Introduction to Research Methodology (MEDICAL)

1. Presented By
(M.Sc. PG Student)
Department Of Physiology
Dr. Balasaheb Vikhe Patil Rural Medical College, Loni

2. • Research is an integral part of any
academic and non-academic learning,
innovations and developmental activities.
• An inherit feature of human being to add
something new, to expand the knowledge
by his forethought, serendipity or scientific
and systematic acquisition of facts and
figures.

3. • Research inculcates inductive thinking and
promotes development of logical habits of
thinking and organization.
• The research should be directed towards major
public health problems.
• There is need to create awareness and impart
training to the undergraduates and postgraduate
medical students in research.

4. • Research is the systematic
collection, analysis and
interpretation of data to answer
a certain question or solve a
problem.

5. • A discovery is recognizing something that
already exists for the first time, that nobody has
found before.
• Whereas, An invention is creating something
totally new with one’s own idea and
development.

6. • An invention is creating something entirely new,
whereas innovation is enhancing an existing concept.
i.e. inventors create new products or services, and
innovators work to improve and refine those products
and services.
• For example, the invention of stethoscope by Rene
Laennec led to subsequent innovation in chest
diagnosis. Before the invention of the stethoscope,
chest diseases were the number one killer. This
invention allowed doctors to make quicker diagnosis,
an impact that exists to this day despite having higher
tech tools.

9. • A hypothesis is an assumption, an idea that is
proposed for the sake of argument so that it can be
tasted to see if it might be true.
• When a hypothesis is proved true, by passing all
critical tests and analysis, it becomes theory.
• So, the hypothesis is very different from theory, as
the hypothesis is unproven but the theory is a
proven and tested statement.

10. • Add to scientific knowledge.
• Improve the medical and health practice.
• Benefits the patient and the community.
• Study new phenomenon for establishing the facts.
• Help in planning the medical and health programs.
• Support managerial aspects of health development.
• Improve diagnostic techniques by newer, cheaper
and accurate tests.
• Help in effective patient care management.

11. • The statement of the problem or the purpose should be
clear.
• It should have a plan (procedure to be described in
detail).
• The research design should be in detail and clear.
• The researcher should be honest, transparent and
committed and should report frank observations
without distortion.
• The data should be collected as required and be
analyzed appropriately.
• It should be systematic, logical and empirical (based on
experiments or evidences, not on ideas).

12. • Lack of scientific training in research methodology.
• Lack of infrastructure.
• Insufficient interaction between the research
institutions and the other
organizations/institutions.
• Duplication of research studies.
• There is no code of conduct for researchers.
• Inadequate secretarial assistance.
• Mismanagement of library functioning and
publications.

13. • Research methods are broadly classified as
Qualitative and Quantitative.
• Both methods have distinctive properties and
data collection methods.

14. • Qualitative research is based on qualitative data.
Qualitative data can help us to understand why,
how, or what happened behind certain behaviors.
Case studies are the examples of qualitative studies.

15. • Quantitative research is based on quantitative
data. Quantitative data tell us how many, how
much, how often in calculations. The case
control study, cohort study, clinical trials etc.
are the examples of quantitative studies.

16. 1. Identify the problem
2. Formulating a research question
3. Refining the research question : literature review
4. Formulating hypothesis and research objective
5. Decide the study population and setting
6. Decide on study design and methodology
7. Writing the protocol
8. Collecting the data
9. Analyze the data and apply statistical significance
10.Write the report

17. • Interest and expertise: The topic should be
interesting to the investigator, funding agency
and the medical community.
• Relevance and applicability: Research should
add new information to the scientific society
or expected result is likely to alter clinical
decisions in future
• Feasibility: Should be feasible in terms of time,
man power and money.

18. • Research question is a formal statement of the goal
of the study.
• Foremost among these is whether the question is
interesting.
• It is important that the investigator is genuinely
curious about the question being investigated, so
that he or she can remain motivated till the
successful completion of the study.
• Curiosity is also an asset in terms of stimulating
questions for future studies.

