CCRC MEMBERSHIP INTRODUCTION CCRC INPERSON MEETING MAY 2018

CCRC MEMBERSHIP INTRODUCTION CCRC IN-PERSON MEETING MAY 2018

CCRC VISION &MISSION To become the leading voice in reporting outcomes in CHD interventions To improve outcomes in CHD by shedding light on ◦ Efficacy ◦ Risk factors ◦ Therapeutic superiority

ABSENCE OF (GOOD) DATA 3% Rule Average MD makes 1, 000 decisions per week Darst et al, 2010

CCRC VALUES Equitable Fair Rotating responsibilities Democratic

Other Multicenter Groups Others CCRC Single investigator/institution champion All CCRC members equal partners Permanent lead status on manuscripts Not linked to a single institution Oversight involves large organizations Authorship intentionally rotates ◦ IMPACT/ACC ◦ PHN/NERI Science delayed due to enormity of structure Available data are in registry format ◦ No short-, mid-, or long-term reporting possible CCRC provides internal oversight ◦ Data audits ◦ Investigator performance assurance With good data, minimal delays in generating good science Data are whatever we want to collect ◦ Prospective, retrospective, registry-based

CCRC ORGANIZATION

PRESIDENT (PETIT) VICE PRESIDENT (GOLDSTEIN) FINANCE CHAIR (GOLDSTEIN) DEVELOPMENT & FUNDING CHAIR (PETIT) SCIENTIFIC CHAIR (GLATZ) BIOSTATISTICS CHAIR (MCCRACKEN) DATABASE AND PROGRAMMING CHAIR EXECUTIVE COMMITTEE NEW STUDIES CHAIR (QURESHI) IMAGING CHAIR (SACHDEVA)

TO DATE CCRC began in 2014 CCRC expanded in 2015 CCRC added 2 centers in 2017 (May) CCRC added 3 centers in 2018 (May)

Founding Members 2017 New Members 2018

CCRC ACHIEVEMENTS As Two-Center collaborative: ◦ Two publications ◦ One manuscript pending (GTN/CJP)

CCRC ACHIEVEMENTS As four-center collaborative: ◦ Two publications ◦ One in-press (PA-IVS Technical factors) ◦ Two papers to be resubmitted anew ◦ (PA-IVS Echo f/u) ◦ (PDA morphology study) ◦ Three papers yet to be written ◦ Carotid approach to ductal stenting ◦ Cost analysis: ductal stenting vs surgical shunt ◦ IPADO: impact of palliation on outcomes

ACHIEVEMENTS : AS SIX-CENTER COLLABORATIVE Two abstracts in Preparation ◦ Pulmonary artery Growth in Single ventricle infants following pda stent vs bt shunt (Meadows/glatz) ◦ To be submitted for presentation to aha 2018 ◦ Somatic growth in infants following pda stent vs bt shunt (Nicholson/goldstein) ◦ To be submitted for presentation to aha 2018

CCRC : A NINE-CENTER COLLABORATIVE Tetralogy of Fallot – Major study to begin in Summer 2018

CCRC : OTHER ACHIEVEMENTS Abstracts: ◦ Aortic Stenosis: 3 abstracts ◦ AHA (oral) ◦ PICS ◦ SEPCS ◦ PA-IVS: 3 abstracts ◦ ACC (oral) ◦ PICS ◦ ASE ◦ PDA Stent vs BT Shunt: 5 abstracts ◦ ◦ AHA (oral, winner best congenital abstract) PICS (oral, winner best abstract) AHA (oral) SCAI

CCRC PROCESSES By-laws Goals and Missions Ancillary Studies New Member Applications New Study Proposals Database Creation Process* Data Audit Process* PI Performance Process* * TO BE ENACTED 2018

25 New CCRC Sites by 2019

ACHIEVEMENTS BEYOND 2018 CCRC as vehicle for prospective studies (clinical trials) CCRC generates tool to define Technical Performance in the catheterization laboratory CCRC to generate multiple registries to tract novel interventions for late outcomes ◦ Pulmonary Vein stenosis ◦ Transcatheter palliation of cyanotic neonates ◦ Requires study coordinators ◦ Rigorous data auditing to ensure quality ◦ Durable Funding mechanism All three elements more challenging with increase in number of CCRC sites.

