issue 1.2 winter 2003 contents inside 1 TBI Training 2 Who’s Who 2 Upcoming Meetings 3 Do’s and Don’ts of IRB Submission 3 Nodal News 4 PECARN Update 4 Project Sites 5 New Faces 5 An In-Depth Look at the Hypothermia Study 6 Consort Agreement 7 Spotlights 8 Electronic Data Entry: What it is and why you want it 8 Bronchiolitis FAQ N AME T HIS N EWSLETTER , W IN S KI P ASSES contact info 615 Arapeen Drive Suite 202 Salt Lake City, Utah 84108 Phone: (801) 587-7613 Fax: (801) 581-8686 www.pecarn.org TBI Training We are excited to begin the first federally-funded investigator- initiated research study in PECARN. The PECARN Head Injury Project is called Childhood Head Trauma: A Neuroimaging Decision Rule. It aims to identify high- and low-risk indicators for traumatic brain injury (TBI) in children after head trauma. The ultimate goal is to reduce the number of unnecessary CT scans -and their associated drawbacks - performed on children at very low risk of brain injury. TBI is the leading cause of death and disability in children older than 1, but occurs infrequently in children with minor head trauma. Although CT scanning is considered the “gold standard” for diagnosing TBI, and failure to diagnose the condition increases morbidity and mortality, overuse of CT scanning has serious drawbacks. The most important among them is radiation exposure, which may result in death from cancer, estimated as occurring at the rate of one radiation-induced fatality per 2,000-5,000 pediatric cranial CT scans. Minor blunt head trauma, however, is difficult to study because TBI in these children occur infrequently. Fewer than 10 percent of CT scans performed on children after head trauma reveal TBI. Our goal in this study is to enhance the efficiency of CT use in children with head trauma. We will identify the symptoms and signs of TBI after head trauma that will guide decision-making regarding CT use. This will minimize the exposure of these children to the harmful side effects of CT scans, including ionizing radiation, the transport of children away from the direct observation of the emergency department, pharmacological sedation and additional costs. This study will involve 25,000 children, which would not be possible without PECARN. We plan to enroll patients from May 2004 through April 2006. We look forward to your collaboration! NATHAN KUPPERMANN Chairman of the PECARN SUPPORTED IN FULL BY GRANT U03MC00008, MATERNAL AND CHILD HEALTH BUREAU,HEALTH RESOURCES AND SERVICES ADMINISTRATION,DEPARTMENT OF HEALTH AND HUMAN SERVICES. If your title is chosen, you win ski passes to a fabulous Utah ski resort! Email your submission to [email protected]
Transcript
issue1.2winter2003
contentsinside1 TBITraining
2 Who’sWho
2 UpcomingMeetings
3 Do’sandDon’tsofIRBSubmission
3 NodalNews
4 PECARNUpdate
4 ProjectSites
5 NewFaces
5 AnIn-DepthLookatthe HypothermiaStudy
6 ConsortAgreement
7 Spotlights
8 ElectronicDataEntry: Whatitisandwhyyouwantit
8 BronchiolitisFAQ
NAMETHISNEWSLETTER,WINSKIPASSES
contactinfo 615 Arapeen Drive Suite 202
Salt Lake City, Utah 84108Phone: (801) 587-7613
Fax: (801) 581-8686www.pecarn.org
TBITraining
We are excited to begin thefirst federally-funded investigator-initiatedresearchstudyinPECARN.The PECARN Head Injury Projectis called Childhood HeadTrauma:ANeuroimagingDecision Rule. Itaims to identify high- and low-riskindicatorsfortraumaticbraininjury(TBI)inchildrenafterheadtrauma.The ultimate goal is to reduce thenumber of unnecessary CT scans-and their associated drawbacks -performedon children at very lowriskofbraininjury.TBIis theleadingcauseofdeath
and disability in children olderthan 1, but occurs infrequently inchildren with minor head trauma.AlthoughCTscanningisconsidered
the “gold standard” for diagnosingTBI, and failure to diagnose thecondition increases morbidity andmortality, overuse of CT scanninghas serious drawbacks. The mostimportant among them is radiationexposure,whichmayresultindeathfromcancer,estimatedasoccurringattherateofoneradiation-inducedfatality per 2,000-5,000 pediatriccranialCTscans.Minorbluntheadtrauma,however,isdifficulttostudybecauseTBIinthesechildrenoccurinfrequently.Fewer than 10 percent of CT
scans performed on children afterhead trauma reveal TBI. Our goalin this study is to enhance theefficiency of CT use in childrenwithheadtrauma.Wewill identifythe symptoms and signs of TBIafter head trauma that will guidedecision-making regardingCT use.This will minimize the exposureof these children to the harmfulside effects of CT scans, includingionizing radiation, the transportof children away from the directobservation of the emergencydepartment, pharmacologicalsedationandadditionalcosts.This study will involve 25,000
children, which would not bepossible without PECARN. Weplan to enroll patients from May2004 throughApril2006.We lookforwardtoyourcollaboration!
