Study protocol.docx
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Study protocol.docx
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Studyprotocol
Studyprotocol
Criteria
Studyprotocolarticleswillgenerallyonlybeconsideredforproposedorongoingtrialsthathavenotcompletedparticipantrecruitmentatthetimeofsubmission. Trials advisesthatstudyprotocolsaresubmittedwellbeforerecruitmentcompletes,howeverwewillalsoonoccasionconsiderstudyprotocolssubmittedbeforethelastpatient/lastvisit.This,includinganexplanationofwhyitwasnotpossibletosubmitearlier,shouldbeincludedwithinthemanuscripttext.Pleaseconfirmthestatusofyourstudyatsubmission.
Pleasenote:
From1stJanuary2021, Trials willnolongerconsiderstudyprotocolsforpilotorfeasibilitytrialsforpublication.Werecommendthatthesemanuscriptsareinsteadsubmittedtooursisterjournal, PilotandFeasibilityStudies.
Trials alsoconsidersstudyprotocolsassessingaspectsofthedesign,conductorreportingofrandomizedtrials.Thesestudiesdonotnecessarilyneedtobetrialsandincludestudiessuchascoreoutcomesetdevelopmentforuseintrialsandprocessevaluationsthatrunalongsidetrials.Pleasefollowthe relevantreportingguideline forthestudydesignandincludethecorrespondingchecklistasanadditionalfile.Theonlineprotocoltemplatecalled SEPTRE(SPIRITElectronicProtocolTool&Resource) isaweb-basedoptiontocreate,manage,andregisterprotocolsusingtheSPIRITguidance.
Allsubmittedprotocolsmusthaveethicalapproval.Ifthestudyhasundergonefullexternalpeerreviewaspartofthefundingprocess,thestudyprotocolwillusuallyonlyundergoeditorialpeerreviewbyaProtocolEditor.Studyprotocolswithoutmajorexternalfundingwillundergofull,externalpeerreview.Studyprotocolswithoutethicalapprovalwillgenerallynotbeconsidered.Tosupportefficienthandlingofyourstudyprotocol,theEditorsadvisethatprospectiveauthorsfamiliarizethemselveswiththis Editorialonwhatisexpectedinastudyprotocolsubmission.
AdditionalFiles
Onsubmission,thefollowingdocumentationshouldbeuploadedasAdditionalFiles.IftheoriginaldocumentsarenotinEnglish,anEnglishtranslationofeachismandatory.
∙Ethicalapprovaldocument
∙Copyoftheoriginalfundingdocumentation
∙AcompletedSPIRITchecklist(unlessthe structuredstudyprotocoltemplate hasbeenused),orchecklistforanotherappropriatereportingguideline
SPIRITGuidance
Studyprotocolsreportingaclinicaltrialcanbeformattedforsubmissionto Trials intwoways:
1.Byfollowingtheguidancesetoutinour structuredstudyprotocoltemplate.Thisisthepreferredoptionifyouhavenotyetstartedwritingyourmanuscript.
2.BysubmittingapopulatedSPIRITchecklist(i.e.pageandlinenumbersnexttoeachitemcorrespondingtowhereitisfoundwithintheprotocol)andSPIRITfigurealongsideyourmanuscript.TheSPIRIT2013Statement,33-itemchecklistandfigurecanbedownloadedhere.Thefigureshouldbeincludedinthemainbodyofthetextandthechecklistshouldbeprovidedasan additionalfile,boththefigureandthechecklistshouldbereferencedinthetext.Submissionsreceivedwithouttheseelementswillbereturnedtotheauthorsasincomplete.
ItisunderstoodthatforsomestudyprotocolscertainaspectsmaynotcomplyfullywitheachitemoftheSPIRITStatement.Ifused,thechecklistwillnotbeusedasatoolforjudgingthesuitabilityofmanuscriptsforpublicationin Trials,butisintendedasanaidforauthorstoclearly,completely,andtransparentlyletreviewersandreadersknowwhatauthorsintendtodo.Whereanitemisnotapplicable,authorscanstatethisbutmustalsoaddabriefexplanationastowhytheitemisnotapplicable.Eg. BiologicalSpecimens,Itemno.33:
Notapplicable,nosamplescollected. Simplysaying’N/A’willleadtothemanuscriptbeingreturned.AcompletedSPIRITchecklistshouldlooklike this.Likewise,ifthestructuredprotocoltemplateisused,pleasefollowtheguidancebyleavingallheadings,identifiersandcurlybracketsintheordergivenandprovideacompleteresponseundereach.Acompleteexamplecanbefound here.
InReview
AuthorssubmittingtoTrialscannowopt-intoaservicecalled InReview,whichprovidesapre-printservice,meaningthearticlecanbesharedwithfundersandothersinaciteablewaywhileitisunderreview.Italsoprovidesauthorswithon-demandinformationonthestatusoftheirmanuscript,enablesthemtosharetheirworkwithfundersandothers,andallowstheirwidercommunitytocommentandcollaborate-allwhilsttheirmanuscriptisunderreview.Pleaseseehereforfulldetails.
Preparingyourmanuscript
Theinformationbelowdetailsthesectionheadingsthatyoushouldincludeinyourmanuscriptandwhatinformationshouldbewithineachsection.
