writing a research protocol
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WRITING A RESEARCH WRITING A RESEARCH
PROTOCOLPROTOCOL
Dr.B.Unnikrishnan,Dr.B.Unnikrishnan,
Professor & Head,Professor & Head,
Dept of Community Medicine,Dept of Community Medicine,
Kasturba Medical College , Mangalore.Kasturba Medical College , Mangalore.
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Steps in Research
Identify the question or problem
Conduct a literature review of the question
Frame a hypothesis Develop the study design
Complete the research
Analyze the data Generate conclusions
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Identification of the researchIdentification of the research
problem problem FeasibleFeasible
InterestingInteresting
NovelNovel
EthicalEthical RelevantRelevant
( ( FINER FINER ) )
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Study questionStudy question The protocol should start with a clear and The protocol should start with a clear andprecise formulation of the researchprecise formulation of the research
question. It is good practice to write thisquestion. It is good practice to write thisin the form of a question, not a statementin the form of a question, not a statement
Example: Example:
W hy is asthma among children in W hy is asthma among children in
Mangalore exceptionally frequent?Mangalore exceptionally frequent?
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Identify the Question
Good or poor research is defined by the
question being asked.
The question should be well understood, and
the problem well defined.
If the question is hurried, proceeding in anorderly fashion may be difficult and may
produce unreliable results
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Identify the Question
Sources for identifying the question or problem:
Personal experiences
Literature review
Ideas from others
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Literature Review Literature Review
How much the same or similar research problemHow much the same or similar research problem
has been studied previously has been studied previously
To understand the limitations in those studies To understand the limitations in those studies To critically assess the required modifications To critically assess the required modifications
which could provide some new knowledge which could provide some new knowledge
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Literature Review
Primary Sources:
Journal articles, books, abstracts
W ritten by the person( s) who conductedthe research
Secondary Sources:
Review articles that summarize research
W ritten by someone other than primary investigator.
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Protocol PreparationProtocol Preparation
Title and Investigator Title and Investigator
IntroductionIntroduction
Materials and MethodsMaterials and Methods Ethical ConsiderationsEthical Considerations
LimitationsLimitations
ReferencesReferences Appendices Appendices
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Title & Investigator Title & Investigator
Short but informativeShort but informative
Convey the main objectives, population & if Convey the main objectives, population & if
possible study designpossible study design
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IntroductionIntroduction
Provide logical & Scientific justificationProvide logical & Scientific justification
Describe precisely the magnitude and quantumDescribe precisely the magnitude and quantum
of knowledge available regarding the problemof knowledge available regarding the problem Identify the gaps & controversies in the existing Identify the gaps & controversies in the existing
knowledgeknowledge
Should be as brief as possibleShould be as brief as possible
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ObjectivesObjectives
Even a precise study question is often tooEven a precise study question is often toobroad for one study to answer, like ´broad for one study to answer, like ´Why is Why is
a sth ma among chi ldren i n M angalore ex c epti onall y a sth ma among chi ldren i n M angalore ex c epti onall y
f requen t? f requen t? µ You must therefore break down theµ You must therefore break down thequestion into several objectivesquestion into several objectives..
Example: Example:
The objectives of this study are to determine if the excess The objectives of this study are to determine if the excessasthma in Mangalore is related to a combination of geneticasthma in Mangalore is related to a combination of geneticdisposition ( estimated by atopic status) and socioeconomicdisposition ( estimated by atopic status) and socioeconomicstatus and / or air pollution.status and / or air pollution.
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ObjectivesObjectives
One should be able to achieve it within aOne should be able to achieve it within a
reasonable time.reasonable time.
Should be simple, clear, specific and measurableShould be simple, clear, specific and measurable Number of objectives should be limitedNumber of objectives should be limited
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Materials andMethodsMaterials andMethods
oo Study designStudy design
oo Study populationStudy population
oo Sample size and statistical powerSample size and statistical power
oo Subjects: selection and definitionsSubjects: selection and definitions
oo Data collection methods: measurements,Data collection methods: measurements,definitionsdefinitions
oo Data management and statistical analysisData management and statistical analysis
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Study designStudy design
This should state the selected design of This should state the selected design of
the study. Keep in mind that the studythe study. Keep in mind that the studydesign is chosen in relation to studydesign is chosen in relation to study
objectives.objectives.
