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Women’s Health Technologies CRN Core: FDA | ONC | NLM | AHRQ | MDEpiNet Project Goals Build a Strategically Coordinated Registry Network (CRN) to improve evaluation of women’s health technologies across multiple care settings • Establish a CRN capable of addressing clinical questions on devices, therapies, and their combinations for the treatment of uterine fibroids, pelvic floor disorders and female sterilization. • Create a harmonized, interoperable platform that will link existing registries to each other and to other major data networks for longitudinal follow-up and assessment of patient care across therapeutic areas. • Develop tools to efficiently extract clinical data from electronic health records (EHR) into the CRN using HL7 FHIR profiles and Structured Data Capture (SDC), and ballot developed standards for further use by the clinical community. • Test the ability of the CRN to address 2-3 priority questions identified by stakeholders. WOMEN’S HEALTH TECHNOLOGIES COORDINATED REGISTRY NETWORK • Data element evaluation • Two-tier infrastructure model for some or all clinical areas: o Quality Improvement Tier to address safety and quality improvement questions across the CRN o Research Tier to address detailed research questions within CRN partners • Evaluation of EHR vendor datasets, identification of candidate fields for harmonization, development of common data elements, development of HL7 FHIR profile for data capture and exchange, and integration of Unique Device Identification (UDI) and device information from GUDID into CRN. • Validate the use case and create implementation guides for the clinical community. Ballot and disseminate developed standards and tools to partners and other stakeholders. Project Partnership Single Purpose Registries Coordinated Registry Network for Women’s Health Technologies • Support assessment of real world combinations of care • Harmonized, interoperable platform to support standardized data capture • Address priority questions from stakeholders • Improve longitudinal evidence generation and reduce cost • Time / Cost-intensive • Challenging to address questions involving multiple therapies • Stand-alone design: Challenges with interoperability due to registry-specific data collection / normalization An nationwide registry designed to collect information from women having treatment for uterine fibroids. • PFDR: a multi-centered prospective cohort of patients undergoing treatment for pelvic organ prolapse (POP) to evaluate the effectiveness, quality of life and safety associated with both surgical therapy (and non-surgical management. • AQUIRE: A national urogynecology-focused registry designed to measure and report healthcare quality and patient outcomes. o Used to expand existing efforts and collect data on Stress urinary incontinence (SUI). Workstreams Timeline Governance and Organization • Core Team consisting of representatives from FDA/CDRH, National Library of Medicine, Office of National Coordinator, The American College of Obstetricians and Gynecologists, The American Urogynecologic Society, and Cornell University. • Clinical area teams (sterilization, uterine-fibroids, and pelvic floor disorder) focused on identification of relevant clinical data elements. • Core Clinical Data Element and Informatics Workgroups focused on harmonization of CRN data elements, development of harmonized and standardized data ontology, FHIR development, and data interoperability. Uterine Fibroids Pelvic Floor Disorders Sterilization BUILDING A REAL-WORLD DATA NETWORK TO ADDRESS CRITICAL QUESTIONS ON MEDICAL TECHNOLOGIES UNIQUE TO WOMEN’S HEALTH Registries COMPARE-UF | PFDR & AQUIRE | Collaborative Registry for Sterilization Therapies Cross-Functional Activities Clinical Working Group | Informatics Working Group | UDI Working Group Women’s Health Technologies CRN Core: FDA | ONC | NLM | AHRQ | MDEpiNet The new Collaborative Registry for Sterilization Therapies is aim to address device safety and effectiveness for sterilization therapies. Collaborative Registry for Sterilization Therapies Robust CRN for women’s health technologies which could be scaled and extended to add new technologies For more information, please contact the FDA Project Director, Dr. Danica Marinac-Dabic ([email protected]), or Cornell University PI, Dr. Art Sedrakyan ([email protected]). The poster was prepared by Division of Epidemiology on behalf of WHT CRN team

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Page 1: WOMEN’S HEALTH TECHNOLOGIES COORDINATED REGISTRY …mdepinet.org/wp-content/uploads/WHT-CRN.pdf · improve evaluation of women’s health technologies across multiple care settings

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

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