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首页 Bronchiolitis RCT.doc

Bronchiolitis RCT.doc

Bronchiolitis RCT.doc

上传者: 你在想我的时候还在想谁 2017-09-20 评分 5 0 205 28 934 暂无简介 简介 举报

简介:本文档为《Bronchiolitis RCTdoc》,可适用于高等教育领域,主题内容包含BronchiolitisRCTCONSENTFORMARANDOMIZEDCONTROLLEDTRIALOFNEBULIZEDEPINEPHRIN符等。

BronchiolitisRCTCONSENTFORMARANDOMIZEDCONTROLLEDTRIALOFNEBULIZEDEPINEPHRINEANDORALDEXAMETHASONEINTHETREATMENTOFOUTPATIENTSWITHBRONCHIOLITISPrincipalInvestigator:DrSandraWhitehouseContactnumber:(oncallstudyinvestigatoravailablehoursperdayanddaysperweek)urposeoftheStudy:PWearecurrentlystudyingthebestwayoftreatingbronchiolitisintheemergencydepartmentBronchiolitisisaviralillnessthatisverycommonduringthewintermonthsYoungchildrenthatdevelopbronchiolitishavecough,difficultybreathingandnoisybreathing(wheezing)foruptoseveralweeksAcrossCanadastudyofchildren’shospitalsshowedthatthetreatmentusedvariessignificantlyateachhospitalWhileseveralmedicationshavebeentriedintreatingbronchiolitis,itremainsunclearastowhich,ifanymedications,canimproveyourchildsymptomsSomephysiciansbelievethatamedicationcalledepinephrine(giveninamistformbyafacemask)mayhelpwithbronchiolitisbydilatingtheairwaysandreducingswellinginsidetheairwaysHowever,whilesomestudieshaveshownthatitmayhelptemporarilyinimprovingachild’sbreathing,otherstudieshaveshownnobenefitPhysicianshaveoftenwonderedwhetheranothertypeofmedication,oralsteroids,mayhelpwithbronchiolitissymptoms,butuntilonesmallrecentstudytherehasbeenalmostnoevidencethattheyhelpinbronchiolitisManyphysiciansquestionwhetheranymedicationsarebeneficialintreatinginbronchiolitisInordertoclearlydecideifeitherofthesetwomedicationsarebeneficialintreatingbronchiolitis,eightchildren’shospitalsacrossCanadaareparticipatinginthisyearstudyWeplantoenrollchildrenintothestudyovertheyearperiodYouhavebeenapproachedtoparticipateinthisstudybecauseyourchildisaged>weeksandlessthanyearandhasrespiratorydistresssuggestiveofbronchiolitisChildrenexcludedfromthestudyarethosewithasthma,chronicdiseases,recentsteroidmedicationuse,andcontactwithchickenpoxThisstudyissponsoredbytheCanadianInstitutesofHealthResearch,agovernmentagencythatfundshealthresearchinCanadaStudyProcedureWhatfollowsisadescriptionofthestudyprocedureIf,afterreadingit,youhaveanyquestionsatall,pleaseasktheresearchcoordinatortoexplainmorefullyIfyouagreetoyourchild’sparticipationinthisstudyyourchildwillreceivetwofacemasktreatmentsminutesapartthatcontaineitherepinephrineoraplacebo(asolutionthatdoesnotamedication)Yourchildwillalsoreceiveonedoseofdexamethasone(steroidmedicinebymouth)followingbymoredaysofdexamethasoneathomeORaplacebointheemergencydepartmentandfollowedbymoredaysofplaceboathomeNeitheryou,northestudynurseoremergencyphysician,willknowwhetheryourchildreceivedamedicationorplacebos(thisisknownas“blinding”)However,iftheemergencyphysiciantreatingyourchilddoesnotfeeltheyareimprovingwhileintheemergencydepartmenttheycanchosetotreatyourchildfollowingthestudytreatmentsregardlessofwhichmedications(orplacebo)theyhavealreadyreceivedDecisionsregardingwhenyourchildisreadytobedischargedfromtheemergencydepartmentandanyotherinvestigationswillbemadebytheemergencyphysiciantreatingyourchildWhileyourchildisintheemergencydepartment,astudynursewillexamineyourchild’schestpriortoeachtreatmentandthenforanotherminutes(oruntiltheemergencyphysicianstreatingyourchildfeelhesheisreadytogohome)Followingyourreturnhome,astudynursewillcontactyoubytelephonetoseehowyourchildisdoingThestudynursewillcalldailyforthefirstweek,theneveryotherdayforthenextweek,theneverydaysforonemoreweekDuringthisphonecall,theywillreviewwithyouwhatsymptomsofbronchiolitisyourchildhasandtheeffectthisillnessishavingonyourfamilylife(suchashoursofworkmissedandtheneedforvisitstoyourfamilydoctor)ThisphonecallwilltakeaboutminutesofyourtimeIfyourchildisadmittedtohospitalduringtoday’svisittotheemergencyroom,astudynursewillcontactyouinhospitaltoreviewyourchild’ssymptomsIntotal,participationinthisstudyfromtimeofenrollmentuntilfollowupisconcludedwillbedaysYourchildwillalsohaveasampleofmucoustakenfromhishernosebysuctiontodeterminewhichvirushascausedyourchild’sbronchiolitisManychildrenwithbronchiolitiswhocometotheEDhavethissampletakenIfyouchosetoparticipateinthisstudy,thetimeyourchildspendsintheemergencydepartmentwillnotbeincreasedPotentialbenefits:Yourchildmaynotdirectlybenefitfromthisstudy,althoughtheinformationcollectedfromthisstudywillimprovefuturetreatmentofbronchiolitisinchildrenPotentialrisks:TherehavebeennostudiesaddressingthesafetyofdexamethasoneinbronchiolitisspecificallybutthereareseveralstudiesexaminingtheirsafetyinotherchildhooddiseasesIthasbeentestedinlargenumbersofchildrenwithcroup(aninfectionnearthevocalcords)andisknowntobesafeTherearesomeextremelyrareproblemsthatmightberelatedtodexamethasoneTheseincludeasevereformofchickenpox(inchildrenwhohavebeenexposedtochickenpoxbeforegettingthedexamethasone),rarecasesofbleedingfromthestomachorintestinesgrowthproblemsinveryill,verysmallprematurebabies(lessthanlbsandbornaboutmonthsearly)andveryrare(estimatedatnomorethanin,)ofsofteningoftheboneofthehipHowever,alloftheseeventsareveryrare,eveninchildrenwhohaveneededmanydosesofdexamethasoneAlthoughwedonotexpectanyoftheseproblemstooccur,wewillbemonitoringfortheseeventsduringtelephonefollowupandbyreviewingthechildren’smedicalchartsFurthermore,nochildwhoknowntobevulnerabletoanyofthesecomplicationswouldbeacceptedintothestudyWithdrawalfromtheStudy:CanBESTstudyconsentformversion:Sept,PageofYouarefreetowithdrawfromthestudyatanytimeandthiswillnotaffectthecareyourchildreceivesCompensation:Intheeventthatyousufferinjuryasadirectresultforparticipatinginthisstudy,normallegalrulesoncompensationwillapplyBysigningthisconsentformyouareinnowaywaivingyourlegalrightsorreleasingtheinvestigatorandsponsorfromtheirlegalandprofessionalresponsibilitiesStudyresults:Attheconclusionoftheresearchstudy,participantswouldbeprovidedwithasummaryoftheresultsofthestudyDuringthecourseofthestudyshouldtheinvestigatorlearnofanyinformationthatisrelevanttoyourparticipationinthisstudywewillsharethisinformationwithyouYoursignatureonthisformindicatesthatyouunderstandtheinformationregardingthisstudyandagreetoyourchild’sparticipationYoursignaturealsoacknowledgesreceiptofacopyofthisconsentformIftheresultsofthisstudyarepublishedyourchildwillnotbeidentifiedinanywayYourchild’spersonalinformationwillbekeptstrictlyconfidentialexceptasrequiredorpermittedbylawAsrequiredbylaw,HealthCanada,aswellasrepresentativesfromtheResearchEthicsBoard,mayhaveaccesstoyourchild’srecordsasitpertainstothisstudyYoumaycontacttheResearchSubjectInformationLineforinformationregardingsubject’srightsinresearchstudiesathowever,thispersoncannotprovideanymedicalinformationwithregardtothisstudyIfyouhaveanyquestionspleasecontact:CanBESTStudyCoordinator:officetbdpagertbcPrincipalInvestigator:DrSandraWhitehouse,MD,FRCPC,OfficePagerSignatureNameDateParentGuardianSignatureNameDateWitnessSignatureNameDatePrincipalInvestigatorCanBESTstudyconsentformversion:Sept,Pageof

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