How to Conduct Medical Research

How to conduct a research
Dr. Padmal de Silva MBBS. MSc (Community Medicine), MD (Community Medicine)
Consultant Community Physician
Department of Research and Evaluation
WHO Collaborating Centre for Public Health Workforce Development
National Institute of Health Sciences
Nagoda, Kalutara, Sri Lanka

What is Research ?
Department of Research– NIHS : Inspiring Public Health through Innovative Research

What research is
Step by step approach in conducting a
‘research’
Learning objectives?

• Research is the search for or creation of (valid)
knowledge.
• Knowledge is what is believed to be true about
something, what is believed to be a correct
understanding of something.
• Facts are just data. Knowledge is an expert’s best
interpretation of facts.
What is research?

• Research is defines as “the systematic approach to
obtaining new and reliable knowledge”.
• Notes that critical thinking is an essential element for
research.
Ethridge (1995)
What is research?

• It is the systematic investigation into and study of
materials, sources, etc, in order to establish facts and
reach new conclusions.
• It is an endeavour to discover new or collate old facts
etc by the scientific study of a subject or by a course
of critical investigation.
[Oxford Concise Dictionary]
What is research?

What is research?
Research is the
Systematic
Collection,
Analysis and
Interpretation of data
To answer a certain question or
Solve a problem
Department of Research – NIHS : Inspiring Public Health through Innovative Research

What is Health ?
Health
Is a state of “complete physical,
mental and social wellbeing
and not merely the absence of
disease or infirmity”
Preamble to the Constitution of the World Health Organization as adopted by the
International Health Conference, New York, 19-22 June, 1946; signed on 22 July 1946 by
the representatives of 61 States (Official Records of the World Health Organization, no. 2,
p. 100) and entered into force on 7 April 1948.
Department of Research – NIHS : Inspiring Public Health through Innovative Research

Determinants of Health
Agriculture
and food
production
Education
Work
environment
Living and working
conditions
Unemployment
Water and
sanitation
Health
care
services
Housing
Age, sex and
hereditary
factors
Health
Human Health is a complex and a dynamic issue

What is a health system?
• The institutional arrangements
within which the behavior occurs
• A set of cultural beliefs about health
and illness that forms the basis for health
seeking behavior
• The socio economic / political /
physical context for those beliefs and
institutions.
(the social determinants of health)

Institutional arrangements within which the
behavior occurs ……
1.The individual, family and community
2.Health care services
I. Public sector
a) Health workers
b) Health centers
c) Field care
II. Private sector
a) Traditional medicine
b) Private practitioners
c) Pharmaceuticals
d) NGO

Institutional arrangements within which the
behavior occurs ……
3. Health related sectors
I. Agriculture and food distribution
II. Education
III. Water and sanitation
IV. Transport and communication
4. The international sector
I. Bilateral and multilateral agencies

Cultural beliefs about health and
illness?
• What people believe (god, past deeds, planetary
alignment, hot and cold, etc…)
• Actual cause of illness ?
• Pathway to cure/ wellbeing?

Why do we need to conduct
research?
To see what is normal
To identify the abnormal
To find out what and which are associated
with the abnormal
To determine “causality”
To test new interventions
And finally “explore strange new
phenomena, seek out the truth, & to
boldly go where no one has gone
before”

Evidence Based Medicine (EBM)
What is E.B.M?
Are we practicing EBM?
Is practice / treatment based on evidence ?
This evidence they are referring to is from
research or studies …

Evidence Based Medicine (EBM)
In Sri Lanka
Are we conducting adequate research in Sri
Lanka?
Do we have a culture of conducting research?
To both these questions the answer is
“NO”

Some food for thought
Is evidence from other countries relevant to Sri
Lanka?
Do we blindly follow them?
Is it ethical to submit our people to Evidence
generated from Europe and USA?

Some more food for thought.
Do we share the same potential as Americans
and Europeans to use their growth standards?
When we say “our children are stunted or wasted”
are they really so?
Is western medical treatment really better than
“Ayurvedic treatment”
What sort of behavioral modifications do we need
for the NCD problems? Are western modifications
really applicable to us?