CCRC WEBSITE

CCRC By-Laws All investigators expected to participate in Monthly conference calls Twice yearly in-person meetings (2 -3 days)

CCRC DATA AND STUDY PARTICIPATION Site PI is responsible for data quality and timely submission For investigators functioning as co-investigator (not 1 st or senior author) ◦ PI responsible for data entry by deadline ◦ PI responsible for data accuracy ◦ For all measurements taken from angiograms etc, PI will make those unless otherwise designated

CCRC INVESTIGATOR PERFORMANCE Should we measure this? How should we report this? Balance (encourage/public shaming) Data Quality Timeliness Engagement

CCRC PERFORMANCE ASSESSMENT Yearly evaluation score Emphasis on deadlines (data submissions, abstracts, manuscript reviews) Data audit outcomes ◦ Quality ◦ Timely rectifying data Participation on conference calls, in-person meetings

PERFORMANCE SCORE (EXAMPLES )

CCRC AUTHORSHIP Title PA-IVS Main Study* PA-IVS Technical Factors PA-IVS Echo Study PDA Stent vs BT Shunt – Main Study* PDA Stent – Impact of Morphology on Outcomes PDA Stent vs BT Shunt – Cost Analysis Carotid Access in PDA Stents vs BT Shunts – PA Growth in SV Pts PDA Stents vs BT Shunts – Somatic Growth IPADO Neonatal Tetralogy – Impact of Palliative Strategy * Published First Author Chris Shiraz Maskatia Andy Athar Bryan Holly Bauser-Heaton Jeff Meadows George Bryan Senior Author Bryan Ritu Sachdeva Athar Chris Andy Bryan Andy

CCRC AUTHORSHIP Authorship is academic currency CCRC should regularly review the authorship table ◦ Fairness ◦ Appropriate distribution of work ◦ Review and discussions led by New Projects Chair Spreading academic credit ◦ Part of our DNA ◦ Bolsters CCRC culture among investigators

PI CONSEQUENCES FROM OTHERGROUPS PHTS – loss of authorship for project or term (e. g. 1 -year) PC 4 – loss of access to de-identified dataset AHA Writing Groups – drop in authorship rank * Role-out of these consequences ideally avoided, and would reflect lack of engagement.

LEADERSHIP FROMWITHIN Expectation is that all CCRC members assume leadership positions which rotate over time Balance expertise with democratic approach Want all members fully engaged and invested CCRC should be professionally and personally fulfilling

PRESIDENT (PETIT) VICE PRESIDENT (GOLDSTEIN) FINANCE CHAIR (GOLDSTEIN) DEVELOPMENT & FUNDING CHAIR (PETIT) SCIENTIFIC CHAIR (GLATZ) BIOSTATISTICS CHAIR (MCCRACKEN) DATABASE AND PROGRAMMING CHAIR EXECUTIVE COMMITTEE NEW STUDIES CHAIR (QURESHI) IMAGING CHAIR (SACHDEVA)

OTHER AREAS OF NEED Data Auditing / Quality Chair Performance / Assurance Chair Others

NEW MEMBER SUCCESS IN CCRC Expectations include - Leadership in organization - Academic leadership (1 st authorship) ◦ Lead authorship assumes set of organizational responsibilities including ◦ Setting deadlines, reviewing datasets ◦ Working with biostats chair re: database, audit reviews, etc - Assistance in philanthropy/development efforts

CCRC OTHER CONCEPTS CCRC Partners – ‘mentorship’ of new members from EC members CCRC community liaisons work with local CCRC PIs to raise awareness

BOTTOM LINE CCRC is unique collaboration (organizationally, academically) Everyone is expected to play critical role in all aspects Membership (sites) will remain limited to maintain focus, productivity