1. Agenda 7:30pm Welcome M. Everitt/R. Chinnock/J. Alejos 7:40pm
Steering Committee Update
Melanie Everitt
7:45pm
DCC Update
James Kirklin
8:00pm
Database Committee Report
Marc Richmond
8:15pm
Foundation Update
Craig Collum
8:30pm
DISCUSSION
Research Project Timeline of Submission
Progression of Elections
8:55pm
Pedimacs Update
Betsy Blume
9:10pm
Scientific Committee Report
Anne Dipchand
9:20pm
New Officers and New Business
9:30pm
Adjourn

2. Thank you to our sponsors:

3. 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
DeAnna Beckham
Registry Support
Ryan Cantor, MSPH
Chase Lenderman
Website Administrator
Devin Kohl
Brittney Wilk, MS
Development Director
Bob Kasco
Information Security/IT
The PHTS research efforts have a large group at UAB to draw upon for database and research analytics expertise, many of whom are available for this effort because of a majority of their funding from other sources. As PHTS continues to grow, the staff continues to grow to manage the activities of the database.

4. 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.
So, this is the mission statement for PHTS, established in Note how closely it mirrors our current activities.

5. 1993 2003 2013 Today Institutions 21 25 46 54 Countries 1 2 3 4
PHTS Continues to Grow
1993
2003
2013
Today
Institutions 21 25 46 54
Countries 1 2 3 4
Listings
236
2513
6695
8380
Transplants
140
1736
4816
6376
Abstracts - 26 87
113
Publications* 9 57 83
*210 Unique co-authors since 1993

6. Data Collection and Submission

7. Building a Better Dataset
Steps for rigorous 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
During this time when we are working to finalize these data sets we regularly communicate with the coordinators for anything inconsistencies in the data and any missing forms to make sure the data is as complete and as accurate as possible for the research projects and the QA reports. Each spring, we also compare the number of listings and transplants reported from US hospitals with the number reported to UNOS to ensure that all eligible patients have been entered into the database. For non-US hospitals, we confirm the listing and transplant counts with the local PI.

8. 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)
Patients eligible to be included in the database are all patients under the age of 18 at time of listing for transplant. Starting in September 2015 when we launched the web based data entry system, we also revised the inclusion criteria to include all patients being listed for a retransplant who had a previous transplant at another institution or at the same institution before that center joined PHTS. Previously these patients were not eligible. This is important because it allows us to capture a group of listings and transplants that prior to September 2015 we were not capturing.

9. 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.
As a reminder, the patients that are not eligible for PHTS are those over 18 at time of listing and those being listed for a heart-lung transplant. Heart-lung are the only simultaneous organ transplants that are not eligible.

10. Building a Better Dataset
Inclusion Criteria for Research Datasets: 90% Rules
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
For a center to be included in the research data sets, they must be at least 90% compliant with all listing, transplant, event, and follow-up forms. They also must have addressed all data inconsistency checks. For questions about compliance scores, please contact Susanna. We are in the process of incorporating these compliance scores into the web based data entry system so that coordinators and PIs can see in real time what their compliance score is at any time.

11. Data Submission Deadlines
Event Occurrence
Months
Absolute Submission Deadline
1st Quarter
January
February
March
April 30
2nd Quarter
April
May
June
July 31
(2017 deadline extended to October 31)
First bi-annual Quality Assurance (QA) reports to be distributed in December 2017.

12. Quality Assurance Reports
Reports will contain data on events through June 30, 2017.

13. Quality Assurance Reports
ALL 53 active centers will be included in reports for the first time in 5 years!
*PHTS current has 54 participating centers. 53 active centers and 1 inactive center.

