ASSOCIATE PROFESSOR

1. RESEARCH METHODOLOGY
DR. NIRAJ KUMAR
ASSOCIATE PROFESSOR PHYSIOTHERAPY DEPT.
SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND
HEALTH SCIENCES

2. •Clinical research is a structured process of investigating facts
and theories.
•It is a method of answering the questions in a systematic and
objective way to examine clinical conditions and outcomes.

3. Experimental research(Gold standard research)
• Pretest-posttest designs
• Post test only designs
• Complex variations (several independent
variable)

4. Experimental research
• Quasi experimental designs
• Sequential clinical trials
• Single case experimental designs

5. Non-Experimental research
Descriptive
or
Exploratory

6. Descriptive research
• Systematically describe and interpret conditions or
relationships that already exist.
• Involves questionnaires, , interviews or direct observation
Correlational research
• Used to examine the extent to which variation in
one variable corresponds with variation in one or
more other factors.

7. Epidemiology
• Concerned with the risk of disease or disability
associated with specific exposures.
– Surveys
– Experimental studies
– Correlational studies

8. Evaluation research
• An objective and empirical assessment of the
success of a program or policy in meeting its
goal and objectives.
• Used to assist
– Decision making
– Determining if a clinical program should be
implemented, continued, or modified

9. Methodological research
• Involves the development and validation of
measurement tools used in practice and
clinical research.

10. Purpose of a research design
Provide information regarding:
• What is the study?
• Why is the study being carried out?
• Where will the study be carried out?
• How will the study be carried out?
• What will be the processes and tasks involved?
• What will be the data?
• How will the data be collected?
• What methods of sampling will be used? and
• How will the analysis be done?

11. Functions of the research design
• Provide a plan to undertake systematic study
and help to provide procedures to undertake
the research work; and
• Ensure objective, valid, and economic
undertaking of the study.

12. Types of research design
Factors
• Nature of investigation,
• Data collection methods,
• Number of contacts made with the subjects,
• and the Period of reference

13. Nature of Investigation
• Exploratory
• Descriptive
• Experimental
• Semi or Quasi- experimental
• Non- experimental and
• Field research.

14. Data Collection Methods
• Survey
• Case studies and
• Content analysis

15. Definitions of Study Design
• Case–control study
– Retrospective comparison of exposures of persons with disease (cases) with those of persons
without the disease (controls). (Harm/Etiology) (EBM Toolkit, 2008)
• Case–series
– Report of a number of cases of disease. (Harm/Etiology) (EBM Toolkit, 2008)
• Cohort study
– A study that begins with the gathering of two matched groups (the cohorts), one which has
been exposed to a prognostic factor, risk factor, or intervention and one which has not. The
groups are then followed forward in time (prospective) to measure the development of
different outcomes. In a retrospective cohort study, cohorts are identified at a point of time in
the past and information is collected on their subsequent outcomes. (Diagnosis, Harm/Etiology,
Prognosis, Therapy) (EBM Toolkit, 2008)
• Meta–analysis
– Broad term that includes reports that collect and synthesize data from individual studies to
provide new information. (McKibbon, 2009)
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16. The research plan

17. Title
• Concise and informative
• Has an independent variable, dependent
variable and the sample.

18. Abstract
• Should be in one page
• It includes
– A brief description of the method
– Procedures
– Methods for data analysis
– The proposed duration of the study and overall
projected costs may be stated

19. Statement of the research problem
– Rationale and justification for the study
• Why the study was needed?
– Significance of the study
• What is the use?

20. Statement of the purpose of the
study
• Specific aims or objectives
– Help the researcher guide the discussion of results
when the study is completed (comparative,
correlational, reliability of an instrument and the
relationships)
• Research hypotheses or guiding questions
– Positive or negative

21. Aim
• to map, to develop, to design, to track, to
generate, to theorize, to build …
• Sometimes ‘to investigate, to understand, and
to explore…
• to synthesize, to catalogue, to challenge, to
critically interrogate …

22. Objectives
• There are usually more than one, are the
specific steps you will take to achieve your
aim.

23. Objectives
• Objectives are often expressed through active
sentences. So, objectives often start something like In
order to achieve this aim, I will… collect, construct,
produce, test, trial, measure, document, pilot,
deconstruct, analyse…
• The list of objectives spells out what you actually and
really will do to get to the point of it all.
• Objectives have to be practical, do-able and
achievable.