ACORN•ACORNwouldliketowelcomeanewadditiontoourgrowingfamily.StaceyTownsend, our RA atUtah,deliveredababyboy,Brandon.•WehavethreenewRAs, includ-ingEmilyKimatCHOP,LeslieFu-kushima at UCDMC, and KatarinaZoltanatMCW.•WewouldliketothankRyanRa-decki, Jeannie Laezman, and BenDegner for their contributions andwith them the best in their futureendeavors.•Wearealsohappy toannouncethatwehavereceivedwordthatwewill be awarded theHeadTraumastudybyHRSA/MCHB.
CARN•CARN has added a newHEDA!We are pleased to announce thattheUniversity ofMarylandwill bejoiningPECARNasaCARNHEDA.We welcome Rich Lichenstein totheCARNfamilyasthesitePI. •Dr.DianaAlexanderwhoisthesite PI at Franklin Square HospitalCenterwillbemovingtoJohnsHop-kins todoacardiology fellowship.Shewill continue to participate inCARNandPECARNasamemberof
the Hopkins HEDA. Unfortunately,wewillbelosingFranklinSquareasaHEDAsite.
GREATLAKES•MaryAnnGregor,NodalAdmin-istrator, will defend her doctoraldissertation on January 30, 2004andwillbeassuming thenewroleof a Great Lakes co-investigator.Herresearchstudy,“Short-termfol-low-upforacutepediatric illnessesdischargedfromtheED:impactonsubsequent health care utilizationandcosts”,wasbasedondatacol-lected from the Great Lakes PilotProjectconductedlastwinter.• A search for a new Nodal Ad-ministrator is underway and it isanticipated that he/she will jointheGreatLakesNodeatthestartof2004.Pleaseintroduceyourself toournewNAatthePECARNmeetinginSaltLakeCity.•MattDenenberg,MDofSpectrumHealthistheSitePIfortheBronchi-olitisStudy.Perhapsyoumethimatthebronchiolitis trainingsession inSanFrancisco.WelcomeMatt!
•GreatLakeswillhaveanewNod-alAdministrator beginning January5.JennilynSuhajdaisapharmacistandwillfinishherMastersinClini-calResearchAdministrationinearly2004. She has experience doingclinical research site monitoring,has managed a retail pharmacybusiness, andhas special expertiseand interest in pediatric drugs/medications.• Dr. Johnson will be joiningPECARN in replacement of Dr.Mort Brown beginning January2004. He attended the GLM-SCRN meeting on Dec. 10. Hisfaculty profile can be viewed at:http://www.sph.umich.edu/faculty/valenj.html• Dr. Ehrlich will be joiningPECARNinreplacementofDr.Oli-ver Soldes at the beginning of theyear. Heattended theGLMSCRNmeetingonDec10,aswell.HisCVcanbeviewedat:http://www.um-pediatric-surgery.org/new_070198/new/Faculty_Members/Ehrlich/Ehrlich%20CV.htm•WewouldliketothankDr.MortBrown and Dr. Oliver Soldes fortheir hard work and participationandwish them luck in their futureendeavors.
of view of an IRB member who is abiostatistician (so, maybe somewhereinthemiddlebetweenamedicalanda“citizenrepresentative”).
