This document provides an overview of research methodology. It discusses what research is, the need and purpose of research, and bottlenecks in health research. It defines different types of health research including public health, laboratory, and clinical research. Fundamental principles in health research are discussed. Key terms are defined, including research protocol, thesis, project, and survey. The differences between research methods and research methodology are explained. The life cycle of research and outline of a research protocol are presented. Guidelines for various sections of a research protocol such as the title, introduction, objectives, and methods are provided. Study designs including descriptive studies, case control studies, and experimental studies are described. Key concepts in study methodology like sampling, randomization, and

1. RESEARCH
METHODOLOGY
Moderator – Dr.
Anjan Das
Speaker – Dr. Sneha
Das

2. WHAT IS RESEARCH ?
• Research is a quest for knowledge through diligent search or
investigation or experimentation aimed at the discovery and
interpretation of new knowledge (WHO).
• Redman and Mory defined research as a “ systematized effort to gain
new knowledge .”

3. Need and Purpose of Research
• Backbone of evidence based medicine.
• Diagnosing and treating diseases.
• Provides evidence for policies and decisions on health and
development.
• Important for academic placements and promotions.

4. Bottlenecks
• Health research is not a priority in the education curriculum in India.
• Lack of qualified professionals to train others.
• Limited opportunities to learn.

5. Health Research
• It deals with generation of new knowledge using scientific method to
identify and deal with health problems .
TYPES OF HEALTH RESEARCH
PUBLIC HEALTH RESEARCH LABORATORY RESEARCH CLINICAL RESEARCH
Research which aims to study the
determinants of population
health ,generate knowledge to
improve public health practice ,
propose interventions and
policies , based on scientific
evidence .
Research carried out in a
laboratory for testing chemical
substances or disease causing
agents such as virus , bacteria or
developing new drugs and
performing microbiological,
biochemical , hematological tests
etc.
Research in which people , or
data or samples of tissue from
people are studied to understand
health and disease and find new
and better ways to detect,
diagnose, treat , and prevent
disease.
Eg – Health policy and systems
research , epidemiological
research
Eg- Basic research, animal
research, stem cell research ,
genomic research ,
pharmacogenetics
Eg- Clinical trials , record based
studies

6. Fundamental Principles in Health Research
• Planning stage is very critical – spend enough time and involve the
right people in planning .
• Team work is critical.
• Three levels of review are essential
Scientific review: Novelty, rationality, justification
Ethics review: Human subjects protection
Regulatory review: Foreign funding, sample shipment, intellectual
property, exchange of visitors.

7. Some Definitions
 Research Protocol – It is a document that outlines background and
rationale , objectives , study design, timeline, detailed methodology,
and statistical considerations necessary to conduct a research in a
scientifically sound systematic manner .
The principal objective of research protocol is to justify the
reasons for doing research and to lay down the proposed procedures
for conducting the research.
 Thesis – It is along essay or dissertation involving personal research ,
written by a candidate for a university degree .
 Project –It is an individual or collaborative enterprise that is carefully
designed and planned to find out new things in a time bound manner
with available resources .
 Survey- It is the investigation about the characteristics of a given
population by collecting data from a sample of the population .

8. Research Method Versus Research Methodology
RESEARCH METHODS RESEARCH METHODOLOGY
Research methods refer to all those methods /
techniques that are used for conduction of research
such behaviours and instruments used in making
observations , recording data, techniques of
processing data etc.
Research methodology is a way to
systematically solve the research problem. It
may be understood as a science of studying
how research is done scientifically .

