This document provides an overview of research methodology. It defines what research is and discusses different types of research including epidemiological, basic, applied, operational, and action research. It also covers study designs such as observational and experimental studies. Key aspects of developing a research question like formulation and using the PICO/PECO framework are explained. Study objectives, hypotheses, variables, and ethics are also addressed. The document concludes with suggestions for critically reviewing a research article by evaluating aspects like introduction, methods, analysis, results, and conclusions.

1. Research
Methodology
BY: DR SANTOSH KUMAR SOREN
JRA I , DEPT OF PSM

2. What is a research.
It is pursuit of a better understanding of the facts and phenomenon around us.
Research is an art of scientific investigation.
Essentials
¤ Keen observation of the universe
¤ Constant thinking
¤ Systematic approach

3. Learning objectives
 What is research and its types.
 Over view of different study designs.
 Formulation of a research question.
 Critically reviewing a research article.

4. Types of research
¨ Epidemiological
¨ Basic/ fundamental
¨ Applied
¨ Operational
¨ Action

5. Epidemiologic Research
Epidemiology is the study of how often health events and/or behaviours occur in different groups of people
and why.
Used to plan and evaluate strategies to promote health and to prevent/ manage illnesses.
Examples

¨ Level of infant mortality in the population

¨ Causes and determinants of infant deaths

¨ Role of surfactant in reducing deaths due to RDS

6. Basic research
This includes anatomical , biochemistry , physiological research.
Examples ; discovery of surfactants
; action of vaccines.

7. Applied research
Applied research deals with practical application of science.
Applied research resides in the messy real world.
Employs empirical methodologies; strict research
protocols may need to be relaxed.
Transparency in the methodology is crucial.

8. Operational research
This is basically related to the management of resources.
Examples: patient care.
: pharmacy
: biomedical waste management.
: community participation.

9. Action Research
¨ A reflective process of progressive problem solving led by
individuals working with others in teams.
¨ Carried out in the course of an activity
¨ Dual commitment.
To study a system and concurrently to collaborate with members
of the system in changing it in a desirable direction

10. The 10/90 gap
¨ Only 10 per cent of global health research is devoted to conditions that
account for 90.
¨ Developing countries bear 90% of the global disease burden

11. Study design
Epidemiological study
Observational Descriptive
Ecological
Cross sectional
Case control
Cohort
Experimental
RCT/NRCT

12. Did the investigator assigned
intervention
Experimental Study Random allocation
Observational
study
Comparison group
yes
no yes
Analytical
Cross
sectional
Cohort
Case control
no
Descriptive
RCT
NRCTs
no

13. Research Question

14. . • IDEA EMERGES
.
• BRAIN STORMING
.
• LITREATURE REVIEW AND IDENTIFICATION OF VARIABLES
RESEARCH
QUESTION

15. Research Question
Research question drives the study –
Exactly what are you planning to do?
Essential elements
• Is the rationale clear?
• Has the population been identified?
• Has it identified the variables to be studied?
Should be empirically measurable.

16. Research question framework
PICO/PECO
• P – Who are the Patients or what’s the Problem?
• I or E – What is the Intervention or Exposure?
• C – What is the Comparison or Control group?
• O – What is the Outcome or endpoint?
• PICO-TS ( Time, Settings)

17. Did the investigator assigned
intervention
Experimental Study Random allocation
Observational
study
Comparison group
yes
no yes
Analytical
Cross
sectional
Cohort
Case control
no
Descriptive
RCT
NRCTs
no

18. Did the investigator assigned
intervention
Experimental Study Random allocation
Observational
study
Comparison group
yes
no yes
Analytical
Cross
sectional
Cohort
Case control
no
Descriptive cross
sectional
RCT
NRCTs
no
PICO
PECO
PO

19. Research question – Primary
Does a 3-dose series of BRV-PV administered orally one month
apart and beginning at 6 weeks help to prevent severe rotavirus
gastroenteritis through adequate IgA in healthy Indian infants
when concurrently administered with standard UIP vaccines as
compared to a placebo?

20. Research question – Secondary
• Will the BRV-PV be safe and well tolerated?
• Will the BRV-PV induce IgA sero response in at least 50% of recipients?

21. Essential criteria vs PICOT
• Is the rationale clear?
• Has the population
been identified?
• Has it identified the
variables to be
studied?
• Is it possible to
empirically test it?
P : Indian infants
I :BRV-PV trial vaccine
C :Placebo
O : SRVGE
T :12 months
S :???

22. Study hypothesis
Primary hypothesis
• A 3 dose series of BRV-PV administered orally to healthy Indian
infants, with the initial dose given at 6-8 weeks of age and
followed by vaccinations at monthly intervals will significantly
reduce the incidence of severe rotavirus gastroenteritis (SRVGE).
Secondary hypothesis
• The BRV-PV will be safe and well tolerated.
• The BRV-PV will induce IgA sero response in at least 50%
of recipients.

23. Study Objectives

24. Primary Objective
To evaluate the efficacy of a 3-dose series of BRV-PV administered orally to prevent
severe rotavirus gastroenteritis in healthy Indian infants when concurrently
administered with standard UIP vaccines

25. Secondary Objective
 1. To evaluate vaccine safety (reactogenicity, adverse events
[AEs], serious adverse events [SAEs], intussusception, death).

2. To evaluate vaccine efficacy against SRVGE caused by G
serotypes included in the vaccine (G1, G2, G3, G4 and G9) .

3. To evaluate the immunogenicity of BRV PV in a subset of
participants.

4. To evaluate vaccine efficacy to reduce hospitalizations due to
rotavirus gastroenteritis

26. Critiquing a Research Article

27. INTRODUCTION
• Is the research question researchable?
• Is the problem important enough to justify the research?
• Is the background of the research relevant to the research
question?

28. AIMS AND OBJECTIVES
• Do you have a clear idea of what the study tried to achieve?

29. STUDY DESIGN
• Is the research method appropriate for the research question?
• Was the collection of data appropriate for the research question?
• Is there enough information concerning the participants?
• What were the ethical considerations for the research and the
participants?

30. STUDY DESIGN
• Were the methods / instruments described in enough detail?
• Were any ambiguous terms used?
• Are any limitations of the study discussed?

31. ANALYSIS & RESULTS
• Were the steps involved in the data analysis explained and the
strategies justified?
• Was the data analysis rigorous enough to substantiate the claims?
• Were all data taken into account? If not, why not?
• Are the presented results relevant to the research question?
• Do the tables and graphs make the data analysis clearer?

32. DISCUSSION
• Have the results been discussed with reference to the research
question or hypothesis?
• Have conclusions been appropriately drawn from the data analysis?
• Did the researcher highlight the most important results?
• Have the results been used to support or refute the results of other studies?
• How relevant and useful are the results to practice?

33. CONCLUSION
• Were the main points drawn out?
• Were fresh insights or a new perspective on the topic demonstrated?
• Have any recommendations been made based on the research?
• Were there any suggestions for future research?

34. REPORTING GUIDELINES
Study Type Guideline
Randomised trials ; CONSORT
Observational studies ;STROBE
Systematic reviews ;PRISMA
Qualitative research ;SRQR
Diagnostic / prognostic studies ; STARD

35. REFRENCES
 Leon Gordis’s Text book of Epidemiology 5th edition
 Basic epidemiology workshop at MGIMS Wardha study materials.

36. Thank You