DO fill in and check every box onthe submission form, and don’t forgettosignanddateeachline thatyouaresupposedto.(Sometimes,notfillinginacheckboxforanitemsuchas“Willdatabe shared outside the Covered Entity”or “Does this study include an IND”mayamplifyareviewer’sconcernaboutsomepartofthestudy.)DOmakesurethatboththeprotocol
summary and the consent form givea simple and clear picture of what isgoingtobehappeningtothesubjectatalltimes,andhowlongtheentirestudywilltake.Similarly,inarandomizedstudy,DO
explain what randomization is on theconsent form (and point out clearly ifthe subject has an unequal chance ofgettingonetreatmentortheother).DON’T cut and paste sections from
a technical “master protocol” into theprotocolsummarywithoutmakingsure
theyareunderstandabletoamoderatelyintelligent,nontechnicalperson.DOjustify thenumberof subjects in
thestudyinsomereasonableway.Thiscan be done statistically with samplesize/power calculations, or in morebasic research settings, using practicaljustifications such as total number ofsubjectsorresourcesavailable.DON’T state something like “we are
enrolling 20 subjects because we’vealways found significant results in thepastwiththismanypeople(ormice).”Ifyourstudyisreturned“Tabled”with
requests for revisions or questions thatseemexcessivelynaïveorunreasonable,pleaseDON’Texpressyour frustration,however justifiable, in your responseletter!If thereviewseems tobewayoffon
thewrong track, abriefdirectmeetingwith the IRB chair or the Board mayquicklysolvethemisunderstanding.
RICHARD HOLUBKOVChief Biostatistician
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Psych (Pediatric PsychiatricEmergencies):ThePWGPilotProject,“Referral Patterns and ResourceUtilization for Pediatric EmergencyDepartment Patients Presentingwith a Psychiatric orMental HealthProblem:ThePECARNPsych/MentalHealthWorkingGroupPilotStudy”isunderway.Datacollectionisexpectedto begin at IRB-approved sites onDecember 10th. A second projectis near completion: a PECARN-widesurveyofPsych/MentalHealthissuesintheED.Resultswillbepresentedto PECARN subcommittees in thecoming months. A survey of EDphysicianperceptionofPsych/MentalHealth training is next in line fordevelopment. The group will beworkingonthatearlyin2004.
Prehospital Working Group: Twostudies are being developed furtherfor PECARN, one on C-Spine injuryand the other on Pediatric Arrest.In addition, the Working Groupwill be developing a HEDA surveylooking at EMS systems that servePECARN. If you would like to bea part of the prehospital workinggroup,[email protected].
DisparitiesStudy:Thepurposeofthisstudyistomeasureracialandethnicdisparities inaccess tomedicalcare(prior toEDarrivalaswellas in theED)inpatientswithadelaysensitivecondition such as appendicitisand asthma. A grant applicationwas submitted to the NIH Oct. 1,2003 with primary assignment toAHRQandsecondaryassignment toNICHD.
fundingisreceived,wewillestablishsubcontracts. Study PIs have beenhaving weekly conference calls andareworkingonfinalizingdataforms,workingonmanualofoperations,andcoordinatingIRBsubmissions.SitePIresponsibility and authorship plandocuments have been circulated,and Site PIs are being recruited.Project coordinators at UC DavisandtheCDMCCwillbehiredforthisstudy.Wearecoordinatingatrainingsession on Feb. 5, 2004,whichwillto coincide with the next PECARNmeetinginUtah.
Effectivenessoforaldexamethasoneinacutebronchiolitis:Amulticenterrandomized trial: We had a highlysuccessful training session for thisstudy at the October PECARNmeeting.TheplanisforJanuary2004implementation. Eighteen PECARNcenterswillparticipateandaPECARNDMSBhasbeencreatedforthisstudy.Weare gettingfinal IRBapproval atall sites. The central pharmacywillbe shipping the studymedication toallsitesinmid-December.Hypothermia:Pleaseseenextpage.
PECARNCoreDataProject(PCDP):This study will give us importantepidemiological informationregarding pediatric emergencydepartment visits in the PECARNnetwork. Data collection is nowcomplete and the data analysis hasbegun. Abstracts were submittedon Dec. 8 for the Spring meetingof the Pediatric Academic Societiesmeeting.
BioterrorismSurveillance:Historicaldata has been sent from Children’sNationalMedicalCentertoChildren’sHospitalofBostonandrealtimedatatransferwill begin soon. AdditionalPECARNsitesaregettingIRBapprovalorareintheearlyplanningphases.
