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 EvaluationWHO 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

HousingAge, 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 sectora) 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


Problem analysis

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


http://www.wikimindmap.org/

Literature review

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


http://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


http://www.google.lk/imgres?hl=en&biw=1438&bih=686&tbm=isch&tbnid=q0K6tT0RrmODhM:&imgrefurl=http://betterpractice.org/index.php/improving-employee-performance-and-job-satisfaction/&docid=-6Ftv-WDcOcCeM&imgurl=http://www.torbenrick.eu/blog/wp-content/gallery/performance/ball-target.jpg&w=800&h=600&ei=OxHRUbGrCsPirAe834CgAQ&zoom=1&ved=1t:3588,r:34,s:0,i:194&iact=rc&page=2&tbnh=188&tbnw=236&start=12&ndsp=24&tx=64.78955078125&ty=93.5263671875

Measurable

Outcome of the research should be measurable

Need to identify indicators for measuringDepartment of Research– NIHS : Inspiring Public Health through Innovative Research

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 time


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 Department of Research– NIHS : Inspiring Public Health through Innovative Research

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 serialreports

Cross-sectionalstudies

Ecological studies

Observational studies

Experimentalstudies

Case-controlstudies

Cohort studies

Prospective Retrospective(historical)

RandomizedControlled Clinical

trials

RandomizedControlled field

trials

Non-randomizedexperiments


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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 thecharacteristic 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 identification Problem identification & Prioritization& Prioritization

Problem analysisProblem analysis

Literature ReviewLiterature Review

Developing ObjectivesDeveloping Objectives

Study DesignsStudy Designs

Selecting study populationSelecting study populationSample 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

errorDepartment of Research– NIHS : Inspiring Public Health through Innovative Research

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


Valid

& reliable

Valid

Not as reliable

Not valid

Repeatable

Not valid

Not reliable

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 importantNo 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 FERCSLElse your proposal will be re channeled for review by MoH

Some of the FERCSL accredited review committees

1. University ERCs2. NIHS 3. MRI4. SLMA5. NHSL


ERU - NIHS: Centre of Excellence in Public Health Research

Time series chart – GANTT ChartItem description MAR AP

RMAY JU

NJUL

AUG

SEP

OCT

NOV

DEC

Initial discussion XLiterature review X XFinalizing methodology X XEthical clearance XPre testing X XData collection proper X XData entry X XInitial analysis X XDraft report XFinal report submission XPresentation of findings X


Preparing a budget Steps in preparing a budget

1.Perform a task analysis and list out the tasks for the study2.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 above10


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 these6. 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 know10


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 title2. Author’s name, title

and date 3. Title, date and

publisher4. 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 know10


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.comDepartment of Research– NIHS : Inspiring Public Health through Innovative Research

@ 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


Together Everyone Achieves More


Thank you

how to conduct medical research

Health & Medicine

innovative research

inspiring public health

health system

world health organization

systematic approach

systematic investigation

old facts

new york