sing C l a ims and Regis t ry Data EDUCATe VISION Meeting September 10 2018 Disclosures FDA U01FD00547801 Sedrakyan PI National Institute on Aging U01AG04683001 ID: 794000
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Slide1
Evaluating Devices Using Claims and Registry Data (EDUCATe)
VISION MeetingSeptember 10, 2018
Slide2Disclosures
FDA U01FD005478-01
–
(
Sedrakyan
PI)
National Institute on Aging U01AG046830-01
–
Skinner
PI
NESTcc
Demonstration Project – Goodney (PI)
Slide3Project GoalsTo validate a novel mechanism using registry-linked claims data for long-term follow-up after EVAR validated by industry trialsTo outline the potential regulatory and scientific utility of registry-linked claims data sources for pre and post-market assessment.
Slide4Assessing
Reintervention After EVAR
is Difficult
Slide5Assessing
Reintervention After EVAR
is Difficult
Incomplete follow-up
Slide6Assessing
Reintervention After EVAR
is Difficult
Incomplete follow-up
Poor patient compliance
Slide7Assessing
Reintervention After EVAR
is Difficult
Incomplete follow-up
Poor patient compliance
Procedures performed at other centers
Slide8Prior Work: SVS 2017
Compare the rate of
reintervention
after EVAR between 3 data sources
Slide9Compare the rate of
reintervention
after EVAR between 3 data sources
VQI
VQI-Medicare
Chart Review
Slide10Reintervention
After EVAR
Cumulative
Reintervention
Events
Years
1 year
3%
6%
VQI
6%
2 years
11%
13%
3 years
16%
18%
VQI-Medicare
Chart Review
Sensitivity 92%
Specificity 96%
Slide1115,000 EVAR 5,000 Open. 10 Year Follow up (Data 11/16/17)
Slide12Implications
VQI data linked to Medicare claims closely mirrors the actual clinical event
rate can
be a scalable mechanism for device surveillance.
We wish to test this against an external validated data source –
industry clinical trials and registry datasets.
Slide13Implications
VQI data linked to Medicare claims closely mirrors the actual clinical event
rate can
be a scalable mechanism for device surveillance.
We wish to test this against an external validated data source –
industry clinical trials and registry datasets.
Slide14Implications
VQI data linked to Medicare claims closely mirrors the actual clinical event
rate can
be a scalable mechanism for device surveillance.
We wish to test this against an external validated data source –
industry clinical
trials.
Slide15Partner OrganizationsAortic endovascular graft manufacturers Cook Medical, Endologix, Bolton Medical, Gore, MedtronicEstablished registries Society for Vascular Surgery Patient Safety Organization FDAMDEpiNet, NESTccCMS
Slide16Partner OrganizationsAortic endovascular graft manufacturers Cook Medical, Endologix, Bolton Medical, Gore, MedtronicEstablished registries Society for Vascular Surgery Patient Safety Organization FDAMDEpiNetCMS
Slide17Partner OrganizationsAortic endovascular graft manufacturers Cook Medical, Endologix, Bolton Medical, Gore, MedtronicEstablished registries Society for Vascular Surgery Patient Safety Organization FDAMDEpiNetCMS
Slide18Partner OrganizationsAortic endovascular graft manufacturers Cook Medical, Endologix, Bolton Medical, Gore, MedtronicEstablished registries Society for Vascular Surgery Patient Safety Organization FDAMDEpiNetCMS
Slide19Proposed Cohort: Patients who received EVAR and are captured in VQI, CMS and Pre-market trials
Slide20Data Residence and GovernanceData are contributed into a Coordinating Center at Cornell Weill Medical CenterGoodney/Sedrakyan/Mell/Cronenwett direct use of shared data resourcesData GovernanceEach industry partner retains control of their own data sourcesAggregate, de-identified data products would be primary deliverable
Slide21MilestonesCreate a system to securely send PHI from industry trials to a clearing-house for matching at CornellIndustry partners, Cornell/VQI teamGenerate matched datasets (VQI / Cornell Team)IndustryVQIMedicare claimsEvaluate long-term outcomes (VQI / Cornell Team)
Share results with our governance structure
Slide22Operational Team Members
Executive Committee
Device Surveillance Foundation (Cornell/Dartmouth/VQI team)
Industry Leadership Board
Data oversight
Review of deliverables
Aggregate only
Blinded to data source
Slide23Data Sets and Matching Techniques
VQI data begins in 2002 (New England), expands nationally in 2010.
Matching
Indirect (DOB, gender, date of procedure, zip)
Direct (name, SSN, Gender, DOB)
We will take whatever years you can send.
Slide24Status Report
Partners
Steering Committee Members
Milestones
Preparatory Meetings
Attended
Review of Data (Elements Available/
Sharing Concerns)
Legal Contracts
Data Use Agreement Between Coordinating Center and Industry Partner
Cook
Scott Williams
11.16.16
8.16.17
9.14.17
11.3.17
Examined consent documents – only a subset can share data and no PHI;
zipcode
not available; have study from 2002 which may not be represented in VQI
Agreement signed with SVS PSO, includes grant funding plus in-kind donation for data (total $23,000)
Agreement
Executed
DA
TA
RECEIVED 8/14/18
$20,000 Support
Endologix
Meredith Huetter
Matt Thompson
11.16.16
8.16.17
9.14.17
11.3.17
Endologix
team discussed data elements with VQI team
Still reviewing consents and determining which data can be shared
Reviewing materials
pending
Medtronic
Kristel Wittebols
Tiessa Simoes
11.16.16
Phone discussion of data elements 11.14.17
Reviewing
materials
pending
Gore
Roberta Bloss,
Keely Scamper
11.16.16
8.16.17
Confirmed data sharing ok from legal standpoint
Reviewing materials
pending
Bolton Medical
Lea Doyle
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Slide25Communication Timeline7/2017: Proposal sent to Industry Partners and MDEpiNet
8/2017- 12/2017: 4 Steering Committee Meetings held via WebEx or in person at VEITH1/2018: WCM Legal Team shared draft Data Use Agreements shared with Industry Partners
2/2018 - 9/2018: Approximately 60+ Individual follow-up emails and phone calls
Time
Cook Data Set Received to perform analytics
Slide26Next Steps
Using Data Use Agreement at CMS (Cornell)
Patients Present in Cook Data File
Find Cook Patients in Medicare Claims
Measure Outcomes in Claims
Measure Outcomes in Cook Data
Compare Kappa (agreement) between Cook and Claims algorithm
Slide27Questions
What can we do to expedite legal
review in future projects
Who will have access to what kind of
data
What Steps will
NESTcc
take with RWE like this?