Explain why the particular study designExplain why the particular study design
has been chosen in preference to otherhas been chosen in preference to other
possible designs possible designs
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Study Design
A study design is the researcher·s overall plan
to obtain the answer's to the question being
asked and the hypothesis being tested It spells out strategies to develop information
that is accurate, objective and meaningful
It explains methods that will be used to collect
and analyze data
It includes time frame to conduct study
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Study Design
Characteristics of good study design:
Appropriateness of question
Lack of study bias Precision of study
Power of study
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Materials &MethodsMaterials &Methods
Study populationStudy population
This section outlines the setting for which the This section outlines the setting for which the
research has relevanceresearch has relevance
Example: Example:
oo Which children inMangalore should we study? Which children inMangalore should we study?
oo Can the study results be extrapolated?Can the study results be extrapolated?
oo What is the definition of ´childµ? What is the definition of ´childµ?
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Materials &MethodsMaterials &Methods
Sample size and statistical powerSample size and statistical powerSpecify assumptions and provide tables of Specify assumptions and provide tables of
sample size and power calculationsample size and power calculation
Example: Example: oo How many children will be recruited?How many children will be recruited?
oo What proportion of the population is included? What proportion of the population is included?
oo Will the number of children be sufficient? Will the number of children be sufficient?
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Materials &MethodsMaterials &Methods
Subjects: selection and definitionsSubjects: selection and definitions
This section should provide: This section should provide:
oo A detailed explanation of how many subjects in each A detailed explanation of how many subjects in each
category will be recruited and whycategory will be recruited and why
oo Definitions of eligibility, inclusion and exclusionDefinitions of eligibility, inclusion and exclusion
oo Realistic estimates of the number eligible subjectsRealistic estimates of the number eligible subjects
oo Description of recruitment mechanismDescription of recruitment mechanism
oo Discussion of recruitment feasibilityDiscussion of recruitment feasibility
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Materials &MethodsMaterials &Methods
Example: Example:
oo Will children with (without) asthma be included? Will children with (without) asthma be included?
oo Which children will be excluded? Which children will be excluded?oo How will the children be approached?How will the children be approached?
oo What will you do when they decline? What will you do when they decline?
oo How many children will be eligible and whatHow many children will be eligible and what percentage do you expect will actually participate? percentage do you expect will actually participate?
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Materials &MethodsMaterials &Methods
Data collection methods: definitions and measurementsData collection methods: definitions and measurements
It is essential to state how the data will be collected toIt is essential to state how the data will be collected to
determine both the health outcomes and thedetermine both the health outcomes and the
determinants you are planning to study.determinants you are planning to study.
This means specifying exactly how these will be This means specifying exactly how these will be
measured or definedmeasured or defined i n th e propos ed st ud y i n th e propos ed st ud y ..
Quality control procedures should be specified.Quality control procedures should be specified.If the procedure is a standard one that has beenIf the procedure is a standard one that has been
described before, it should be referenced.described before, it should be referenced.
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Materials &MethodsMaterials &Methods
Data collection methods: definitions andData collection methods: definitions and
measurementsmeasurements
This includes: This includes:
oo Precise definitions of all termsPrecise definitions of all terms
oo Consideration of pilot testing for methodsConsideration of pilot testing for methods
and instrumentsand instruments
oo Discussing the validity and reliability of theDiscussing the validity and reliability of thedefinitions proposeddefinitions proposed
oo Discussing the limitations of theDiscussing the limitations of the
measurement tools and definitions proposedmeasurement tools and definitions proposed
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Materials &MethodsMaterials &Methods
Example: Example:
oo How will the presence of asthma be determined?How will the presence of asthma be determined?
oo What will happen if someone who doesn·t have What will happen if someone who doesn·t haveasthma is said to have it?asthma is said to have it?
oo What is the definition of indoor pollution? What is the definition of indoor pollution?
oo Which components of indoor pollution will be Which components of indoor pollution will beevaluated?evaluated?
oo How will socioHow will socio--economic status be determined?economic status be determined?
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Materials &MethodsMaterials &Methods
Data: management and analysisData: management and analysis
oo Procedures for coding and data entryProcedures for coding and data entry
oo Measures to ensure completeness andMeasures to ensure completeness and
accuracyaccuracy
oo Examples of data presentation andExamples of data presentation andcomparisonscomparisons
oo Formal hypothesis testingFormal hypothesis testing
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Strengths and LimitationsStrengths and LimitationsIssuesIssues
oo Compromises have to be made in designCompromises have to be made in design
oo There is no ´perfect protocolµ: provide a section There is no ´perfect protocolµ: provide a section
discussing areas open to criticism; providediscussing areas open to criticism; provide
reasoning for accepting limitations.reasoning for accepting limitations.
