Research protocol & Systematic Review

1. Systematic Review Research Protocol
1. Focusedona single question
2. Includesapeerreviewprotocol or
plan
3. Providessummariesof the
available literature onatopic.
4. Clearobjectivesare identified
5. inclusion& exclusionCriteriais
statedbefore reviewis conducted.
6. SearchStrategyis Comprehensive
searchconductedina systematic
way.
7. Processusuallyclearandexplicit.
8. Comprehensiveevaluationof study
quality.
9. Clearsummariesbasedonhigh
qualityevidence.
10. Writtenbyan expertor groupof
expertswith adetailedandwell
groundedknowledge of the issues
1. Planning&definingresearchproblem
2. Review of literature
3. Developmentof workinghypothesis
/researchquestion
4. conciseobjectivesare identified.
5. The inclusioncriteriaidentifythe study
populationinaconsistent,reliable,
uniformandobjective manner. The
exclusion criteria include factors or
characteristics that make the
recruited population ineligible for the
study.
6. A search strategy is an organised
structure of key terms used to
search a database. The search
strategy combines the key concepts
of your search question in order to
retrieve accurate results.
7. Synthesisis aprocessof bringing
togetherdatafrom a setof included
studieswiththe aimof drawing
conclusionsaboutabodyof evidence
8. The actual writingof a Research
protocol isa teameffortwith
contributionsfromamedical expert,a
statistician,apharmacokineticsexpert,
the clinical researchcoordinator, and
the projectmanager,whoall provide
inputto the medical writertoproduce
the final document.
Research Protocol Systematic review
Definition:A researchprotocol isa document
that describesthe Studyof objectives,design,
methodology,statistical evaluationof the data,
and organizationof aclinical Trial.
Definition: Systematicreviewsfollow a
rigorousscientificprocessittakesmore thana
few stepstocomprehensivelygathercombine
and evaluate existingevidence firstmake sure
you're askingyourquestionsinthe rightway
it's possible
Purpose: The purposeof the researchprotocol
isto developyourideas,arobustmethodology
and a clearguide that can be referredto
throughoutyourstudy,andit providesbasisfor
productionof anyfinal reportsand
publications.
Purpose: The purposeof asystematicreview
isto deliverameticuloussummaryof all the
available primaryresearchinresponse toa
researchquestion.A systematicreview usesall
the existingresearchandissometimecalled
'secondaryresearch'(researchonresearch).

2. Importance:Inclinical research,the research
protocol isof particularimportance as it serves
as the bindingdocumentthat states what you
are—andare not—allowedtostudy. Your
researchprotocol will alsobe the most
importantdocumentinyourapplicationwith
your institution'sreview board(IRB)
Importance:Systematicreviewsaimtoidentify,
evaluate,andsummarize the findingsof all
relevantindividual studiesoverahealth-related
issue,thereby makingthe available evidence
more accessible todecisionmakers
Steps for writing a research protocol:
1. Componentsof aresearchprotocol.
2. Title andabstract.
3. IntroductionaimsandObjectives.
4. Context-review of relevantliterature
5. Methodology-researchQuestions,
StudyDesign,descriptionof
Methodology,Planof Analysis.
6. References:Citations,CitingStyles,
citinggenerals,books,Internet
References
Steps for writing a systematicreview
1. Formulate a research question.
Consider whether a systematic
review is needed before starting
your project.
2. Develop research protocol.
3. Conduct literature search.
4. Select studies per protocol.
5. Appraise studies per protocol.
6. Extract data.
7. Analyse results.
8. Interpret results
Research protocol:
Successof any processdependsonhowwell itisplanned.
Clinical trial isaComplex processneedSystematicplanningfora Fruitful Outcome.
Researchprotocol playsanimportantrole indefiningthe actionplanof anyinvestigation.
Researchprotocol Describe Howclinical trial tobe conducted
It clearlyExplainsthe researchQuestions andthe stepsinvolvedtothe ResearchQuestion
A researchprotocol isa documentthatdescribesthe Studyof objectives,design,methodology,
statistical evaluationof the data,andorganizationof a clinical Trial.
Background:
• Backgroundof the current problem/issue/disease beingstudied