24. Background of the study
• Topics for review of literature related to
– Theory and supportive rational
– Related studies
– Methods
• Previous work by the investigator that supports
the project

25. Method
• Subjects : Characteristics, sampling method, plans for recruitment
• Materials: instrumentation, plans to establish reliability and validity
• Procedures
– Study design
– Details of test and treatment administration
– Data collection methods
– Timetable and organizational chart
• Data management and analysis

26. Literature cited
References should be in any one of the format
Vancouver
Harvard

27. Sampling

28. Population
• The larger group to which research results are
generalized is called a population.
– Defined aggregate of Objects
– Persons
– Places
– Organizations, animals, days etc.

29. Sample
• Through a process of
sampling, a researcher
chooses a subgroup of the
population, called a sample.
• It serves as the reference
group for drawing conclusions
about the population.

30. Target population
• Target or reference population: to study the
overall group of people
– OA
– Learning disability
– Gait dysfunction in hemiplegia

31. Target Population
Accessible population
Subject selection
Participants
Group assignment
Experimental Control
Nonparticipants

32. Sampling techniques
Probability method
•Random selection – equal chance
Nonprobability method
•Probability of selection is not known

33. Simple random sampling
• In clinical studies
– List the available population
– Chit method (equal size and shape)
– Tables of random numbers

34. Systematic sampling
• Lists arranged alphabetically or in some other
ordered fashion.
– 100 / 1000

35. Convenience
• Other name: accidental sample
• Most common form
• Chosen according to the availability of the
patient.
• Disadvantage: bias of self selection

36. Normality test
Less than 50 (<50)
• Shapiro – Wilk test
• If the significance value is
greater than 0.05
More than 50 (>50)
• Kolmogorov – Smirnov test
• KS Test
• If the significance value is
greater than 0.05

37. Parametric (Normal distribution)
• Parametric – paired t test (pre-
post design),
• Repeated measures Anova –
(Pre-Post-Follow up)
• Independent t test – individual
comparison of 2 data
(between group)
• One way Anova – to
comparison of all 3 group
• Pearson correlation – validity.
Nonparametric (Non normal distribution)
• Non- parametric - Wilcoxon (pre-
post design)
• Friedman test (Pre-Post-Follow up)
• Mann Whitney – individual
comparison of 2 data (between
group)
• Krusskal Wallis - to comparison of
all 3 group
• Spearman rank correlation
coefficient

38. Presentation of the research

39. Visual presentation
• Avoid confusing slides
• 4 types of slides may be presented
– Words or phrases (text)
– Photographs
– Graphs
– Tables

40. Words and Phrases
• Title
• Purpose
• Important background material
• Hypothesis
• Description of subjects and study protocol
• Summary of results and
• Conclusion

41. Abstract should contain
• Overview and purpose of the study
• General description of methods
• Highlights of results
• Statement of significance of results
• General conclusion

42. Abstract
• Abstract summarizes
– The purpose of the study
– Number and type of subjects
– The basic procedures used
– Summary of the results
– And the major conclusion
• Must be concise
• Word limits 100

43. Introduction
• Statement of the problem
• Clinical relevance
• Review of literature
• Rationale and theoretical framework
• Specific purpose and hypotheses (or guiding
questions)

44. Introduction should contain
• The 1st one or two paragraphs of the
introduction should have a clear
understanding of the problem being studied.
• The introduction should end with a statement
of the specific purpose of the study

45. Methodology should contain
• No. of subjects
• Selection criteria
• Informed consent
• Approved by the appropriate committees.
• Description of equipment
• Data collection procedures

46. Results should contain
• Should contain only a report of results
• Significant test and its probability.
• Tables and figures
• Statements to support or reject hypotheses

47. Discussion should contain
• Reflects the researcher‘s interpretation of the
results in terms of the purpose of the study and
the outside world.
• The should comment on
– Importance of the result
– Limitation of the study
– Suggestion for future research
– And clinical implications

48. Conclusion
• A brief restatement of the purpose of the study and its
principal findings.
• Author states the deductions made from the results.
• Phrases like “the results of this study indicates” and
“this study demonstrates” serve to link the summary of
results and the meaning of those results.

49. • List of all references cited in the article