Great Lakes Node Pilot Project:Predictors of Follow-up in AcutelyIllChildren:Thiswasaprospective,observational study conducted in 3EDs. A publication plan has beensubmitted to GWAPs, a manuscripthas been drafted and will besubmitted for publicationduring thefirstquarterof2004.
Use of Lorazepam for PediatricStatusEpilepticus:ADouble-blindedRandomized Diazepam ContolledClinicalTrial: InresponsetoanNIHRFA, Children’s National MedicalCenter(CARN-RNC)submittedagrantapplicationtoconductarandomizedclinical trial of Lorazepam versusDiazepam for the treatment ofpediatricstatusepilepticus.Iffunded,thestudywillbethefirstinPECARNto utilize an FDA exemption frominformedconsent.FivePECARNsitesareparticipating,onesite fromeachnodeanda5thsitetobedetermined.These include, Children’s Hospitalof Philadelphia, Children’s Hospitalof Buffalo, Children’s Hospital ofMichigan (aka Prashant’s hospital),Children’s National Medical CenterandonesiteTBD.Since this is a contract mechanism,theNIHinformedCARNinNovemberthat they were in competitive rangeforthegrantandtheyarecurrentlyinnegotiationswiththem.Asitevisittotheapplicantinstitutioninscheduledinmid-December.The original grant was submitted atapproximately $2.94M. The NIHfunded a data coordinating centerakintotheCDMCCforthisseriesofRFA’sandthereforeaskedustoremovesome costs in the negotiations. Thecurrentbudgetis$2.7M.Thegrantapplicationandassociateddocuments can be found in thesteering committee voting eRoomarchiveathttps://www.nedarcssl.org/eRoom/nddp/SteeringCommitteeVotingeRoom/0_3ea3
newfacesSallyJoZuspanI am excited to be a part of thePECARNnetworkas thenewPro-gram Manager. My educationalbackground includes a master’sdegree in BurnTraumaNursing. Ihaveworked as a pediatric emer-gency nurse, pediatric clinicalspecialist and trauma coordinator
at large children’s hospitals in Ohio and Texas. I alsoservedasalobbyistfortheAmericanCollegeofSurgeonsCommittee on Trauma advocating for trauma systems.My research interests include trauma systems, pediatricemergencycare,andinjuryprevention.MyfamilyandIwerestationedwiththemilitaryforthepastthreeyearsinStuttgart,GermanywherewehadgreatfunandadventuretravelingthroughoutEurope.
ReneEnriquezI’m excited to be part of thePECARNnetworkastheCDMCC’sDataResourceManager.Priortojoining theCDMCC Iwaswork-ing for the University of Utah’sClinicalResearchCenterandwasresponsible for coordinating andimplementing the data manage-
RichLichensteinDr. Richard Lichenstein is joiningPECARN as the site PI for the newestHEDAsite, theUniversityofMaryland.Dr.LichensteinisAssociateProfessorofPediatrics, Director of Pediatric Emer-gencyMedicineandAssociateDirectorof the Combined Pediatrics EmergencyMedicineResidencyProgramattheUni-
versityofMaryland.Thereare91inpatientbedsatUniver-sityHospitalforChildrenaccountingfor4,500admissionsannually, including 1,000 admissions to the PICU/IMC.The Pediatric Emergency Department as of November2002isinastateoftheartfacilitywith17,000encountersperyearandgrowing.Dr.Lichenstein’sresearchinterestsincludepediatrictherapeutics,telemedicine&psychiatricemergencies.