9. Life Cycle of Research

10. Outline of Research Protocol
1. Title
2. Introduction
3. Review of literature
4. Objectives
5. Materials and methods
6. Outcome variables
7. Statistical analysis
8. Budgeting
9. Time line
10. Ethical consideration
11. References
12. Annexures

11. Word Limits in Research Protocol
• Title : 120 characters ( with spacing )
• Introduction : 300-500
• Review of literature : 800-1000
• Aims and objectives : Upto 200
• Materials and methods : 1200-1600
• References : 10-25 references

12. Two mandatory steps before writing the protocol :
1. Planning and defining the research problem
• At first, researcher must find out the problem or areas he/shewants to study or
explore.
• At the same time ,one has to look for practical feasibility i.e whether the study
can be carried out with available resources in the existing settings or not.
• Regarding identification of research problem ,one has to go through available
literature for the selected topic or discuss the same with senior faculty members
or colleagues.
2. Development of research question / working hypothesis

13. WHAT IS RESARCH QUESTION ?
• “Uncertainty” about something in the population that the
investigator wants to resolve by making measurements in the study
population .
• It is best to frame the research question using the PICO format
P- Population/patient/person with(or at risk of) a health problem on
which research is based.
I- Interventions
C-Comparisons
O-Outcome
Often (T) – Time frame is also added to the PICO format

14. Good Research Question Should Raise “so
what”Test?
• Feasible- Adequate number of participants , technical expertise and
resources .
• Interesting
• Novel – Provides new information
• Ethical- Amenable to a study that ethics committee will approve
• Relevant - To the scientific world of knowledge / clinical practice/
health policy.

15. Sources of Research Question
1. Mastering the published literature-
• Continue review of work of others in the area of interest.
2. Being alert to new ideas and techniques
• Attending research meetings /conferences
• Applying new technologies to old issues
3. Keeping the imagination roaming
• Careful observation, teaching
4. Choosing a guide or mentor

16. Steps in conceiving a Research Question

17. Research Hypothesis
• Includes
Sample
Study design
Dependent variable
Outcome variable
• Hypothesis is not required in descriptive studies. It is required for
studies which require or will use statistical significance to compare
findings among group.

18. Title
• The title must be brief , specific , and informative.
• It should reflect the research question.
• A balanced title should be either in PICOS (patient,intervention,
comparator, outcome, study design ) or SPICED format (Setting,
population, intervention, condition, end point and study design).

19. Introduction
1. Statement of problem : Define the problem systematically .
2. Reflect its importance : Relevance of the problem to national or
local health activities (rationale).
3. Statement of research hypothesis
4. Statement about how the results will be used i.e how the study will
be useful for policy makers, health administrators or health
scientists .
5. How the results will be transmitted to the appropriate audience.

20. Why perform literature review ?

21. Essentials for literature search
Sources of literature Method of search Skills of researcher
Published or formal literature
Eg- books, articles
Electronic/database search
Eg – PubMed , Google Scholar
,Scopus , EMBASE etc.
Information seeking skills (ability to
conduct electronic search)
Grey literature
Eg- conference proceedings ,
abstracts, government publications
Manual search
Eg- library, reference lists
Critical appraisal skills (describe ,
critique and relate each source to
the topic )
Unpublished literature Contacting researcher Organizational skills (logical analysis
and organization of the riview)

22. Steps of literature review
Step 1 : Frame research question
Step 2 : Search relevant literature
Step 3 : Assess quality of the
selected studies –
COREQ(Consolidated for
Reporting Qualitative Research)
and Quality Assessment Tool for
Quantitative Studies .
Step 4 : Analyze and critically
evaluate literature
Step 5 : Write the literature
review

23. Principles of PubMed Search
1. Word search
2. Field search
3. Using Boolean operators
4. MeSH terms ( Medical Subject Headings ) is the controlled
vocabulary of terms given by indexers in the National Library of
Medicine ,USA .