3. • Magnitude of the problem/issue/disease
•Approximatelyone page
Literature review
• It allowsthe researchertobecome familiarwithwhatisalreadyknownaboutthe problemand
aware of bothsupportingandopposingpointof view
• Pastresearchprovidesusefulinformationonprevioustestedhypothesis,operational definitions,
data collectioninstruments,andresearchdesignpertinenttothe researchproblem
The reviewshouldbe organizedbydiscussingthe
1. International studies
2. Regional studies
3. Local literature
•Approximately2pages.
Rationale of the study
• What isnot yetknownandwhat are the still unansweredquestionsrelatedtothe topicand why
YOUR studyisimportantandwhat itadds to the currentpool of knowledge
• One paragraph
Aims and objectives
• State the researchobjectivesinclearmeasurable terms
• To studythe effectsof earlymobilizationwithin72hours of onsetinimprovingfunctional
outcomesafteracute ischemicstroke.
Study Design
• Simplymentionthe studydesign
• Noneedof any clarification/explanationorjustification
• Shouldbe accurate and representative.
Settings
• State the place where the studywill be conducted
• CommunitybasedorHospital
• In-patient/ Outpatient
• Single center/Multi-cente
Studypopulation
• Clearlyexplainthe studypopulation
• Mentionthe inclusionandexclusioncriteria
Sample size

4. • Showcalculationsonhowsample size wascalculated,usingwhichsoftware andatwhat
confidence level.
•Give reference tothe article whichwasusedforcalculations
Sampling technique
• Mentionthe samplingtechnique
• Explainindetail howthe sample will be drawnDatacollectionprocedure.
Data collection procedure
• Mentionthe detailedstepsof the datacollectionprocedure.
• Howand by whomselectedparticipantswill be approached
• Howthisstudy’sobjectiveswillbe explainedtohim/herwithpotential benefitsanddiscomforts.
• Howinformedconsentwillbe obtained( verbal/written) .Minorparticipants?
• Howwill the databe obtained?Paperand penor electronic
• Howwill the datastored?
• Data security
Systematic reviews:
Systematicreviewsfollow arigorousscientificprocessittakesmore thana few stepsto
comprehensivelygathercombineandevaluate existingevidencefirstmake sure you're askingyour
questionsinthe rightwayit'spossible.
your questionsare toobroadso manypeople have triedtoansweryourquestionsinsomanyways
that you'll nevergatherall the evidence ormaybe yourquestionsare toonarrow and there'sno
researchor not enoughresearchtosynthesize
First step
prepare your topic take a quicklookat the available evidence tomake sure there'senoughresearch
to addressyourquestionthencrafta questionthat'sclearandspecificenoughtohelpyoudecide
whatkindof studiesshouldandshouldn'tbe includedinyoursearch
step 2
search for studiesyou'll goto electronicdatabasestofindpublishedarticlesrelatedtoyourquestion
but to findall of the evidence relatedtoyourquestionsyoumighthave tolookinsome
unconventional places.
step 3
screenyour studies in thisstepyoutake a careful lookatwhat you've gatheredremovingevidence
that doesn'tansweryourquestionorhasresearchmethodsyouwantto avoidonce you've sippedit
throughall your evidence it's
step 4
extract the data take the evidence that'sleftandpull outthe informationthatwillhelpyouanswer
your question.Once the datahave beenextractedyouwill needtocarefullycombine andanalyse
whatyou've found.

5. step 5
Analyse and synthesize
If you're conductingmeta-analysisthisiswhere you'll use statistical toolstocombine yourdatayou'll
alsolookat your studiestoevaluate the qualityof the researchandcheckfor biasonce everythingis
preparedyou'll combine all of yourevidence togethertosummarize theirresearchthataddresses
your question
step 6
Report your findings once you've decidedwhatthe evidence hastosayabout yourquestionturn
your conclusionsintoareportthat describesthe stepsyoutookandwhatyoudiscoveredthenshare
it withanyone whocaresaboutyour