely randomized design
Randomly Randomly
Population Sample
selected assigned

Experimental Control
group group

Treatment A Treatment B

Two-group simple randomized experimental Independent variable

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design
 Completely randomized design
• Three characteristics define this design: (1) each
individual is randomly assigned to a single treatment
condition, (2) each individual has the same probability of
being assigned to any specific treatment condition, and
(3) each individual is independently assigned to treatment
conditions.

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 Randomized block design

• In the R.B. design, subjects are first divided into groups, known
as blocks, such that within each group the subjects are
relatively homogeneous in respect to some selected variable.
• The treatments are randomly allocated to the experimental
units inside each block. When all treatments appear at least
once in each block, we have a completely randomized block
design.

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 Cross over design

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 Multiple cross over study
• A multiple crossover design is a
2 groups: G1- P, G2-T1
type of clinical trial where
participants receive multiple
treatments in a sequence, with G1- T1, G2-P
periods of washout in between to
ensure that the effects of one G1- T2, G2-P
treatment do not carry over into
the next period. This design
allows for each participant to G1- P, G2-T2
serve as their own control, which
can increase the efficiency of the
study and reduce the variability of
the results.

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Advantages Disadvantages
• Control of itself • Difficult for chronic disorder
• Require fewer subjects • Order of administration of dose
• Carry over effect

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 The type of design we choose for our study has a major impact
on the sample size. Descriptive studies need hundreds of
subjects to give acceptable confidence intervals (or to ensure
statistical significance) for small effects.
Experiments generally need a lot less--often one-tenth as
many--because it's easier to see changes within subjects than
differences between groups of subjects

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 Some imp. terms

• Single blind test

• Double blind test
• Placebo effect

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• Samples: How many subjects should you study?
• Statistical study
Detect means getting a statistically significant effect, which
means that more than 95% of the time.
The p value for the effect has to be less than 0.05 i.e it has to
be significant.

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• Confidence interval: simply want enough subjects to give
acceptable precision for the effect
• Precision refers usually to a 95% confidence interval precision
for the effect
• Validity: Validity represents how well a variable measures what
it is supposed to. Validity is important in descriptive studies: if
the validity of the main variables is poor, we may need
thousands rather than hundreds of subjects.
• Reliability: how reproducible our measures are on a retest
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