Why don’t we conduct enough “Research”?
• Don’t know how to conduct Research
• Don’t have the time
• Don’t have adequate facilities
• Don’t see a need to conduct research
• Conduct research but don’t publish it
• Research evidence not taken up for action
• No culture for “research”
THERE IS LACK OF RESEARCH

Components of a research
• Statement of the problem
• Literature review
• Aims
• Design of study
• Study setting
• Study population
• Study sample and sample size calculation
• Sampling Methods
• Data collection methods and study instruments
• Data collectors
• Analysis of data and presentation of results
• Ethical issues
• Discussion
• Conclusions

A researcher needs to develop capabilities in
• Conducting a literature review - Pub med / HINARI
• Referencing and bibliography - Endnote / Mendally / cite fast
• Calculating of sample size - Open epi or Win pepi
• Developing instruments
• Adhering to ethics and getting ERC approval
• Preparation of a research proposal
• Data base development using Epidata
• Data quality assessment
• Performing simple analysis SpSS OR Epi Info
• Writing a research report
– Abstracts
– Policy briefs
– Short report

CONDUCTING RESEARCH

• It demands a clear statement of the problem.
• It requires clear objectives and a plan (it is not
aimlessly looking for something in the hopes that you
will come across a solution).
• It builds on existing data, using both positive and
negative findings.
• New data should be systematically collected and
analyzed to answer the original research objectives.
Characteristics of a research

• First priority is to formulate your research question
• Then figure out how you are going to answer it
– How have others answered it?
– How does your proposal fit in with what others
have done?
– How will you know when you have answered it?
• Then you can present your answer
From where do I begin?

Steps of Scientific
Research
Selection of area
Selection of topic
Crude research question
no answer
Refined research question
Research hypothesis, goals and objectives
Study design
Population & sampling
Variables confounding bias
Research tools
Pilot study
Work plan
Collection of data
Data management
Interpretation
Reporting
no need for study
answers found
Literature review
Ethical issues

Is based on criteria such as:
1. Relevance
2. Avoidance of duplication
3. Urgency of data need
4. Political acceptability of the study
5. Feasibility of the study
6. Applicability of results
7. Ethical considerations
Criteria for selecting a research
topic

A useful link @ http://www.wikimindmap.org/

It need not be so………….

Why do it?
• Identify/focus topic
• Enhance knowledge about the problem
• Identify study variables
• Formulate hypothesis
• Interpret results
• Identify research method
– Including data analysis, sample size
determination

When do you do it?
• Start reading/reviewing early
– What you are planning may already have been done
• Continue throughout the project
• Drawback of an early exhaustive review
– May inhibit originality

How to start?
• Talk to: experts, colleagues, librarian
• Read a textbook, bibliography
• Identify key original papers and review articles
• Key words and MeSH words (Medical Subject
Headings)
• Medline/PubMed
• Google scholar

Published Material
• Books
• Journal articles (original research, review)
• Conference proceedings/abstracts
• Reports
• Dissertations

Sources of Published Material
• Libraries – PGIM, Ministry of Health,
Universities, SLMA, SLAAS, etc.
• Private collections
• Internet/ web resources
Pubmed
http://www.ncbi.nlm.nih.gov/entrez/

Sources of Unpublished Material
• Experts
• Teachers
• Colleagues

@ www.pubmed.com

Learning PubMed is easy as A, B, C…………..
Demonstration videos @ http://www.nlm.nih.gov/bsd/disted/pubmed.html#qt

Identify researchable areas in the problem
State Objectives
General Objective Specific Objectives

Once the research topic is identified
We can proceed with….
Literature review
Identifying/clarifying methodology
Identifying ethical issues etc….

Why do we need objectives for a
research
• To verify the extent of research
• To have a clear guidance on the research
• To focus the research topic to achievable
targets
• To build necessary skills and experiences
needed for the research
• To prepare the research plan ……

Research objectives should be
• S -Specific
• M -Measurable
• A -Achievable
• R -Realistic/ reliable
• T -Time bound

Specific
In both meaning and focus

Measurable
Outcome of the research should be
measurable
Need to identify indicators for measuring

Achievable
Does your resources and capacity
allow you to reach the target

Reliable/Relevance/Realistic
are the resources available reliable to
carryout the research
Are the planed methods correct and
appropriate for the study

Time bound
Am I able to finish this within the
target timeDepartment of Research– NIHS : Inspiring Public Health through Innovative Research

An “objective” starts with
Action verbs
As we are trying to solve a problem or clear up a
situation
Verb is combined with “To”
To describe To recommend
To develop To analyze
To identify To design
To assess To compare

An “objective” includes
What you are going to do specifically
Where you are going to do this OR for whom
you are going to do this for
When you are going to do this
Why you are going to do this is not included
here Department of Research– NIHS : Inspiring Public Health through Innovative Research

Some examples
To describe the patient profile treated at PCU -
BH Panadura during first quarter of 2014.
To estimate the prevalence and selected risk
factors for DM in Hambantota district for 2014.
To describe the knowledge on breast feeding
technique among the pregnant primiparas
females in the MOH area of Hambantota in
2014.