AnIn-DepthLookattheHypothermiaStudyCardiopulmonary arrest (CA) in
childhoodisatragiceventthatveryoftenresultsineitherdeathorpoor quality long-term neurologicoutcome. Recent clinical trials inadult populations have reportedbothimprovedneurologicoutcomeandsurvivalinhighlyselectpatientsreceivingshort-termmildhypother-mia(32-34°C)followingoutofhos-pital arrests. The efficacy of mildhypothermia in children followingcardiacarrest in themodernera is
notknown.Inuncontrolledreportstwodecadesago,moderatehypothermia(30-32°C)incontrasttomild(32-34°C)hypother-miawasassociatedwithtrendstowardsworseoutcomes.Inthisclinical trialplanninggrantapplication,15children’shospitalswith large intensive care unitswill obtain pilot data, from themedical recordsofpatientswhohavesustainedaCA ineither
the outpatient or inpatient setting. Characterization of thispopulationwill include arrest specificdetails, etiology, patientcharacteristics,hospitalcourse, interventions received,hospitalsurvival, and neurologic outcome. Approximately 500-1000patients are anticipated tomeet study criteria and their chartswill be retrospectively reviewed over the 12-month period ofthispilotstudy.Thedata fromthisstudywillbeused tocreateinclusionandexclusioncriteria,tocalculatesamplesizerequire-ments,andpreparedocumentsneeded fora futurerandomizedcontrolledtrial(RCT)ofhypothermiafollowingpediatriccardiacarrest.Durationoftimetosuccessfullyenrollpatientsfromthiscohortof15children’shospitalsforafutureRCTwillbeestimat-ed.ThePECARNsupportofthisstudywithitsexistingclinicaltrialsresearchinfrastructurethatincludesasteeringcommittee,fiveclinicaltrialssupportingsubcommittees,andacentraldatamanagement coordinating center (CDMCC).The CDMCCwillmakeoperationalalldataandanalysisrelatedtasksofthisappli-cation,andassureallstudysitesarecompliantwithregulationsconcerningdatasecurityandconfidentiality.
FRANK MOLERPrincipal Investigator
mentportionsofNIHandmulti-centerclinicalresearchstudies. While at the CRC I initiated the developmentofCRIS (Clinical Research Integrated System), a systemthatstreamlinesthedevelopmentandimplementationofresearch databases. I graduated from theUniversity ofArizonawithaBSinManagementInformationSystems.I’mcurrentlyfinishingaMSinMedicalInformaticsattheUniversityofUtah.Myresearchinterestsarefocusedondatamanagementofresearchdata,metadatareuse,andresearch system frameworks. I am married, have twodaughters, ranging inage from9weeks to3years. Apersonalgoalofmineistosomedaylearnhowtoflyandobtainmypilot’slicense.
web
sites
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ConsortAgreementThose of you involved in the
bronchiolitis study planning may havebeenexposedtosomethingcalled“theCONSORT statement”. CONSORT,which stands for CONsolidatedStandards Of Reporting Trials, is achecklist of 22 items that need tobe reported when the results of arandomized trial are submitted forpublication. So, CONSORT can bethoughtofasaroadmapforwhatneedstobekepttrackofwhenatrialisbeingdesignedandcarriedout.It’s not completely surprising that
two different clinical trials comparingthe same treatments can give differingresults; this can certainly happen bychance alone. But certainly, onestudy can be “stronger” than anotherin different ways. A double-blindstudy is less likely to have bias thanan open-label study. Results from astudy where 90% of eligible patientswere randomized may be less biased,and more generalizable, then findingsfrom a study where 75% of eligiblesrefused to participate, and similarly along-term study is stronger if subjectretentionduringfollow-upishigh.Iftheproportionofrandomizedsubjectswhodon’t receive the assigned treatmentis large, an intention-to-treat analysiscan be misleading. And so on. TheCONSORT checklist (you can find thearticle,effectivelyinthepublicdomain,at http://www.consort-statement.org/revisedstatement.htmlistscharacteristicsof the trial that thegrowingnumberofhealth care and biomedical journalsthat have adopted CONSORT will belooking for in the write-up. Havingthis information will allow physiciansas well as more statistical types suchas meta-analysts with information toevaluatethequality,rigor,andpotentialgeneralizabilityoftheresultsofagiventrial, on its own and in comparison toothersimilarstudies.In the planning of the bronchiolitis
study, we have been particularlyconcerned about what is expected interms of documenting patient flow.The CONSORT patient flow diagram,reproducedbelow, indicates that some
sort of accounting system is expectedstarting with all subjects who areassessed for eligibility as potential trialsubjects. Any assessed or approachedpotential subject who drops out atany point in the trial process has tobe accounted for with a reason fordroppingout!Categories of dropping out can
include: patient not eligible, eligiblebutrefusingconsent,consentingbutnottreated,treatedbutdroppingoutduringfollow-up,or completing the studybutnot included in the final publishedanalysis.Reasonsfordroppingoutcanbemanyandvaried.Goodstudyplanninginvolvesmeeting
the letter of the CONSORT statementwithoutexcessivelyburdeningthestudyin terms of resources needed to trackexclusions and dropouts. The careful
reviewofpatientflow,andother studydetails,neededtoconformtoCONSORTcan make a proposed trial strongerand more efficient in many aspects(in addition to keeping statistical-typepeoplehappyandemployed).
