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.



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



Identification of the researchIdentification of the research

problem problem FeasibleFeasible

InterestingInteresting

NovelNovel

EthicalEthical RelevantRelevant

( ( FINER FINER ) )



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?



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



Identify the Question

Sources for identifying the question or problem:

Personal experiences

Literature review

Ideas from others



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



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.



Protocol PreparationProtocol Preparation

Title and Investigator Title and Investigator

IntroductionIntroduction

Materials and MethodsMaterials and Methods Ethical ConsiderationsEthical Considerations

LimitationsLimitations

ReferencesReferences Appendices Appendices



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



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



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.



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



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



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



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



Study Design

Characteristics of good study design:

Appropriateness of question

Lack of study bias Precision of study

Power of study



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?




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?




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




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?




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.




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




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?




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



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.



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



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?



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



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



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



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 Úniform requirements for Vancouver style Úniform requirements formanuscript submitted to biomedical journalsµmanuscript submitted to biomedical journalsµ

Ínternational Committee of Medical JournalÍnternational 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



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 ín pressµ and submitted but not yetbe cited as ín pressµ and submitted but not yet

accepted should be cited as Únpublishedaccepted should be cited as Únpublished

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.



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



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 provide the backbone

of the ultimate research paper



T h ank y ou T h ank y ou

Writing a Research Protocol

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