Study Designs
Descriptive studies Analytical studies
Case report
Case serial
reports
Cross-sectional
studies
Ecological
studies
Observational
studies
Experimental
studies
Case-control
studies
Cohort
studies
Prospective
Retrospective
(historical)
Randomized
Controlled Clinical
trials
Randomized
Controlled field
trials
Non-randomized
experiments

General population, study population and the sample

The sampling process…
POPULATION
SAMPLE
INFERENCE

The sampling process…
POPULATION
SAMPLE
INFERENCE
Is this sample representative?

Sample Size Calculation

What is the measure of interest?
What is the underlying probability distribution of the
characteristic of interest?
What is the sampling distribution of the measure?
(i.e., type of study design and how the samples were obtained)
How accurate do the results want to be?

The accuracy of the estimate depends on two
quantities:
1. how narrow the width of interval
2. how confident the results to be(e.g. 95%).

S – Sample size for infinite population
Z 1-α/2 – Percentile of the standard normal distribution determined by the
specified confidence level (1.96 for 95% confidence level)
p – Estimated proportion in study population
d – Acceptable margin of error (width of interval)
Formula to calculate sample size for a cross sectional
study having a binomial distribution for the characteristics
of interest
(i.e., to calculate a proportion of a certain event)

@ http://www.openepi.com/Menu/OE_Menu.htm

Problem identificationProblem identification
& Prioritization& Prioritization
Problem analysisProblem analysis
Literature ReviewLiterature Review
Developing ObjectivesDeveloping Objectives
Study DesignsStudy Designs
Selecting study populationSelecting study population
Sample size calculationSample size calculation
Data Collection TechniquesData Collection Techniques

What is data collection?
• Systematic collection of information about the
Objects of the study and about the settings in
which they occur
• Objects
– People
– Phenomena (Occurrences, Happenings)
– Objects (Things)

What is data collection?
• Data collection need to be Systematic
• Haphazard data collection will not answer the
research question well

Different data collection techniques
• Using available information
• Observing
• Interviewing
• Administering questionnaires
• Observational check list
• Focus Group Discussions / In depth interview
• Other methods

MEASUREMENT

Measurement is
essentially assigning
numbers according to
certain rules

Anything that can
be measured and is
observed to vary is
called a variable
Variable

MEASUREMENT
ERROR
When ever we make
measurements we must be
aware of the possibility of
error

Two kinds of errors
Systematic error
Random error

How to minimize Subject
variation
•Planning data collection in almost
similar settings, environments
•Training data collectors on
questioning (tone, mood, time of the
date etc)

How to minimize observer
error
Training observers or data
collectors (Inter observer
variation)
Repeat measurements and take the
average (Intra observer variation)

How to minimized Instrumental
errors
•Standardizing instruments and
procedures
•Instruments has to standardize/
calibrate repeatedly
•Procedures or techniques has to
be cross check during the study

Characteristics of an indicator
• Valid
• Reliable
• Sensitive
• Specific

Validity
Validity is the ability of a
instrument/ questionnaire
to measure what it suppose
to measure

Reliable
Reliability / Repeatability
is the level of agreement
between two replicate
measurements

Data collection flow
The following needs to be thought of and decided upon……
1.Who is going to collect the data ?
2.From whom ?
3.Where ?
4.How ?
5.Using what?
6.How is information given to the participants?
7.How are they recruited to the study?
8.How is consent to be obtained?
9.How to conclude the data collection?
10.What to do with positive cases?
11.Checking for quality of the collected data? Who? When ? Where ? How ?
12.Entering the data?
13.Analysis of the data

Ethical considerations
– Do no harm
– Do good
– Voluntary participation
– Informed consent
– Conflict of interest
– Scientific validity

@ https://phrp.nihtraining.com/users/login.php

Getting Ethics clearance
Very Very Very important
No publisher is going to publish your work without ERC approval
Essential for getting your research allowance
Forum for Ethics Review Committees of Sri Lanka (FERCSL)
ERC you submit needs to be accredited from FERCSL
Else your proposal will be re channeled for review by MoH
Some of the FERCSL accredited review committees
1. University ERCs
2. NIHS
3. MRI
4. SLMA
5. NHSL

ERU - NIHS: Centre of Excellence in Public Health Research
Time series chart – GANTT Chart
Item description MAR AP
R
MAY JU
N
JU
L
AU
G
SE
P
OC
T
NO
V
DEC
Initial discussion X
Literature review X X
Finalizing methodology X X
Ethical clearance X
Pre testing X X
Data collection proper X X
Data entry X X
Initial analysis X X
Draft report X
Final report submission X
Presentation of findings X