RICHARD HOLUBKOVChief Biostatistician
winter2003 page7
spotlightsStaceyTownsend,RA(ACORN)
Hello everybody. I am theBronchiolitis Study Coordinator/Lead RA at Primary Children’sMedicalCenterinSaltLakeCity,Utah. Igraduatedfrommedicalschoolhere last springand tookthe year off before starting aresidencyinpediatricstohaveababy.Myson,Brandon,iseightweeksoldnowandisthejoyofmylife.Ialsohaveawonderfulhusbandof five years, Scott. Inour spare time, we enjoy water
skiing, camping, hiking, and now more than ever,sleeping.Ihopetogettoknowallofyoubetteroverthenextyear.
TasmeenSingh,NodalAdmin.(CARN)PECARN would call mea BIRCLA (Born in India,RaisedinCanada,LivinginAmerica)eh. Inaddition toworking as a CARN nodaladministrator, Iamalso theEMSC coordinator for DCand manage the Centerfor Prehospital Pediatricsat CNMC. I go to schoolpart-time working towardsa Doctor of Public Healthdegree in Health Policy. Iam also a paramedic andteach PALS and PEPP andhave an MPH in epidemi-ology. If you think I should
AmyDrongowski,RA(GreatLakes)I have recently completedmy Master’s in MedicalSociology at EasternMichigan University. I wasborninAnnArborandhaveworked at the University ofMichiganforthepast11yearsinPediatricSurgery/PediatricTrauma - certainly feels likehalf of my lifetime! Mygraduate thesis, “Consumerslackbasic knowledge abouttheirchild’shealthinsurancecoverage”, was based ondatacollectedinthePediatricSurgeryclinic.IjoinedtheGreatLakesNodeinmid-September,2003.
SteveMiller,NodalPI(PED-NET)A native NewYorker, Steve didhis undergraduatework at ColumbiaUniversityinEnglish,and later completedmedical schoolat CU’s Collegeof Physicians and
Surgeons. He completed his Pediatrics residency atMontefioreMedicalCenter,andwaschiefresidentatBronxLebanonHospitalCenter/AlbertEinsteinCollegeofMedicine.Stevelaterservedasco-CoordinatorofResidentEducation,aswellasDirectorofEducationand Pediatric Emergency Service at Bronx LebanonHospital.
In1993,Stevecame toColumbiaUniversityBabiesand Children’s Hospital-New York PresbyterianHospitalwhereheservedasthefoundingDirectorofPediatricEmergencyMedicine.Today,ithasninePEMboard-certified attending physicians, an accreditedfellowship program and a new 8000 foot state ofthearthome, featuringa level I2-bay traumaarea,16examinationbays,areverseisolationroomandachild-friendlywaitingarea.
SteveisalsotheDirectorofMedicalStudentEducationin Pediatrics, and the Arnold P. Gold AssociateProfessorofClinicalPediatrics.Dr.Miller’sacademicworkhasbeenintheareaofmedicaleducation.Hehasdisseminatedhisworkthroughaseriesofinvitedprofessorships and national workshops, and he haspublishedintheareaofhumanisminmedicine.
Steve is married to Dr. Dodi Meyer, a native ofArgentinaandAssistantClinicalProfessorofPediatricsandDirectoroftheDysonInitiativeattheChildren’sHospital ofNewYork-Presbyterian.They have threebilingual children Jesse (as in Jesse James) age 11,Mayaage10andNicoage6.Steveplaysguitarandhas a famous relative in the entertainment industry.Steve has a burning desire to play Hamlet at theDelacorteTheatreinCentralPark.
page8 winter2003
Bronchiolitis:FrequentlyAskedQuestions
What classifies “Mild” disease as anexclusioncriteria?
