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Collaborative Retrospective Study on retinal OCT in Neuromyelitis Optica Handbook for electronic OCT and clinical data transfer Version 1.1 from October 13, 2016 Dear fellow NMOSD-researchers, Thank you for your interest in CROCTINO! This handbook will guide you on how to upload OCT data (Spectralis or Cirrus) for the CROCTINO project. It is necessary that only anonymous data are transferred to the CROCTINO Study Team. As such, you are required to label all data (in spreadsheets and filenames) with an individual CROCTINO ID for each patient. The processes of assigning the CROCTINO ID, exporting and preparing your OCT data, as well as transferring OCT and clinical data are described in this manual. When your center decides to participate in the CROCTINO project, please contact the CROCTINO study team, so that we can assign you a unique center ID, create access to the data upload tool, and send you all necessary information to get started. Please, do not hesitate to contact the CROCTINO study team in case there are any questions concerning the project: CROCTINO Study Team Phone: +49 30 450 539 797 E-Mail: [email protected] Note for participation The CROCTINO project (PI Friedemann Paul, Charité – Universitätsmedizin Berlin, Germany) will investigate OCT changes in NMOSD in a large multicenter study supported by the Guthy- Jackson Charitable Foundation. The authorship policy for CROCTINO advances under the aegis of GJCF-ICC. Specifically, while the active participants, e.g. dataset contributors, will have the option to be included the byline authorship, all ICC members will have the opportunity to prospectively review and provide input to any manuscripts, and agree or decline to be recognized as part of the byline or affiliated authorship as their contributions warrant. After CROCTINO is finished, all OCT datasets will be available through the NMO imaging repository NOIR. All collaborators can gain access by request to the Guthy-Jackson Charitable Foundation. All data uploaded needs to be anonymized and are not allowed to contain any personal information. By uploading data you confirm that this is the case and that you have the rights to upload the data.
Transcript of electronic OCT and clinical data transfer
Collaborative Retrospective Study on retinal OCT in Neuromyelitis Optica
HandbookforelectronicOCTandclinicaldatatransferVersion1.1fromOctober13,2016
DearfellowNMOSD-researchers,
ThankyouforyourinterestinCROCTINO!
ThishandbookwillguideyouonhowtouploadOCTdata(SpectralisorCirrus)fortheCROCTINOproject.
ItisnecessarythatonlyanonymousdataaretransferredtotheCROCTINOStudyTeam.Assuch,youarerequiredtolabelalldata(inspreadsheetsandfilenames)withanindividualCROCTINOIDforeachpatient.TheprocessesofassigningtheCROCTINOID,exportingandpreparingyourOCTdata,aswellastransferringOCTandclinicaldataaredescribedinthismanual.
WhenyourcenterdecidestoparticipateintheCROCTINOproject,pleasecontacttheCROCTINOstudyteam,sothatwecanassignyouauniquecenterID,createaccesstothedatauploadtool,andsendyouallnecessaryinformationtogetstarted.
Please,donothesitatetocontacttheCROCTINOstudyteamincasethereareanyquestionsconcerningtheproject:
CROCTINOStudyTeam
Phone:+4930450539797
E-Mail:[email protected]
Noteforparticipation
TheCROCTINOproject(PIFriedemannPaul,Charité–UniversitätsmedizinBerlin,Germany)willinvestigateOCTchangesinNMOSDinalargemulticenterstudysupportedbytheGuthy-JacksonCharitableFoundation.
TheauthorshippolicyforCROCTINOadvancesundertheaegisofGJCF-ICC.Specifically,whiletheactiveparticipants,e.g.datasetcontributors,willhavetheoptiontobeincludedthebylineauthorship,allICCmemberswillhavetheopportunitytoprospectivelyreviewandprovideinputtoanymanuscripts,andagreeordeclinetoberecognizedaspartofthebylineoraffiliatedauthorshipastheircontributionswarrant.
