1. Annual Spring Meeting April 5, 2017
7:00pm
Welcome
M. Everitt/R. Singh/J. Dreyer
7:10pm
Steering Committee Report
M. Everitt
7:15pm
Pedimacs Report
J. Kirklin
7:20pm
DCC Update
7:30pm
Database Committee Report
M. Richmond
7:40pm
Using Registrations as an Effective Platform for Conducting Clinical Trials
K. Grady
8:15pm
Web Based Data Entry System
D. Koehl
8:30pm
Foundation Update & Financial Roadmap
C. Collum/R. Gajarski
8:40pm
Break
8:55pm
Scientific Committee Report
Dipchand
9:05pm
Scientific Committee Sponsored Workshops
9:10pm
New Study Proposal Design
S. Urschel
9:15pm
Pediatric Heart Candidates Listed as Exceptions: Rising Trend After New Allocation Implemented
R. Davies
9:35pm
MATE Study Update
K. Daly/C. Almond
9:40pm
New Business
10:00pm
Adjourn

2. Thank you to our sponsors:

3. PHTS Purpose (Est. 1993)
The purposes of the group are to establish and maintain an international, prospective, event driven database for heart transplantation, to use the database to encourage and stimulate basic and clinical research in the field of pediatric heart transplantation and to promote new therapeutic strategies..(An additional current focus is QA and QI)

4. UAB DCC Personnel PHTS Personnel Additional Support
James K. Kirklin, MD
DCC Director
Nick Timkovich
Lead Developer (WBDE)
Craig Collum, MPH
Foundation Executive Director
Brandon Sharp
Developer (WBDE)
Susanna Lenderman, MPH
Managing Director
Ramaraju Rudraraju, PhD
Elizabeth Pruitt, MSPH
Analytic Manager
John Pennington
Programmer
David Naftel, PhD
Statistical Consultant
Susan Myers
Brittney Wilk, MS
Development Director
Ryan Cantor, MSPH
Lauren Turner
Program Manager
David Helms, MA
Camesha Grigsby
Project Coordinator
Devin Kohl
Monica Henderson
Grant Studdard
Chase Lenderman
Website Administrator

5. PHTS Continues to Grow 1993 2003 2013 Today Institutions 21 25 46 53
Countries 1 2 3 4
Listings
236
2513
6695
8494
Transplants
140
1736
4816
6163
Abstracts - 26 87
111
Publications 9 57 76

6. 53 participating PHTS hospitals
PHTS Continues to Grow
53 participating PHTS hospitals
50 hospitals represented here tonight
5 non PHTS hospitals, several in process of joining
156 registered meeting attendees

7. PHTS Participating Hospitals
United States (48 hospitals)

8. PHTS International 53 Hospitals
United States
Canada
Brazil
England

9. Data Collection and Submission

10. Data Submission Deadlines
Event Occurrence
Months
Absolute Submission Deadline
1st Quarter
January
February
March
April 30
2nd Quarter
April
May
June
July 31
3rd Quarter
July
August
September
October 31
4th Quarter
October
November
December
January 31

11. Building a Better Dataset
Steps for data entry and checking
Work closely with coordinators to ensure timely and complete data submission
Regularly scheduled data consistency checks
Work with coordinators to correct errors or enter missing forms
Check number of transplants reported to UNOS by institution for US hospitals and with PIs for non-US hospitals

12. Building a Better Dataset
Inclusion Criteria
ALL pediatric patients listed for heart transplantation on or after the date of study entry for an institution are eligible for inclusion in the study.
Re-listed patients can now be enrolled at the new PHTS center as a new patient. (As of 09/01/2015)
Simultaneous organ transplantation (other than combined heart-lung) is no longer an exclusion criterion. (As of 01/01/2010)

13. Building a Better Dataset
Exclusion Criteria
Patients who are 18 years of age or greater at the time of listing. (NOTE: there is no age restriction on patient follow-up once they are enrolled. The age restriction is strictly at time of listing) Patients who are listed for a combined heart-lung transplant.

