Annual Spring Meeting April 26, 2016 7:00pm Welcome M. Everitt 7:05pm Steering Committee Update 7:15pm DCC Update D. Naftel/ S. Lenderman 7:30pm Web Based Data Entry Update 7:40pm Database Committee Update M. Richmond 7:55pm MATE Project Overview C. Almond 8:00pm Break 8:15pm Pedimacs Report D. Rosenthal 8:25pm Foundation Update R. Gajarski 8:35pm Scientific Committee Update D. Hsu 8:45pm Scientific Committee Sponsored Workshop 9:35pm Limited Data Set Request SOP 9:40pm New Business 10:00pm Adjourn

Web Based Data Entry System Initial Goal Create and implement software for electronic entry of data Expanded Goal Create an electronic system for managing data (entry, quality checks, etc.) for managing participating hospitals and local personnel for communication for document delivery for managing regulatory requirements is FISMA/HIPAA compliant

What does the current system include? WBDE Training Session What does the current system include? Phase I October 1, 2015 Mirror of data collection forms Revisit/revision of all forms Tool for data management Create Administrative System Phase II April 2016 Business rules on all forms and data fields Phase III November 2016 Data download of a hospital’s data Phase IV April 2017 Analytics: survival curves and analyses at local hospital

Web Based Data Entry System

Web Based Data Entry System Version 1.0.0 (Released October 7, 2015) Version 1.0.1 (Released October 26, 2015) Version 1.0.2 (Released November 5, 2015) Version 1.0.3 (Released November 19, 2015) Version 1.0.4 (Released December 31, 2015) Version 1.0.5 (Released March 4, 2016) Version 1.0.6 (Released March 28, 2016) Version 1.0.7 (Coming Soon) Version 2.0.0 (Coming Soon)

Web Based Data Entry System Version 1.0.6 Session Time Remaining: 40:54

Web Based Data Entry System Version 1.0.0 (Released October 7, 2015) Version 1.0.1 (Released October 26, 2015) Version 1.0.2 (Released November 5, 2015) Version 1.0.3 (Released November 19, 2015) Version 1.0.4 (Released December 31, 2015) Version 1.0.5 (Released March 4, 2016) Version 1.0.6 (Released March 28, 2016) Version 1.0.7 (Coming Soon) Version 2.0.0 (Coming Soon)

Web Based Data Entry System: What’s Coming Version 1.0.7

Web Based Data Entry System: What’s Coming Version 1.0.7 Auto generation of Donor and Immunosuppression Forms

Web Based Data Entry System: What’s Coming Version 1.0.0 (Released October 7, 2015) Version 1.0.1 (Released October 26, 2015) Version 1.0.2 (Released November 5, 2015) Version 1.0.3 (Released November 19, 2015) Version 1.0.4 (Released December 31, 2015) Version 1.0.5 (Released March 4, 2016) Version 1.0.6 (Released March 28, 2016) Version 1.0.7 (Coming Soon) Version 1.1.0 (Coming Soon)

Web Based Data Entry System: What’s Coming Version 1.1.0 Auto generation of Post Transplant Annual Follow Up Forms (Form 8) for all patients at the time of the yearly transplant anniversary. Forms will display in this grid on the “Site Dashboard” so as soon as coordinators log in to the system they will see which forms need to be completed for which patient.

Web Based Data Entry System: What’s Coming Version 1.1.0: Filtering Site Dashboard

Web Based Data Entry System: What’s Coming Version 1.1.0: Filtering Site Dashboard Show patients Active Show patients Active Inactive Transplanted Alive Waiting Transferred Removed Dead

Web Based Data Entry System: What’s Coming What does the current system include? Phase I October 1, 2015 Mirror of data collection forms Revisit/revision of all forms Tool for data management Create Administrative System Phase II April 2016 Business rules on all forms and data fields Phase III November 2016 Data download of a hospital’s data Phase IV April 2017 Analytics: survival curves and analyses at local hospital *Phase III and Phase IV will be possible with an expansion of the PHTS mission.

10th Annual Meeting: Friday, March 11th – Products for the Sites Site Products Available Today Available July 1, 2016   Data Quality Report Quality Assurance Report Live Data Download Site Research Datasets (SAS) Customized Cohort Reports Outcome Analytics Patient Information I. Accessing Your Data Examining/Validating your data ü Compliance Rates Electronic copies of your data II. Patient Management Tools Clinical timeline Clinical measures across time III. Patient Selection and Outcomes Quality Assurance Report Cohort (subset) report Benchmarking ü  IV. Quality Initiatives Joint Commission Internal Iniatives V. Using Intermacs for Your Research Within your site Across Intermacs P = presentation, M=manuscript, “In testing” “In Development”

WBDE System The Dream: New Opportunities More timely data submission Better quality data More frequent QA reports Unanticipated Consequences Changing Data Entry Personnel More People Training WBDE Training in PHTS New attention from local IRB

WBDE System The Dream: New Opportunities More timely data submission Better quality data More frequent QA reports Unanticipated Consequences Changing Data Entry Personnel More People Training WBDE Training in PHTS New attention from local IRB

WBDE: Form Submission Before and After Launch Number of Forms Entered vs Number of Centers Entering

Centers with No IRB Approval WBDE Regulatory Centers with No IRB Approval Issues Include: Security of data in web based system Turnover in hospital personal Submission of patient information

WBDE: Form Submission Before and After Launch Total Listings Reported 2014 535 2015 453 Jan 1-Mar 31, 2016 54 (should be about 125) Total Transplants Reported 2014 397 2015 356 Jan 1-Mar 31, 2016 48 (should be about 100)