AfterCROCTINOisfinished,allOCTdatasetswillbeavailablethroughtheNMOimagingrepositoryNOIR.AllcollaboratorscangainaccessbyrequesttotheGuthy-JacksonCharitableFoundation.Alldatauploadedneedstobeanonymizedandarenotallowedtocontainanypersonalinformation.Byuploadingdatayouconfirmthatthisisthecaseandthatyouhavetherightstouploadthedata.
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Contents Page Handbook for electronic OCT and clinical data transfer 11 Assigning the CROCTINO ID 32 OCT data preparation 4
2.1 Data from Spectralis OCT 42.1.1 RNFL Ringscan 42.1.2 Macular Volume Scan 52.1.3 Export of Spectralis OCT scans as E2E file 6
2.2 Data from Cirrus OCT 82.2.1 Optic disc scan 82.2.2 Macular volume scan 82.2.3 Export of Cirrus OCT Scans as ZIP files 8
3 eCRF/Data upload 103.1 Tutorial 103.2 REDCap flowchart 11
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1 AssigningtheCROCTINOIDItisnecessarythatonlyanonymouspatientdataaretransferredtous.Assuch,youarere-quiredtolabelalldata(inspreadsheetsandfilenames)withanindividualCROCTINOIDforeachpatient.ThisIDconsistsofacodeforyourcenter(e.g.BERforBerlin),anunderscore,andconsecutivefour-digitnumbersforeverypatient:BER_0001,BER_0002,BER_0003,…
Ifyoudon’tknowyourcenter’sID,pleasecontacttheCROCTINOstudyteam.
Werecommendstoringade-identifyinglistfortheCROCTINOIDsofpatientsfromyourcen-ter,asexemplifiedinthetablebelow.
CROCTINO-ID InternalID SubjectName Dateofbirth Group
BER_0001 ID04444 Doe,John 13/06/1971 NMOSD
BER_0002 ID06666 Roe,Jane 16/01/1987 NMOSD
BER_0003 ID09999 Simpson,Lisa 04/01/1954 NMOSD
BER_0004 ID02222 Skywalker,Luke 31/07/1955 NMOSD
BER_0007 ID09898 Brown,Charlie 24/05/1979 Control
BER_0008 ID04545 Müller,Thomas 09/10/1986 Control
BER_0009 ID03232 Mustermann,Erika 02/09/1980 Control
WearegoingtosendyouanExceltemplateandanIDassignmentsheetforyourconven-ience.
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2 OCTdatapreparationWeencourageallCROCTINOparticipantstosubmityouroriginalCirrusscansasDICOMfilesandSpectralisscansasE2Efilestoensurethatallscansundergothesamequalitycontrolandparametersarecalculatedandevaluatedinthesamesoftwareversions.Forthis,weofferyoutheonlinedataserviceofourreadingcenter.Hereyoucancomfortablyuploadyourfilesasdescribedinthefollowingparagraphs.
2.1 DatafromSpectralisOCTInCROCTINOwewillanalyzeparametersfromtwodifferentscanprotocols:
1) ThestandardRNFLringscanaroundtheopticdisc(RNFL-N)forperipapiilaryretinalnervefiberlayer(RNFL)globalandquadrantthicknessmeasures.WeusenewerSpectralisversions,however,yourcentermighthaveusedacombinedprotocolofaradialscanandthreeringscans(ONH-RC)insteadofaringscan.ThisisacceptedbyCROCTINOaswell.
2) Amacularvolumescan.Fromthisscan,wearegoingtoperformsegmentationtoevaluatethetotalmacularvolume(TMV)andintra-retinallayerthicknessesfromthecombinedganglioncellandinnerplexiformlayer(GCIP)andtheinnernuclearlayer(INL).
2.1.1 RNFLRingscan
2.1.1.1 RNFL-NThescanprotocolfortheRNFLringscanispre-setonallcurrentHeidelbergEngineeringEyeExplorer(HeyEx)versionsasRNFL-N.Settingsare:
- Highresolutionmode
- Scanangle:12°
- ART:upto100frames(Thisisthenumberofimagesaveragedperrecord)
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2.1.1.2 Alternatively:ONH-RCTheOpticnervehead–RadialCircle(ONH-RC)isusedinnewerSpectralisversionsandisanautomaticallypositionedRadialScanautomaticallyfollowedbythreeringscansofdifferentdiameter.Ifyourcenterhasperformedthisscan,pleaseuploaditinsteadoradditionallytotheRNFL-Nringscan.
