Research Overview Fundamentals of Research Study Design

1. RESEARCH
Professor Syed Amin Tabish
FRCP (London), FRCP (Edin.), FAMS, MD (AIIMS)
Postdoc Fellowship, Bristol University (England)
Doctorate in Educational Leadership (USA)

3. Research
Research is an
ORGANIZED and
SYSTEMATIC way of
FINDING ANSWERS to
QUESTIONS

4. Research - II
SYSTEMATIC
 Because there is a definite set of
procedures and steps which you will
follow.
 There are certain things in the
research process which are always
done in order to get the most
accurate results.

5. Research - III
ORGANIZED
 in that there is a structure or
method in going about doing
research.
 It is a planned procedure, not
a spontaneous one. It is
focused and limited to a
specific scope.

6. Research - IV
FINDING ANSWERS
 is the end of all research.
 Whether it is the answer to a
hypothesis or even a simple
question, research is successful
when we find answers
 Sometimes the answer is no, but
it is still an answer.

7. Research - V
QUESTIONS
 Are central to research. If there
is no question, then the answer
is of no use
 Research is focused on relevant,
useful, and important questions
 Without a question, research
has no focus, drive, or purpose.

8. Research - VI
It is an attempt by careful enquiry,
experimentation, study,
observation, analysis and
recording to:
 discover new facts, knowledge
and information,
 develop new interpretations of
facts, knowledge or information,
or discover new means of
applying existing knowledge.

9. Types of Research
 Disciplinary research (focus on
Theory)
 Biomedical Research (focus on
Organisms)
 Clinical Research (focus on
Individuals)
 Health Services Research (focus on
Systems)
 Public Health Research (focus on
Community)

10. Basic (Primary) Research
 A theoretical or
experimental investigation
to advance scientific
knowledge where
immediate practical
application is not a direct
objective.

11. Secondary Research
An experimental
investigation to
advance scientific
knowledge where
immediate practical
application is a direct
objective

12. Applied Research
An experimental
investigation which
makes use of existing
knowledge for new
applications or to
significantly improve
existing applications

13. Quality Research
 Quality of any research study
depends on how well both
design and execution phases of
the project are accomplished.
 There is a positive relationship
between the research protocol
and overall quality and
acceptance of the resulting
research study

14. Components of a Research Protocol
 A descriptive title
 The name, titles, degrees,
addresses and affiliations of the
investigators and co-investigators
 Introduction & Background
 Literature review
 Justification/ Rationale
 Study objective and /or research
questions

15. The Components of Protocol-II
Study Methodology
Study population and its
recruitment
Study design
Study setting
Study duration

16. Components (contd.)
Sample size determination
Sampling strategy
Variable list
Methods of data collection
Data collection tools
Plan of Analysis

17. The components (contd.)
 Ethical considerations & humane
subject protection
 Quality control
 Expected benefits from the study
 Operational plan & budgeting
 Plan of dissemination of results
 References
 Biographical information on
investigator and institution

18. Study Title
 It should be brief and
explanatory.
 Better to include type of study
and setting.
 Like `A case-control study of
risk factors of acute hepatitis
B in Al-Qassim`.

19. Introduction & Background
Relevant details about
the problem.
The pathophysiology of
the disease, global
burden, similar settings
and then local (if
available)

20. Literature Review
 A description about what other
in this field in other countries
and in your country has done.
 Literature review should be in
depth to identify potential
cofounders and effect
modifiers and to determine the
areas in which knowledge is
needed.

21. Justification/Rationale
It should tell that why
you want to do this
study.
Is there any gap in the
existing knowledge that
you want to fill?

