Women’s Health Technologies CRNCore: FDA | ONC | NLM | AHRQ | MDEpiNet
Project GoalsBuildaStrategicallyCoordinatedRegistryNetwork(CRN)toimproveevaluationofwomen’shealthtechnologiesacrossmultiplecaresettings
• EstablishaCRNcapableofaddressingclinicalquestionsondevices,therapies,andtheircombinationsforthetreatmentofuterinefibroids,pelvicfloordisordersandfemalesterilization.
• Createaharmonized,interoperableplatformthatwilllinkexistingregistriestoeachotherandtoothermajordatanetworksforlongitudinalfollow-upandassessmentofpatientcareacrosstherapeuticareas.
• Developtoolstoefficientlyextractclinicaldatafromelectronichealthrecords(EHR)intotheCRNusingHL7FHIRprofilesandStructuredDataCapture(SDC),andballotdevelopedstandardsforfurtherusebytheclinicalcommunity.
• TesttheabilityoftheCRNtoaddress2-3priorityquestionsidentifiedbystakeholders.
WOMEN’S HEALTH TECHNOLOGIES COORDINATED REGISTRY NETWORK
• Dataelementevaluation
• Two-tierinfrastructuremodelforsomeorallclinicalareas:o QualityImprovementTiertoaddresssafetyandquality
improvementquestionsacrosstheCRNo ResearchTiertoaddressdetailedresearchquestionswithinCRN
partners
• EvaluationofEHRvendordatasets,identificationofcandidatefieldsforharmonization,developmentofcommondataelements,developmentofHL7FHIRprofilefordatacaptureandexchange,andintegrationofUniqueDeviceIdentification(UDI)anddeviceinformationfromGUDIDintoCRN.
• Validatetheusecaseandcreateimplementationguidesfortheclinicalcommunity.Ballotanddisseminatedevelopedstandardsandtoolstopartnersandotherstakeholders.
Project Partnership
SinglePurposeRegistries
CoordinatedRegistryNetworkforWomen’sHealth
Technologies• Supportassessmentofrealworldcombinationsofcare
• Harmonized,interoperableplatformtosupportstandardizeddatacapture
• Addresspriorityquestionsfromstakeholders
• Improvelongitudinalevidencegenerationandreducecost
• Time/Cost-intensive
• Challengingtoaddressquestionsinvolvingmultipletherapies
• Stand-alonedesign:Challengeswithinteroperabilityduetoregistry-specificdatacollection/normalization
Annationwideregistrydesignedtocollectinformationfromwomenhavingtreatmentforuterinefibroids.
• PFDR:amulti-centeredprospectivecohortofpatientsundergoingtreatmentforpelvicorganprolapse(POP)toevaluatetheeffectiveness,qualityoflifeandsafetyassociatedwithbothsurgicaltherapy(andnon-surgicalmanagement.
• AQUIRE:Anationalurogynecology-focusedregistrydesignedtomeasureandreporthealthcarequalityandpatientoutcomes.
o UsedtoexpandexistingeffortsandcollectdataonStressurinaryincontinence(SUI).
Workstreams
Timeline
Governance and Organization• CoreTeamconsistingofrepresentativesfromFDA/CDRH,
NationalLibraryofMedicine,OfficeofNationalCoordinator,TheAmericanCollegeofObstetriciansandGynecologists,TheAmericanUrogynecologic Society,andCornellUniversity.
• Clinicalareateams(sterilization,uterine-fibroids,andpelvicfloordisorder)focusedonidentificationofrelevantclinicaldataelements.
• CoreClinicalDataElementandInformaticsWorkgroupsfocusedonharmonizationofCRNdataelements,developmentofharmonizedandstandardizeddataontology,FHIRdevelopment,anddatainteroperability.
UterineFibroids
PelvicFloorDisorders
Sterilization
BUILDING A REAL-WORLD DATA NETWORK TO ADDRESS CRITICAL QUESTIONS ON MEDICAL TECHNOLOGIES UNIQUE TO WOMEN’S HEALTH
RegistriesCOMPARE-UF | PFDR & AQUIRE | Collaborative Registry for Sterilization Therapies
Cross-Functional ActivitiesClinical Working Group | Informatics Working Group | UDI Working Group
Women’s Health Technologies CRNCore: FDA | ONC | NLM | AHRQ | MDEpiNet
ThenewCollaborativeRegistryforSterilizationTherapiesisaimtoaddressdevicesafetyandeffectivenessforsterilizationtherapies.
CollaborativeRegistryforSterilizationTherapies
RobustCRNforwomen’shealthtechnologieswhichcouldbescaledandextendedtoaddnewtechnologies
Formoreinformation,pleasecontacttheFDAProjectDirector,Dr.DanicaMarinac-Dabic([email protected]),orCornellUniversityPI,Dr.ArtSedrakyan([email protected]). TheposterwaspreparedbyDivisionofEpidemiologyonbehalfofWHTCRNteam