2.1.2 MacularVolumeScanThereiscurrentlynostandardforthemacularvolumescanprotocolforHeidelbergSpectralis.Assuch,weacceptdifferentscanprotocols.HoweverwecanonlyacceptscanswhicharesufficientinsizetoincludetheETDRSringfortheTMV,whichhasa6mmdiameter.Thatmeans,yourscanfieldsizeshouldhaveatleast20°x20°andbecenteredonthefoveacentralis.Inthisarea,thereshouldbeatleast25cross-sections(B-scans).PleasecontacttheCROCTINOstudyteamifyouarenotsurewhetheryourscansfulfillthecriteria.
Examplesforacceptablescanprotocols:
- Spectralisstandardprotocol“FastMacula”(25verticalB-scans,Highspeedmode,scanningangle=20°×20°,ART=9)
- Spectralisstandardprotocol“Macula”(25verticalB-scans,Highresolutionmode,scanningangle=20°×20°,ART=49)
- SpectralisstandardprotocolPPole”(61horizontal(tilted)B-scans,Highspeedmode,scanningangle=30°×25°,ART=15)
- Spectralisstandardprotocol“PPoleN”(61verticalB-scans,Highspeedmode,scanningangle=30°×25°,ART=15)
- Customprotocols,e.g.fromSchneiderE.etal.,PloSOne2013:(61B-scans,Highspeedmode,scanningangle=30°×25°,ART=13)
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2.1.3 ExportofSpectralisOCTscansasE2EfileFororganizeddatasharing,werecommendthefollowingprocedurefortheexportofyourOCTimages:
• CreateadirectoryontheSpectraliscomputerwhereyouintendtosavethescans,forexampleC:\Desktop\CROCTINO-Export.ThencreateafolderforthepatientwhosedatayouareintendingtoexportandnameitwiththeirCROCTINOIDconsistingofyourthree-charactercenterIDandafour-digitconsecutivenumber,forexampleBER_0001.
• ThedatayouselectedforCROCTINOmustbeexportedasafile(Format:E2E).Forthis,dragtheselectedscansintothelightboxandmarkthem.
• CROCTINOisopenforlongitudinaldata.Ifavailable,youcandragimagesfromseveralsessionsintothelightbox.
• Thenright-clickononeofthescansandselect“Export->asE2E”.
• The“ExportOptions”menuwillopeninanewwindow.
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• Destination:Browseyourdirectorycreatedbeforeforthespecificvisityouwanttoexport.
• Replacethefields“Lastname”,“Firstname”and“PatientID”withtheCROCTINOIDofyoursubject.
• Click“OK”andwaituntiltheexportisfinished.• RepeattheprocedureforeverypatientorhealthycontroleligiblefortheCROCTINO
project.
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2.2 DatafromCirrusOCTInCROCTINO,wearegoingtoanalyzeparametersfromtwodifferentCirrusscanprotocols:
1) Anopticdiscscanforretinalnervefiberlayer(RNFL)measures2) Amacularvolumescan(preferablyMacularCube512x128,alternativelyMacularCube
200x200)forthetotalmacularvolumeandintra-retinallayermeasurements.
2.2.1 OpticdiscscanThescanprotocol“OpticDiscCube200x200”ispre-setoneverycurrentCirrussoftwareandisavolumescanof200horizontallinescans,eachconsistingof200A-scans.Itfocusestheopticdisccenter.Thedeviceautomaticallycalculatestheperi-papillaryRNFL(averageandquadrants)ina3.4diameterringaroundtheopticdisc.
2.2.2 MacularvolumescanCirrusprovidestwoscanningprotocolsformacularvolumescans,“MacularCube512x128”and“MacularCube200x200”,withdifferentresolutionindifferentdimensions,respective-ly.Wepreferthe“MacularCube512x128”.However,ifyouhaveonlyused“MacularCube200x200”withyourpatients,pleasesendthedataanyway,sincetheprotocolswerefoundtobecomparable.Ifyouusedbothscans,pleasesendusboth.