22. Study Objective/Research Question
 It should identify the
immediate purpose of study
and be very clear.
 Objective always start with
`to` (word of accomplishment)
 Like `To identify the risk
factors of acute Hepatitis B in
Qassim`

23. Research Question
 The Research Question is
expressed in ideas & concepts
 Research Design is the plan of
how the research will be carried
out
 Hypothesis: sets of ideas or
concepts
 Question comes as a flash of
inspiration; or may arise from
routine observed events

24. Exploring the Question
 Having identified a Question
 Investigate the Background of
question
 Has someone else had a go at
answering it
 Is the answer known
 Has someone formulated it in a
better way

25. Sample Questions
 Do Non-Steroidal anti-inflammatory
agents cause cancer
 Are patients who complain of
dizziness likely to suffer from a
serious disease
 Is Asthma more common in only
children
 Is there an association between H.
Pylori and Coronary artery disease

26. Methodology
It should include the detail
description of methods
with reasoning.

27. Design
What you want to do, how you are
going to recruit subject, & how
to follow :
 Randomized controlled clinical trial
 Cohort Study
 Case Control Study
 Cross-sectional Study
 Case series
 Case reports

28. Study population & its recruitment
 Description of study
population
 Inclusion and exclusion
criteria (Exclusion criteria
apply after those who are
included in study).

29. Study Setting
 Description of the setting whether
it is a community or a hospital
 In case of hospital what are the
important characteristic of
this/these hospital which type of
patient visit this; what is its
catchment area, how big it is and
what diagnostic and treatment
facilities it have. Is it a special
centre for some specific disease.

30. Study Duration
If you are mentioning
the field work duration
specify it

31. Sampling strategy
How sampling will be
done; whether is random
(type of random sampling)
or convenient sampling.
How cases and controls
will be identified.

32. Variables List
What variables you want
to measure.

33. Methods of Data Collection
 What method you are going to
apply as records, questionnaire
and in person interview, mailed
questionnaire etc
 What test you are applying and
what is reason for applying this
test.
 Specificity & sensitivity of the
test, if some new test is to be
applied.

34. Plan of analysis
 How you are going to analyze your
data. For what you are looking for
and which statistical method will
apply.
 Whether you run descriptive
analysis or go for hypothesis
testing and may be multivariate
analysis.
 It is better to get help from
biostatistician for sample size and
data analysis.

35. Other Considerations
 Expected benefits from the study
 Who will and how benefit from the study
 Operational plan & budgeting
 Detail time line and budget for the study
 Plan of dissemination of results
 How the findings will be shared
with others: presentations, publishing
results in journal etc.

36. Dissemination of Results
How the findings will be
shared with others
presentations,
publishing results in
journal etc.

37. SUMMARY
STEPS IN
RESEARCH
METHODOLOGY

38. STEP 1
 Statement of :
 What is bothering you or what are you
interested in
 An idea that needs to be verified
 A problem that needs to be solved
 A technique that needs improvement
 A hypothesis that needs to be proved
 A solution that needs to be bettered
 A gap in knowledge that needs to be
filled

39. STEP 2
 Review of literature
 What has been written or done on the
subject
 Helps you understand your concern /
questions better
 Tells you how other people have done
the study
 Also tells you what the results of other
studies were
 If review already answers your
question (s) then you may not need to
do the study on this subject

40. STEP 3
Defining the objectives
precisely and concisely
in the light of what has
been done or what is
known (literature
review)

41. STEP 4
How to achieve the
objectives
The methodology

42. STEP 5
 What is the hypothesis (statement
of belief)?
 Are you seeking a hypothesis by
trying to find a relationship
between many variables or are
you testing a hypothesis?
 Your study question or
hypothesis will determine the
methodology including the study
design

43. STEP 6
 Determine the importance of the
study
 Rationale of the study….why do
you want to do the study
How will your study benefit
New discovery?
Add to existing knowledge?
Improve services?

44. STEP 7
 Develop a detail methodology in
consultation with a statistician and
other disciplines you plan to use
 Where……site of study
 What……..study subjects
 When…….Sequence of work
 How
 Study design
 Data collection instrument
 Data collection methods
 Data analysis method
 Quality check of data collected

45. STEP 8
 Can valid conclusions be drawn by
the methods you plan to use?
 In other words, what is the validity of
the measuring instruments/methods?
 Is the number of subjects,
observations statistically adequate
and is the method of sampling used
correct
 Has all the possible effort been made
to remove / reduce bias in the
designing and sampling of the study?

46. STEP 9
Determine the feasibility of the study
Can the study be done
In the time available
In the resources available
Will it require help from other
disciplines (laboratory, radiology,
medical records dept etc)…..will this
help be available
Will you require help to gain
permission from other sources….will
permission be given etc etc

47. Thank you
very much