14. Building a Better Dataset
Inclusion Criteria for Research Datasets
90% compliant with all listing forms
90% compliant with all transplant, donor, and immunosuppression forms
90% compliant with all annual follow-up forms
90% compliant with all event forms
Addressed all data queries
In process of incorporating these compliance scores into the data entry system for real time visualization

15. Quality Assurance Reports
QA Reports containing data through 12/31/2016 will be available
June 2017

16. 2016 Pediatric Transplants
US Hospitals (47)
444
Reported by UNOS for all pediatric heart transplant centers
417
Reported by UNOS for PHTS Centers
94%
Potential percentage of all US pediatric heart
transplants if all PHTS centers report 100% of individual center transplants
396
Reported to PHTS for the calendar year 2016
89%
of US transplants (late data entry, no informed consent)
*some patients may be ineligible

17. 2016 Pediatric Transplants
Non-US Hospitals (5) 9
Canadian 18
European 11
Brazilian 38
Total non US transplants reported to PHTS in 2016 9%
Non US center pediatric transplants

18. International Expansion
Upcoming Booths
ISHLT
April 5-7, 2017
World Congress
July 16-21, 2017 (Barcelona, Spain)
PHTS is working to continue to expand the database globally.

19. DCC Update: Research

20. Abstracts and Presentations
2017 Research Proposals
Abstracts and Presentations
ISHLT 2017 (Abstract Deadline: October 25, 2016)
6 abstracts accepted
4 analyses at UAB
2 limited data set requests
56 unique co-authors (representing 29 hospitals)
AHA 2017 (Abstract Deadline: June 12, 2017)
2 proposals accepted
all analyses at UAB
14 unique co-authors (representing 10 hospitals)
ISHLT 2018 Proposals under review - (Abstract Deadline: October/November 2017)
3 proposals to be accepted
20 unique coauthors (representing 16 hospitals)
372 total members of PHTS (including both investigators and coordinators)

21. PHTS Membership Writing Group Distribution
Publications and Abstracts:
76 Publications: 51 Unique First Authors
177 Total Unique co-authors
111 Abstracts: 78 Unique First Authors
254 Total Unique co-authors

22. Impact of PHTS Research on Heart Transplant Community

23. Research Challenges Submitting few papers at time of meeting
Unintended consequences:
Slow submission leads to risk of data becoming out of date with resultant request for “updated” analyses
Invades time needed for current analyses and abstract development
Promotes a culture of lack of discipline in designing (at the outset) the original study in a way that accurately and completely drives the analytic plan

24. Research Challenges Submitting few papers at time of meeting
Unintended consequences:
Slow submission leads to risk of data becoming out of date with resultant request for “updated” analyses
Invades time needed for current analyses and abstract development
Promotes a culture of lack of discipline in designing (at the outset) the original study in a way that accurately and completely drives the analytic plan
ISHLT 2017: 0/6 submitted at time of ISHLT
Expect 6/6 will be submitted immediately after ISHLT

25. Limited Data Set Requests
Policy and Procedures
Purpose to increase scientific productivity and to make data available to members
De-identified dataset specific to the approved proposal is provided to investigators for one analysis, abstract, and manuscript
Goal of PHTS to provide
High quality research
Research equity to all members in good standing who actively participate in data submission

26. Limited Data Set Requests
Submitted Requests
Announced to membership September 25, 2013
Limited data set sent to requesting center
Analyses performed at requesting center
Fee for request: $5,000
2013 submitted request: 1
2014 submitted request: 4
2015 submitted request: 3
2016 submitted request: 1
2017 submitted request: 0

27. Collaboration with UAB
We remain committed to the purposes and vision of the PHTS.
We see a bright future for this 24 year collaboration.
We are always interested in ideas to improve the clinical relevance and productivity of the PHTS and our collaboration.