spared...

PublicHealthContext

Step 1: Assemble the FDA HIFU RegistryWorking Group in 2016

Step 2: Extract major data “elements” from CRFsand other known sources of data (both pre- andpost-market)…rename to “SPARED” in 2017

Step 3: Harmonize critical data set with existing sets of data acquired from other validated sources

Step 4: Combine both data sets into one central hub of data elements. Create definitions for eachdata element, or use an already-approveddefinition by the American College of Surgeons (ACS).

Step 5: Invite stakeholders from around the country to convene and discuss the formation ofthe HIFU (now called “SPARED” CRN - 2017)..

Step 6: Core Data Minimum will be distributed once consensus is reached àto be adopted across the U.S. to build the Coordinated Registry Network

1. PRO’s not consistently OR completely reported across approved devices.

2. GUDID, PROs, EHR, UDI information needs to be cross-linked with existing data set to reduce burden

3. Partnerships and Sustainability committees must be selected and roles assigned

4. Informatics team needs to be assembled5. Establish structured reporting system to hold

all parties and committees accountable6. Come to consensus on the existing core set.7. Develop methodology so that all ablation

devices are equally a part of the coordinated registry network

We need YOU:• Become a part of the next generation of

SPARED• We are actively recruiting volunteers to co-

chair informatics, sustainability, and prioritization teams

• Transform the next generation of medical device epidemiology into reality

• For more information, please contact Dr. Helen Jiang at Hongying.Jiang@FDA.HHS.GOV

Results

HowcanIgetinvolved?

Methods

CurrentGaps

References&PastEvents

SPARED – The Study of Prostate Ablation Related Energy DevicesA Coordinated Registry Network (CRN) For Prostate Ablation Devices

• Thousands of pages of CRF’s were analyzed and pertinent data elements were extracted

• The SPARED core data elements list is complete, but needs further input from industry, academia, and other key stakeholders to finalize core data elements

• A score / ranking system was established• Preliminary core data set is in motion à need to

further harmonize with both internal and external input.

• Delphi Consensus manuscript written: Consortium of nationally representative medical device registries

• Buy-in from representatives present at this year’s meeting was reached 9/25/17

http://mdepinet.org/event/spared-workshop/

http://mdepinet.org/

• Over 3 million men are living with prostate cancer in the United States.

• In 2017 prostate cancer introduced 161,360 new cases into the U.S.

• 27,730 men living in the U.S. will die this year from prostate cancer

• Rapid adoption of novel technologies for prostate ablation necessitated need to monitor safety and efficacy in the post market space.

• More companies with novel technologies are applying for clearance/approval (2 devices are currently approved for use)

• The MDEpiNet Center at Weill Cornell has initiated this study in a multi-disciplinary effort

• Think-Tank meeting was held on July 22, 2016 and spared the formation of a distributed registry system to meet growing needs

AblationRegistryDataElementsA 10/6/2017

BradleyHunt,HelenJiang,TonyDu-OSB/DEPI(YellowindicatesthedataelementappearsacrossallAblationdeviceCRFs)

DataElements CodeEDAP

AblathermSonacareSonablate

DeviceA DeviceB DeviceC

ScreeningVisitSubjectID# x x x x xVisitDate x x x x xInvestigatorSignature x x x x xInformedConsent x x x x xInclusionCriteria(achecklist) x x x x xGleasonScore(of7orless(combinedscore)) x x x x xExclusionCriteria(achecklist) x x x x xDemographics(DOB,Race/ethnicity) x x x x xASAClassification-seebelow: x x x x x

Class1-HealthyPatient,nomedicalproblems x x x x xClass2-Mild,systemicdisease x x x x xClass3-Severesystemicdisease x x x x x

Class4-Severesystemicdiseasethatisaconstantthreattolife x x x x xClass5-Morbid,notexpectedtolive24hoursirrespectiveofoperation x X x x x

UrinaryTractInfection(UTI)?Y/N x x x x naInterestinfuturefertility? na x x x naBaselinePhysicalExam x x x x xBaselineLaboratoryEvaluations x x x x xSerumLab(PSA,testosterone) x x x x xUrineLaboratoryResults x x x x xOverallAssessment na na na x x

MedicalHistory&PhysicalExamVitalSigns(height,weight,pulse,respiration,bloodpressure) x x x x xECOGPerformanceStatus na na na x partialFindingsonDRE(palpableprostate?Consistency,regularity,etc.) x x x x xProstateDimensions na x na x naHistoryofUrethralStent x x na na naUrologicalHistory x x x x xChestpain/Respiratory x x x x xCardiovascular/Cardiacproblems x x x x xEars,Eyes,Nose,Throat(EENT) x x x x xAllergy x x na? x xGI x x x x xGenitourinary/Urogenital x x x x xEndocrine(Diabetes) x x x x naMusculoskeletal/Rheum. x x x x xNeurological/Psychological x x x x xMetabolic x na x x xPulmonary/Respiratory x x x x xHead&Neck x x x x na