19. • Next is feasibility
• The third consideration is the novelty factor, or
the potential of the study to contribute
something new to the knowledge base.
• Related to the novelty is the relevance of the
research question.
• It should add to existing knowledge, guide future
studies, or have implications on education,
clinical practice or health care policy.

20. • Finally, the idea must be ethical : Studies that
invade people’s privacy or create possible
physical or psychological risks are ethically
unacceptable.

21. • F: Feasible
• I: Interesting to the investigator
• N: Novel
• E: Ethical
• R: Relevant

22. • Once the problem or question is specified, the
next step is to collect as much related
information as possible.
Literature review will help to determine to what
extent the issue or research question has been
previously researched as well as method used.

23. • “Six hours in the library may save the
researchers six months in the laboratory”
• Whether an investigator is starting a short
project or a research degree, there will be a
need to carry out retrospective search for
discovering information.
• Discovering information on a new topic may
involve use of both printed and electronic
information published in formats such as journal
articles, reports, books and documents on the
internet.

24. • Always remember the books are approximately 2-3
years out of the date when published, whereas
review articles published in journals contain more
current material.
• Review articles are the best starting point, it is
written structured account of the subject with a
comprehensive reference list.

25. • The research hypothesis is developed from
the research question
For example, in the research studies
comparing treatment X versus treatment Y in
patient with pneumonia, the experimental
group would be treatment X and the
control/conventional group would be
treatment Y

26. The investigative team would first state a
research hypothesis.
This could expressed as a single outcome, e.g.,
treatment X leads to improve functional
outcome

27. • The definition of the subject of study and the
target population should be clearly spelt out
The inclusion and the exclusion criteria should
be decided in the beginning itself.
Sample size is very important. The smaller the
sample, the more will be the uncertainty.
Sample size should be chosen in such a way
that the finding in the study accurately reflects
what is going on in the population.

28. • Study design is the framework in which investigation is planned
and carried out.
• Selection of design is based on type of research question.
• Observational
Studies in which subjects are observed-includes:
I. Case study/ Case series
II. Case control
III. Cross sectional
IV. Cohort/ Longitudinal
• Experimental
Studies in which the effect of an intervention is observed
I. Controlled trails
II. Diagnostic test

29. • Case studies are simply reports of events
observed in single patient. Whereas, case
series are collections of patients, all whom
have single exposure, whose clinical outcomes
are then evaluated and described.

30. • These are used to compare two groups, such
as subjects with and without disease to look
for differences in risk factors.

31. • These studies observe a population at a
specific time point as opposed to observing
patients for a certain duration of time.

32. • These studies look at patient that share
specific criteria such as age or place or doctor

33. • All the efforts put into preceding steps culminates
into the draft of the research protocol that
incorporates all the information regarding the
research in a concise manner.
• The protocol should contain background
information on the study, objectives, ethical
aspects, study design, study procedures, method
of assessment, statistics and evaluation,
administrative issues and references.

34. • Once the protocol is ready, approval from the
Ethics committee should be obtained before the
start of the study.
• Along with the protocol, the informed consent
form and other documents required should also
be submitted to Ethics committee for approval

35. • Once the protocol is finalized, the data should be
collected
• The data forms should be legibly filled, and they
should be fully completed
• Ethical issues must be taken care of from the
beginning to the end of study
• In drug trails care must be taken to document the
details of adverse events if any
• Proper documentation throughout the study is
important to ensure credibility of data

36. • The data should be scrutinized for internal
consistency and external validity.
Data should be analyzed using the already
decided data management plan

37. • The report should be sufficiently detailed that
can remove any doubt a reader might have
about any aspect of results
• It should be properly worded, should be
adequately illustrated by charts or diagrams or
tables which enhance the clarity

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