Pleasenotethatyourmanuscriptmustincludea'Declarations'sectionincludingallofthesubheadings(pleaseseebelowformoreinformation).
Titlepage
Thetitlepageshould:
∙presentatitleincludinginformationaboutthestudydesign,population,interventions,and,ifapplicable,trialacronym,usingthefollowingformat“___________:
studyprotocolfora___________trial.”
∙listthefullnames,institutionaladdressesandemailaddressesforallauthors
oifacollaborationgroupshouldbelistedasanauthor,pleaselisttheGroupnameasanauthor.IfyouwouldlikethenamesoftheindividualmembersoftheGrouptobesearchablethroughtheirindividualPubMedrecords,pleaseincludethisinformationinthe“Acknowledgements”sectioninaccordancewiththeinstructionsbelow
∙indicatethecorrespondingauthor
Abstract
TheAbstractshouldnotexceed350words.Pleaseminimizetheuseofabbreviationsanddonotcitereferencesintheabstract.Theabstractmustincludethefollowingseparatesections:
∙Background:
thecontextandpurposeofthestudy
∙Methods:
howthestudywillbeperformed
∙Discussion:
abriefsummaryandpotentialimplications
∙Trialregistration:
Ifyourarticlereportstheresultsofahealthcareinterventiononhumanparticipants,itmustberegisteredina WHOICRTPregistry.Thenameoftheregistry,registrationnumberanddateofregistrationshouldallbestatedinthissection.Ifitwasnotregisteredprospectively(beforeenrollmentofthefirstparticipant),youshouldincludethewords'retrospectivelyregistered'.Seeoureditorialpoliciesformoreinformationontrialregistration.
Keywords
Threetotenkeywordsrepresentingthemaincontentofthearticle.
Background
TheBackgroundsectionshouldexplainthebackgroundtothestudy,itsaims,asummaryoftheexistingliteratureandwhythisstudyisnecessaryoritscontributiontothefield.
Methods/Design
Themethodssectionshouldinclude:
∙theaim,designandsettingofthestudy
∙thecharacteristicsofparticipantsordescriptionofmaterials
∙acleardescriptionofallprocesses,interventions,comparisonsanddetailsoftherandomizationprocess.Genericdrugnamesshouldgenerallybeused.Whenproprietarybrandsareusedinresearch,includethebrandnamesinparentheses
∙thetypeofstatisticalanalysisused,includingapowercalculationifappropriate.
Discussion
Thisshouldincludeadiscussionofanypracticaloroperationalissuesinvolvedinperformingthestudyandanyissuesnotcoveredinothersections.
Trialstatus
Authorsshouldreporttheprotocolversionnumberanddate,thedaterecruitmentbegan,andtheapproximatedatewhenrecruitmentwillbecompleted.
Listofabbreviations
Ifabbreviationsareusedinthetexttheyshouldbedefinedinthetextatfirstuse,andalistofabbreviationsshouldbeprovided.Pleasetrynottoincludetoomanyunnecessaryacronymsandabbreviationswithinthetext.Ifthishindersthelegibilityofthemanuscript,youmaybeaskedtoremovethesebytheEditor.
Declarations
Allmanuscripts must containthefollowingsectionsundertheheading'Declarations':
∙Ethicsapprovalandconsenttoparticipate
∙Consentforpublication
∙Availabilityofdataandmaterials
∙Competinginterests
∙Funding
∙Authors'contributions
∙Acknowledgements
∙Authors'information(optional)
Pleaseseebelowfordetailsontheinformationtobeincludedinthesesections.Ifanyofthesectionsarenotrelevanttoyourmanuscript,pleaseincludetheheadingandwrite'Notapplicable'forthatsection.
Ethicsapprovalandconsenttoparticipate
Trials donotconsiderstudyprotocolsforstudieswithoutethicalapproval.YouwillberequiredtoprovideacopyoftheoriginalethicalapprovaldocumentandanEnglishtranslationofthisdocumentasanadditionalfileonsubmission,whichwillbecheckedagainstthisdeclaration.Thenameoftheethicscommitteethatapprovedthestudyandthecommittee’sreferencenumber(ifapplicable)shouldbedeclared.Detailsofauthors’intentionstoobtainconsenttoparticipateinthestudyfromparticipants(ortheirparentorlegalguardianinthecaseofchildrenunder16)shouldbedeclared.“eg. ABCEthicalReviewBoardABC123456.Written,informedconsenttoparticipatewillbeobtainedfromallparticipants”
Moreinformation
Consentforpublication
Pleasedonotincludeanybaselineorpilotdatainyourstudyprotocol.TheEditorialOfficewillaskyoutoremovethisifitisincluded.Ifyouhaveincludedanydetails,imagesorvideosrelatingtoanindividualperson,writteninformedconsentforthepublicationofthesedetailsmustbeobtainedfromthatperson(ortheirparentorlegalguardianinthecaseofchildrenunder18)anddeclaredinthissection.Pleasealsostatewhetheryouwillbewillingtoprovideamodelconsentformonrequest.Ifthissectiondoesnotapply,pleasestate“Notapplicable”.
Moreinformation
Availabilityofdataandmaterials
Pleasedonotinclude
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