Provide a section on particular strengths of theProvide a section on particular strengths of thestudy design.study design.
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Ethical ConsiderationsEthical Considerations This section must explicitly state that the study This section must explicitly state that the study
takes the principles of the Helsinki declarationtakes the principles of the Helsinki declaration
into account. It indicates:into account. It indicates:
oo How the quality of technical aspects is ensuredHow the quality of technical aspects is ensured
oo The expected hazards and benefits The expected hazards and benefitsoo The rational and justification for the research The rational and justification for the research
oo The priority of participants· interest The priority of participants· interest
oo Responsibility for liability for injuryResponsibility for liability for injury
oo How participants are informed about studyHow participants are informed about study
oo How participants give consent for enrolmentHow participants give consent for enrolment
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Ethical ConsiderationsEthical Considerations Example: Example:
oo Will any child be at risk from a reaction to the Will any child be at risk from a reaction to the
allergy skin tests?allergy skin tests?
oo Who will provide consent for the child to Who will provide consent for the child to
participate? participate?
oo Who will know about the results of the Who will know about the results of the
examinations?examinations?oo What will be done if disease is found? What will be done if disease is found?
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Overall ProjectManagementOverall ProjectManagementP
er s onnel P
er s onnel required andrequired and ti mel i ne ti mel i ne including:including:oo Pilot testingPilot testing
oo Recruiting of subjectsRecruiting of subjects
oo Preparation of forms and questionnairesPreparation of forms and questionnairesoo Data collectionData collection
oo Follow Follow--up proceduresup procedures
oo Data checking an statistical analysesData checking an statistical analyses
oo ReportingReporting ² ² to participants, community,to participants, community,
academic communityacademic community
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Investigators: role of each andInvestigators: role of each andc urr ic ulum vit ae c urr ic ulum vit ae Define here the role each investigator plays in the studyDefine here the role each investigator plays in the study
and state responsibilities.and state responsibilities.
Determine best here authorship of any publicationsDetermine best here authorship of any publications
The CV should provide description of qualification The CV should provide description of qualification
and expertise, training, degrees, scientific publicationsand expertise, training, degrees, scientific publications
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BudgetBudget
Each item of expenditure must be specifiedEach item of expenditure must be specified
Expenditures should, to the extent possible, be given inExpenditures should, to the extent possible, be given inunits (such as salarial costs per hour, day, week)units (such as salarial costs per hour, day, week)
A written budget justification is usually required if the A written budget justification is usually required if the
study has external sponsorsstudy has external sponsors
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ReferencesReferences
Statement of facts quoted in the protocol mustStatement of facts quoted in the protocol must
be referencedbe referenced
Accepted style of writing references is the Accepted style of writing references is the Vancouver style ´Uniform requirements for Vancouver style ´Uniform requirements formanuscript submitted to biomedical journalsµmanuscript submitted to biomedical journalsµ
´International Committee of Medical Journal´International Committee of Medical JournalEditors ( ICM JE)µ accepted by more than 400Editors ( ICM JE)µ accepted by more than 400
International medical journalsInternational medical journals
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S al i en t f ea t ure o f V an c ou v er S ty le S al i en t f ea t ure o f V an c ou v er S ty le
Number the reference consequently in the orderNumber the reference consequently in the order
mentioned in the documentmentioned in the document
Title of the journal should be abbreviated Title of the journal should be abbreviated
according to the style used in Index medicusaccording to the style used in Index medicus
The references accepted but not published must The references accepted but not published must
be cited as ´in pressµ and submitted but not yetbe cited as ´in pressµ and submitted but not yet
accepted should be cited as ´Unpublishedaccepted should be cited as ´Unpublished
observationsµobservationsµ
List all authors , but if the number exceeds six ,List all authors , but if the number exceeds six ,
give six followed by et al.give six followed by et al.
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Appendices Appendices
Letters of approval (if required)Letters of approval (if required)
Questionnaire or data collection instrumentQuestionnaire or data collection instrument
Informed consent (If required)Informed consent (If required) Time task chart Time task chart
BudgetBudget
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The research protocol contains all elements except
study results and their discussion that will also pro-vide the backbone of the ultimate research paper
The research protocol contains
all elements except studyresults and their discussion that
will also pro- vide the backbone
of the ultimate research paper
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T h ank y ou T h ank y ou