14. 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

15. Quality Assurance Reports
Reports including events through December 31, 2017 will be available
July 2018

16. Quality Assurance
Should PHTS Be a Quality Assurance Registry, which could avoid missing patients?
Current Practices
23 centers (43%) have a waiver of informed consent
31 centers (57%) require informed consent
2016 Listings
40 (6%) patients declined consent in 2016
583 Listings entered
Reasons for No Consent:
Declined Consent
Language Barrier
Died before consent
Too sick to consent

17. Web Based Data Entry System
Recent Releases

18. Version 1.1.2 (Released August 9, 2017)
Compliance Reporting
Users can see in real time their missing and completed follow-up forms in relation to their compliance score for follow-ups for all time, the previous year, and the current year.
Users can download their annual follow-up reports which details all follow-ups submitted for their site.
Users can see in real time their follow-up percentage to help meet quarterly deadlines and ensure site stays above 90% compliance as we approach the form submission deadlines.

19. Version 1.1.3 (Released September 29, 2017)
Sticky Notes
Sticky notes are now used for all data integrity checks.
Sites can see all data integrity checks on their dashboard all in one place with their form submission (previously all done through )
Streamlines data inquiries being sent back to the sites.
Users can view reports of sticky notes sent to determine common issues with data submission.
More efficient data cleaning allows for better quality data.
Sites can add their own sticky notes to send to colleagues if they have questions about how a particular form should be completed.

20. Web Based Data Entry System
Upcoming Releases
1.1.4 Release (Will Be Available December 2017)
Clinical trial tracking
Revised infection definition
Infection organism mapping
Upcoming Releases
Annual follow-up medication mapping (previously free-text)*
Listing and transplant reconciliation added to wbde system,
Additional range checks and in-form validations (including lab values and hemodynamics)
Enhanced patient summary
Past due form rules
Data Download (presented at April meeting)
Analytics (presented at April meeting)
Clinical Summary Report (presented at April meeting)

21. Web Based Data Entry System
Upcoming Releases
1.1.4 Release (Will Be Available December 2017)
Clinical trial tracking
Revised infection definition
Infection organism mapping
Upcoming Releases
Annual follow-up medication mapping (previously free-text)*
Listing and transplant reconciliation added to wbde system,
Additional range checks and in-form validations (including lab values and hemodynamics)
Enhanced patient summary
Past due form rules
Data Download (presented at April meeting)
Analytics (presented at April meeting)
Clinical Summary Report (presented at April meeting)

22. WBDE: Analytic Software Package
Data Download
The Form Download is a tool that allows sites to download all data they have entered into the Web-Based Data Entry System.
The Form Download is broken down by each individual form. The Form Download follows the Web-Based Data Entry Screen
Allow sites to download any data they enter into the Web-Based Data Entry by form in Excel format
Allow sites to see an instantaneous update from data entered in the Web-Based Data Entry to each downloaded form

23. Excel Charts from the Form Download (Intermacs)
Implant Year (2015) by Device Type
Implant Year (2016) by Device Type
Row Labels
Count of Internal Form Status
Incomplete
456
Validated
1174
Grand Total
1630

24. WBDE: Analytic Software Package
Clinical Summary Report
Provide coordinators with an easy to read summary on all clinical characteristics for a single patient
Key information in the PHTS Web-Based Data Entry condensed into a few summary pages
Contains charts and other helpful features to see changes in lab vales over time

25. Clinical Summary – De-identifed Example (Intermacs)

26. WBDE: Analytic Software Package
Cohort Comparison
The Cohort Comparison tool entails the creation and delivery of reports that describe the user-defined cohorts. After the user has selected the criteria for the cohort, they may select “cohort report” and print a PDF report of their selection
The user-defined cohorts may be compared:
A single cohort selection from a site
Between the site’s own patients based on subgroups (cohort # 1 and cohort # 2)
Between the site’s own patients (cohort # 1) and an equivalent overall PHTS (cohort # 2)

27. Example: Competing Outcomes (Intermacs)

28. Example: Subgroups Within Site - Kaplan-Meier (Intermacs)

29. Web Based Data Entry System
Analytic Software Package (available in Jan. 2019)
Data Download
Clinical Summary Report
Cohort Comparison
Outcome Analytics