E valuating  D evices  U
0K - views

E valuating D evices U

sing . C. l. a. ims and Regis. t. ry Data . (. EDUCATe. ). VISION Meeting. September 10, 2018. Disclosures. FDA U01FD005478-01 . –. (. Sedrakyan. PI). National Institute on Aging U01AG046830-01 .

Download

E valuating D evices U




Download - The PPT/PDF document "E valuating D evices U" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.



Presentation on theme: "E valuating D evices U"— Presentation transcript:

Slide1

Evaluating Devices Using Claims and Registry Data (EDUCATe)

VISION MeetingSeptember 10, 2018

Slide2

Disclosures

FDA U01FD005478-01

(

Sedrakyan

PI)

National Institute on Aging U01AG046830-01

Skinner

PI

NESTcc

Demonstration Project – Goodney (PI)

Slide3

Project 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.

Slide4

Assessing

Reintervention After EVAR

is Difficult

Slide5

Assessing

Reintervention After EVAR

is Difficult

Incomplete follow-up

Slide6

Assessing

Reintervention After EVAR

is Difficult

Incomplete follow-up

Poor patient compliance

Slide7

Assessing

Reintervention After EVAR

is Difficult

Incomplete follow-up

Poor patient compliance

Procedures performed at other centers

Slide8

Prior Work: SVS 2017

Compare the rate of

reintervention

after EVAR between 3 data sources

Slide9

Compare the rate of

reintervention

after EVAR between 3 data sources

VQI

VQI-Medicare

Chart Review

Slide10

Reintervention

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%

Slide11

15,000 EVAR 5,000 Open. 10 Year Follow up (Data 11/16/17)

Slide12

Implications

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.

Slide13

Implications

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.

Slide14

Implications

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.

Slide15

Partner OrganizationsAortic endovascular graft manufacturers Cook Medical, Endologix, Bolton Medical, Gore, MedtronicEstablished registries Society for Vascular Surgery Patient Safety Organization FDAMDEpiNet, NESTccCMS

Slide16

Partner OrganizationsAortic endovascular graft manufacturers Cook Medical, Endologix, Bolton Medical, Gore, MedtronicEstablished registries Society for Vascular Surgery Patient Safety Organization FDAMDEpiNetCMS

Slide17

Partner OrganizationsAortic endovascular graft manufacturers Cook Medical, Endologix, Bolton Medical, Gore, MedtronicEstablished registries Society for Vascular Surgery Patient Safety Organization FDAMDEpiNetCMS

Slide18

Partner OrganizationsAortic endovascular graft manufacturers Cook Medical, Endologix, Bolton Medical, Gore, MedtronicEstablished registries Society for Vascular Surgery Patient Safety Organization FDAMDEpiNetCMS

Slide19

Proposed Cohort: Patients who received EVAR and are captured in VQI, CMS and Pre-market trials

Slide20

Data 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

Slide21

MilestonesCreate 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

Slide22

Operational 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

Slide23

Data 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.

Slide24

Status 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

 ----

-- 

 ---

-- 

Slide25

Communication 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

Slide26

Next 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

Slide27

Questions

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?