25. Objectives
1. Must meet the purpose of the study
2. Should be formulated clearly
3. Should be SMART
S: specific
M: measurable
A: attainable
R: reliable
T: time bound
4. Primary objectives
5. Secondary objectives

26. Material and methods
1. Study setting – where study is
conducted
2. Study design- descriptive ,
analytical, experimental
3. Study population-
reference/target population
4. Inclusion criteria
5. Exclusion criteria
6. Sample size
7. Sampling method
8. Study reference period
9. Study instruments such as
questionnaire, BP instrument ,
weighing machine

27. Outcome variables
• Independent variables
Synonyms – cause, input, predisposing factor, characteristics ,attribute
,determinant
• Dependent variables
Synonyms – effect , outcome ,consequence ,result , condition , disease
Eg- Will alcohol intake(independent variable)have an effect on
development of gastric ulcer (dependent variable)
• Confounding variables – these variables influence the effect of the
independent variables on the dependent variables .
• Background variables – gender, age, ethnic group, education, marital
status, social status

28. Statistical analysis
• Statistical software to be used for data analysis along with its version
has to be written . Eg – SPSS software , Epi-info software 3.2
• For descriptive analysis – mean, standard deviation, range
• For association – t test, chi square test, regression analysis, univariate,
bivariate, multivariate analysis

29. Budgeting
• Three types of costs
 Overhead
 Intermediate
 Recurrent
• Prepared on excel sheet (using formulas)

30. Timeline
• Protocol Submission
• Ethics Committee
• Data Collection
• Data Entry
• Data Analysis
• Presentation of results
• Writing

32. Ethical Consideration
• Informed Consent
• Participant information sheet

33. References
• Should be written in chronological order (from introduction onward).
• References are written in the Vancouver style.
• Authors(use et al. after 6 authors , if there are more than 6 authors,
complete names should not be written. “et al” must be in italics.
• Article title ( should be exact as existing).
• Journal name(should be in standard PubMed abbreviations, full journal
name should not be written)
• Year
• Volume
• Page numbers
• References should be numbered using Arabic numerals in box parentheses
e.g. [1] in the order of appearance in the text as a superscript .

35. Annexure
• Participant Information Sheet (in English, Hindi, Bengali)
• Informed Consent Form (in English, Hindi, Bengali)
• Questionnaire/ Interview schedule
• Permission letters

36. Study Designs

37. STUDY DESIGNS

38. Types of Descriptive Studies
CASE REPORTS
• Detailed presentation of a single case
• New or unfamiliar diseases
• Rare manifestations
• Generate hypothesis regarding pathophysiological mechanism
CASE SERIES
• Study of larger group of patients (e.g > 10) with a particular disease
•Larger number may allow the investigator to assess the play of chance
•Common way of delineating the clinical pictures of a disease
• Suffers from the absence of a comparison group
ECOLOGICAL STUDIES
• Group as the unit of analysis and to generate hypothesis
CROSS SECTIONAL SURVEYS
• Observation of a cross-section of a population at a single point in time
•Unit of observation and analysis: The individual
• Collect information about disease burden (also known as “prevalence studies” )

42. Case Control Study

46. Experimental Study Designs

48. Randomization
1. Randomization ensures that participants have an equal chance to
be assigned to one of two or more group.
2. Randomization provides the best way to prove effectiveness of a
new agent or intervention by ensuring all the groups are as similar
as possible and confounding ,bias are minimized .

49. Blinding
• Blinding can be at the level of-
Participants ( single blinding)
Participants and investigators (double blinding)
Participants, investigators and analysis ( triple blinding)

52. Study Population

53. Inclusion and Exclusion Criteria
• Inclusion Criteria are characteristics of the subjects that are
considered for inclusion in the study.
• Exclusion criteria are those conditions ,whose presence will
exclude the subjects from entering in the study.

54. Sample size calculation
For qualitative studies
• Calculate proportion
• Calculate the difference of proportion
For quantitative studies
• Calculate the mean
• Calculate the difference in mean
MC formula for cross sectional studies = 4PQ/d2
P – prevalence
Q – 100-P
d- allowable error

55. Sampling Methods
• Definition of sampling- Procedure by which some members of the
population are selected as representatives of the entire population.
• Types of sampling –
1. Probability sampling / Random sampling- equal and known chance
2. Non probability sampling/Non random sampling – no equal chance,
selection bias.
Random Sampling Non Random Sampling
Simple Random Sampling Convenience
Systematic Random Sampling Quota
Stratified Sampling Snow Ball
Cluster Sampling
Multistage sampling