Preparing a budget
Steps in preparing a budget
1.Perform a task analysis and list out the tasks for the study
2.Define the cost categories for each identified task
1. Manpower
2. Machinery
3. Materials
4. Time
3.Decide on the time requirement for each activity
4.Decide who is going to perform each activity and how
much it is going to cost / person / time unit
5.Perform cost estimation for each activity / task
6.Sum cost of activities to get the total cost for the study

Preparing a budget
Steps in preparing a budget
7.Don’t forget to cost for….
• Travelling, food and accommodation of data
collectors
• Refreshments for discussions / meetings
• Translation and typesetting of questionnaires
• Printing of data collection formats
• Data entry and analysis
• Dissemination of results
• Publication of data
• Licensed software

Plan of analysis
Descriptive statistics
Measures of central tendency
Measures of dispersion
Inferential statistics
Statistical significance
Population parameter estimation
Testing of hypothesis
Statistical modeling
What statistical software is going to be used?

Disseminating research evidence into policy
and practice
1. Research reports
2. Abstract presentation: poster or oral
3. Journal articles
4. Advocacy briefs
5. Policy briefs

Report writing
1. Abstracts and key words
2. An introduction including a justification
3. Appropriate review of literature
4. Objectives and methodology
5. Results
6. Discussion
7. Conclusions and recommendations
8. References
9. Annexures

Quiz
• Please complete this short quiz to test and
increase your knowledge of referencing.
…Good Luck !!

Why do we need to reference material that we
use?
1. Avoid accusations of
plagiarism
2. Acknowledge others work
3. Support academic
arguments
4. Prove that you have
researched a topic
5. All of the above
10

No. 5 is correct
It is crucial in academic writing to acknowledge
the work of others in support of your
argument. Plagiarism is a growing problem
and there are disciplinary procedures for
anyone caught plagiarising other people’s
work.

In which case would you need to reference the
source of information?
1. When you copy word for word
a paragraph from a journal
article/book
2. When you copy word for word
a paragraph from a web site
3. When you write in your own
words ideas from a journal
article/book
4. When you write in your own
words ideas from a web site
5. None of these
6. All of the above 10

No. 6 is correct
• It is important to acknowledge any other
person’s ideas/words that you include in your
work, either directly or indirectly. If you do
not make reference to someone else’s
ideas/work you may be accused of passing it
off as your own (plagiarism).

Which style of referencing is usually followed?
1. Harvard
2. Vancouver
3. Endnotes
4. Reference
footnotes
5. Don’t know
10

No. 1 is correct
• Harvard style of referencing, which is the
author/date style is frequently used. Some
journals and publishers continues to use the
Vancouver, or number, style of referencing.

What are the essential elements of a book
reference?
1. Author’s name and title
2. Author’s name, title
and date
3. Title, date and
publisher
4. Author name,
publication date, title,
place of publication
and publisher
5. Don’t know 10

No. 4 is correct
• It is important that you give these required
elements about the books we use as this
makes it easier for someone to find the
edition of the book that you have used.

What are the essential elements of a
journal article reference?
1. Author name and article
title
2. Author name and
journal title
3. Author name, article
title and publication
date
4. Author name, article
title, journal title,
publication date,
volume and issue
number, inclusive page
numbers
5. Don’t know
10

No. 4 is correct
• It is important to include all of these elements so
that someone else can find the article that you have
referred to.
NB. If you are adding a reference to an electronic
journal please refer to the ‘Quoting and Preparing
References’ guidelines.

What must you include in a web site reference that is
different from other references? (Please choose two
options.)
1. Web site author
2. Date accessed
3. Full URL
4. Don’t know
10

No. 2 & 3 are correct
• Materials on the web may be removed. Including the date
that you looked at the website tells other people when the
material was available.
• Including the full URL will direct other people to the correct
web site.

@: www.nihsknowledgehub.com

@ http://wwwn.cdc.gov/epiinfo/7/

@ http://www.mendeley.com/

RESEARCH TEAM

Putting together a team

A research team needs persons capable of………
• Conducting a literature review - Pub med / HINARI
• Referencing and bibliography - Endnote / Mendally / cite fast
• Calculating of sample size - Open epi or Win pepi
• Developing instruments
• Adhering to ethics and getting ERC approval
• Preparation of a research proposal
• Data base development using Epidata
• Data quality assessment
• Performing simple analysis SpSS OR Epi Info
• Writing a research report
– Abstracts
– Policy briefs
– Short report

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How to Conduct Medical Research

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