Study protocolWord下载.docx

Study protocolWord下载.docx

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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 

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'

:

∙Ethicsapprovalandconsenttoparticipate

∙Consentforpublication

∙Availabilityofdataandmaterials

∙Competinginterests

∙Funding

∙Authors'

contributions

∙Acknowledgements

information（optional）

Pleaseseebelowfordetailsontheinformationtobeincludedinthesesections.Ifanyofthesectionsarenotrelevanttoyourmanuscript,pleaseincludetheheadingandwrite'

Notapplicable'

forthatsection.

Ethicsapprovalandconsenttoparticipate

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”.

Availabilityofdataandmaterials

Pleasedonotinclude