Ifthepatient’ssymptomsare“mild,”bydefinition they are not eligible for thestudy.Mildmeanstheyhavebeengivenan RDAI (Respiratory Distress Assess-mentInstrument)scoreoflessthan6byastudy-trainedclinicianandtheyhave“adequate”oxygensaturation,andthepatient is breathing comfortably. Sitesattypicalaltitudeswilldefineadequatesaturationsforthisstudyasgreaterthan92%.Ifthepatientmeetsallthecriteriafor“Mild”diseaseatthetimeofinitialevaluation by the participating clini-cian, then check the appropriate boxanddiscontinuescreening.Thepatientisnoteligibletocontinuethestudy.Besure to finish filling out the screeninglog.
Whatdowedo if apatienthasbeenrandomized,buthasnot received themedication yet and deteriorates (i.e.isintubatedortransferredtotheICU,or leaves the hospital for any otherreason)?
All randomized patients need to be
analyzed for statistical purposes. Thiswillbeuncommon,butinthiseventweshould recordallavailabledata,espe-ciallythatwhichwouldallowpossiblefollow-up.
Whathappens if a patient vomits thedrugaftersometimeperiod,forexam-ple1hour?Dowecontinuetoobservethepatient?Whataboutfollow-up?
Ifthepatientvomitswithin20minutes,this should be recorded on the dataformC2,#4. No furtherdrugwillbeadministered,however,becauseasyouwillrecall,thevialwasrandomizedandwedonotknowifthepatientreceiveddrugorplacebo. If thepatientvomitsafter20minutes, it isnotevenneces-sarytorecordit.Inanycase,observa-tionandfollow-upshouldcontinueasitwouldotherwise.
Howclose in timedo theRDAI,vitalsignsandoxygensaturationneedtobedone?
All measurements for all three studyexamsshouldbedonewithin20min-utes of each other. When the nurse/technicianisrecordingtheexaminationinformation,remindthemtodoitwhile
thepatientisawake,upright,andcalm.If your site routinely performs nasalsuctioning, theexaminationshouldbeperformedafterthepatienthasreceivedsuctioning and is given time to calmdown.
Howlongdoesapatientneedtobeoffoxygen for their oxygen saturation tobeconsideredaroomairsaturation?
Thepatientshouldbeoffoxygenforatleastoneminutefortheoxygensatura-tiontobeconsideredaroomairsatura-tion. If,however, thepatient’soxygensaturationfallstolessthan80%inlessthan a minute, it is not necessary towaitthefullminutebeforeputtingthemback on oxygen. In this case, docu-menttheoxygensaturationas79%andallowthenursetoputtheoxygenbackonthechild.
How soon after the patient has beendischargeddoIneedtoenterthedatafromtheCRFtotheweb?
Thedataentrytothewebsiteshouldbecompleted within 3-5 days of the EDvisit. In addition, the Follow-up CRFshouldbeenteredontothewebwithin3-5daysofitscompletion.
TheElectronicWebEntryproject,drivenby the Hypothermia and Bronchiolitisstudies,isverycool.Studysiteswillbe
abletosubmittheirpatientstudydatatotheCDMCCusingaWebbrowsertofilloutaformonoursecurewebsite.Thereare no obtuse VPN clients to install,firewall ports to open, etc. All patientdata is automatically encrypted usingSSL, the same technology that protectsyourcreditcardnumberwhenyoubuysomethingonline.ItallstartswithyoupointingyourwebbrowsertoourWebEntrywebsite.Oncethere,you’llloginusingyourWebEntryusernameandpassword.You’llbepre-sentedwithalistofalltheformsinthestudy.Clickonthenameoftheformyouwant to complete. Now enter all yourdataintotheformandclickthesubmitbutton.Hereiswhereitgetsgood.Whenyouclicksubmit,theWebEntrysystem
scanstheentireformforproblemssuchas invaliddates (February30th), impos-siblevalues(atempof130degrees)andmissingdata(forgotthepatientnumber.)Ifthereareanyproblemswiththedata,anerrormessage isdisplayed,explain-ing exactly what’s wrong and how tofixit.Onceallthedatalooksgood,itisrecordedintheCDMCCdatabase.Thishelps ensure the data is accurate andcompletebeforeitgetstothedatabase.In summary, the ElectronicWeb Entryprojectwillmakeiteasierformoresitesto provide cleaner and more accuratedata.Withthisframeworkinplace,theCDMCCwill be able to support moreconcurrentstudieswhileensuringaveryhigh level of data quality.This, I thinkyou’llagree,isverycool.