2.2.3 ExportofCirrusOCTScansasZIPfilesFororganizeddatasharing,werecommendthefollowingprocedurefortheexportofyourOCTimages:
• CreateadirectoryontheCirruscomputerwhereyouintendtosavethescans,forexampleC:\Desktop\CROCTINO-Export.ThencreateafolderforthepatientwhosedatayouareintendingtoexportandnameitwiththeirCROCTINOIDconsistingofyourthree-charactercenterIDandafour-digitconsecutivenumber,forexampleBER_0001.ThisstepiscrucialherebecauseCirrusanonymizedexportdoesnotbacktracktheanonymizedfiles!
• StarttheCirrusSoftware• ThedatayouselectedforCROCTINOmustbeexportedasZIPfiles.Forthis,click
Records->Exportexams
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• Path:Browsethedirectorycreatedbefore.• Makesurethebox“Exporttozipformat”isticked.• Tickthebox“Omitpatientidentifiers”->“Omitpatientname”.• SearchforthenameorIDofthesubjectwhoseimagesyouwanttoexport.• Selectthevisitandtheexaminationsthatyouwishtoexport(pleaseonlyonevisitat
atime).Selectonemacularcubeandoneopticdiscscanforeacheye.Ifyouhaveseveralscansandarenotsureaboutthequality,selectallofthem.Markthefourscansbyusingctrl+(left)click.
• CROCTINOisopenforlongitudinaldata.Ifavailable,youcanmarkimagesfromseveralsessionsasdescribedabove.
• Click“Export”andwaituntiltheexportisfinished.• RepeattheprocedureforeverypatientorhealthycontroleligiblefortheCROCTINO
project.
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3 eCRF/DatauploadTheexportedOCTfilesmustbetransferredtotheCROCTINOStudyteamviaInternet.IfyourOCTmachineisnotconnectedtotheinternet,thedatacanbetransferredtoaporta-blestoragemedia(e.g.USBflashdisc)andfromtheretoPCwithinternetconnection.
Aweb-basedplatform(REDCap)forsharingdemographic,clinicalandOCTdataofthesub-jectsisprovided.Withacurrentlyavailablebrowser(InternetExplorer,Firefox,Chrome,Opera,etc.)pleaseaccessthefollowingwebsitefordataupload:
https://redcap.utahdcc.org/redcap/
HaveyourCenter-IDready(senttoyoubyEmail),aswellastheCROCTINO-PatientIDsforyourpatients(Center-ID,underscore,followedbyfourconsecutivenumbers,e.g.BER_0001).
ToaccesstheCROCTINOREDCapproject,youarerequiredtogetanaccountfromtheDataCoordinationCenter(DCC)oftheUniversityofUtah.Ifyoudonothaveanaccountyet,pleasefindtheformintheappendixandsenditfilledtocroctino@neurodial.de.Wewillthencreateanaccountforyourcenterassoonaspossible.
Afterloggingin,selecttheCROCTINOproject.Addanewsubjectrecordbyselecting“Add/EditRecords”fromtheleftsidemenu.Thenselectthecorrectarmyoursubjectbelongsto:ForNMOSDpatients,select“Arm1:NMOSDpatients”,forhealthycontrols,select“Arm2:HealthyControls”.Followtheinstructionsgivenintheflowchartbeloworvideotutorial.Pleasenotethatrecordscanbesavedatanypointandrevisedatadifferenttimepoint.Leaverecordstatus(“Complete?”)on“Incomplete”ifyouplantocontinuelater,andsetrecordon“Unverified”onceyouaredonefillingitout.
3.1 TutorialWehavepreparedavideotutorialforusingtheREDCapdatabase.Thistutorialisavailableviaourwebsiteat:http://www.neurodial.de/nmosd
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3.2 REDCapflowchart
Thankyouagainforparticipation!
CROCTINOStudyTeam
Phone:+4930450539797
E-Mail:[email protected]
Web:http://www.neurodial.de/NMOSD