58. Study tools and technique
• Study tools- The different instruments that are required to conduct
the study are known as study tools or study instruments.
• Study technique- The manner in which data collection is done is
known as study technique. These may be
Interview of the respondents
Observation
Clinical Examination
Measurement of blood pressure, weight, height etc.
Laboratory examination- blood test, sputum test etc
Scrutiny of the record registers like admission/discharge registers
Review of the past clinical and pathological records

59. Outline of Final Thesis/Report Writing/Article
1. Title
2. Introduction
3. Review of literature
4. Objectives
5. Materials and methods
6. Budgeting/Financial Grants
7. Ethical Consideration
8. Results
9. Discussion
10. Strengths
11. Limitations
12. Conclusions
13. References
14. Annexure
15. Conflicts of interest

60. Data Presentation
Quantitative Data/
Continuous Data
Qualitative Data/
Discrete Data
Miscellaneous
Histogram Bar Diagram Venn Diagram
Frequency Polygon Pie Tree Diagram
Frequency Curve Stem and Leaf plot
Line Chart Pictogram / Picture

61. Results / Analysis
• Here data are presented in texts , tables , diagrams depending upon
the situations . Only findings are to be stated , without any
interpretation/discussion.
• Result section should be arranged in a logical order under different
subheadings according to the objectives and different variables.
• Univariate, bivariate, multivariate analysis can be performed
according to the situation
• Avoid post hoc analysis and data dredging.
• Suitable statistical tests are to be performed and interpreted
accordingly.
• Avoid spreadsheets for data analysis. Use software such EpiInfo .

62. Discussion
• Major findings have to be interpreted with meaning and significance,
provide alternate explanations wherever applicable .
• Provide explanation whether the findings prove/disprove the
research hypothesis.
• Compare own findings with those of published studies.
• Similarities and differences of the present findings in the context of
existing relevant research work with possible explanations are to be
written in this section

63. Conclusions
It is a gist of the research work , which should state :
• Important findings
• Significance of the research work
• Prospect and practical applications of the findings
• Relevant recommendations based on the interpretation and
conclusions drawn from the study.
• Unanswered questions and future scope of further research related
to the topic.

64. Publication Ethics
Components of Publication Ethics-
1. Ethics Review/Breach of confidentiality
2. Fabrication and falsification
3. Authorship
4. Plagiarism
5. Ethics related to submission
6. Conflict of interest

65. Ethics Review/Breach of confidentiality
• Human/animal ethics committee approval as per National guidelines
• Informed Consent- A must when you are conducting research with
human participants.
• Data Confidentiality- Without institutional permission, you can not
share your data with someone for analysis who is working in a
different institution.

66. Fabrication /Falsification
• It is the research results which is not generated from the study
(fabrication) or generated by manipulating data (falsification) .
• Extremely serious misconduct .

67. Plagiarism
• Use of previously published manuscript by someone for his/her
manuscript or unreferenced use of other’s published and unpublished
ideas without consent ,credit or acknowledgement .
• Considered as serious publication misconduct
• Types-
Direct plagiarism- Complete or partial copying without
acknowledging the original author.
Self plagiarism- Duplicates of previous works or sentences.
Redundant publications- Publishing similar manuscripts /reports
based on same experiments.

68. How to avoid Plagiarism ?
• Avoid “copy paste”
• Write the concept in own words – spend more time
• Acknowledge original sources
• Cite references accurately
• Avoid writing several articles of the same type.
• Use of anti plagiarism software tools like ‘Turnitin’ .

69. Conflict of interest
• Financial , personal , social or other interests that directly or indirectly
influence the conduct of the author with respect to the manuscript.
• Disclose any such conflicts during submission ( mandatory ).
• Eg- A PG /researcher is conducting a drug trial which is funded by the
pharmaceutical company.

70. THANK YOU