Dashboard Review Second Quarter of FY-2016 Joe Selby, MD, MPH - PowerPoint PPT Presentation

Dashboard Review Second Quarter of FY-2016 Joe Selby, MD, MPH Executive Director Michele Orza, ScD Senior Advisor to the Executive Director 1

On Target Projected/Target Q3 2015 Board of Governors FY-2016 Dashboard Off Target Q4 2015 Q2 (As of 3/31/2016) Needs Attention Q1 2016 Our Goals: Increase Information, Speed Implementation, and Influence Research Q2 2016 Expenditures – Total Budget, Up to $424M Funds Committed to Research, Up to $554M % of Research Projects on Track Inputs Q3 Q4 Q1 Q2 Research Q1 Q2 Q3 Q4 Awards 75 Budgeted Q2 Q3 Q4 Budget Percent Research Q1 Q2 Awards 50 Actual Estimated Q2 Q3 Q4 All Other 2016 Budgeted Budget 25 Q2 Actual Process Actual Q2 Q2 Actual All Other Q1 Actual Actual 0 % of Research Projects Meeting 100% of 0 100 200 300 400 500 600 0 50 100 150 200 250 300 350 in Green Zone Recruitment $ Millions $ Millions (Q2: N=326) (Q2: N=117) Final Progress Reports Submitted Journal Articles PCORnet Phase II Research Projects Underway in PCORnet Q3 Q4 Q1 Q2 25 Expected Actual 70 Target Number of Projects Outputs 60 20 Actual 50 0 5 10 15 20 25 15 40 Q1 Actual Q2 Actual 2016 Target 30 10 Networks Engaged in Research Projects 20 10 5 Target 0 Actual 0 Journal Articles Journal Articles About or Uptake Q3-15 Q4-15 Q1-16 Q2-16 0 10 20 30 Published By Awardees By PCORI Results of Engagement in Research Methodology Standards Uptake Highlight: Specialty Physicians & PCOR Enrolling patients in surgical trials is challenging, so Two clinical specialties, Nephrology and Radiology, 100 20 in a PCORI-funded study of patient activation that are working in their fields to implement PCORI compares surgery to antibiotics to treat pediatric Methodology Standards, drive a useful portfolio, 75 15 Use appendicitis, stakeholders provided suggestions and promote uptake of PCORI research results help improve enrollment and retention rates . They 50 10 made the enrollment script more patient- and Results: Influencing Research family-centered and offered an online option for 25 5 follow-up, which increased Catalyzed by PCORI, the Meharry-Vanderbilt NA enrollment in the trial from Alliance developed pre- and post-doctoral programs 0 0 65% to 95%, and increased Methodology CME/CE Methodology Standards in community engaged research, and began Citations Certificates retention from 58% to 85%. Impact including stakeholders in their grant review process 2

Specialty Physicians Engaging with PCORI to drive a useful portfolio and facilitate uptake of results Radiology The Association of University Radiologists Radiology Research Alliance Task Force reviewed all PCORI-funded radiology projects, and described how the PCORI Methodology Standards apply to medical imaging. The Task Force identified opportunities for future projects in the field, and developed a National Agenda ” for PCOR. As radiologists, we must embrace PCOR or risk missing a key opportunity to demonstrate value and improve the care provided to our patients. Zygmont ME, et al. Opportunities for Patient- Centered Outcomes Research in Radiology . Acad Radiology . Jan 2016; 23:8-17. Nephrology In an interview on becoming Editor in Chief of the American Journal of Kidney Diseases, Harold Feldman, MD, MSCE, Director of the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania, highlighted the major studies related to Nephrology that PCORI is funding, and said the journal will focus on translating findings from PCOR into clinical practice. 3

Goal 3 Results: Influence Research Meharry-Vanderbilt Alliance Consuelo H. Wilkins, MD PCORI is credited with being a catalyst for: • Inclusion of community members and stakeholders in Scientific Review Process for the Vanderbilt Clinical and Translational Science Award Pilot Program Observing PCORI’s review process encouraged them to think more broadly about inclusion of o stakeholders in the scientific review and their ability to contribute to proposal review Developing training curriculum based on PCORI’s Mentor Program o • Post-Doctoral Research Fellow Program in Community Engaged Research 2-year program for training researchers in community engagement o 2 full-time fellows are supported each year by the NIH CTSA o • Community Scholars Program for pre-doctoral students One year immersion experience in community engaged research o ” Includes research partnership and mentoring o $5,000 to support the research project; stipend o The motivation of researchers because of PCORI to community organization funding has been a big stimulus for the work that we do… the availability of PCORI funding and the interest was a catalyst for us to be able to expand our reach. Consuelo Wilkins, MD 4

Results of Engagement in Research: Stakeholder Involvement Led to Improved Enrollment Minneci PC, Nacion KM, Lodwick DL, Cooper JN, Deans KJ. Improving Surgical Research by Involving Stakeholders . JAMA Surgery . Feb 2016. • Awarded 2013, Assessment of Prevention, Diagnosis, and Treatment Options project • Principal Investigator: Katherine Deans, MD, Nationwide Children’s Hospital In this PCORI-funded study of a patient activation tool (part of a larger comparison of surgery vs. antibiotics to treat pediatric appendicitis), stakeholders provided suggestions help improve enrollment and retention rates, including making the enrollment script more patient- and family-centered and offering an online option for follow-up. These changes increased enrollment in the trial from 65% to 95% and increased retention from 58% to 85%. ” ” This is why we have our stakeholder group, These are tangible statistics that show that so that we can incorporate their input into this process of involving the stakeholders can all phases of the study. In this situation, it improve the study. was critical to the success of our project. In the Top 5% of research outputs Dr. Minneci, Co-Investigator Dr. Deans, Principal Investigator scored by Altmetric Nationwide Children's Hospital. "Stakeholder involvement in clinical trial design 5 leads to greater recruitment, retention.” ScienceDaily, 10 February 2016.

Progress of Pragmatic Clinical Studies Distribution of Pragmatic Clinical Studies Project Status by Quarter Green Zone Q2 2016 10 2 Yellow Zone Orange Zone Q1 2016 8 Red Zone 0 5 10 15 20 Number of Projects Table 1. Active Research Project Details Q3-15 Q4-15 Q1-16 Q2-16 Number of Active Research Projects 0 7 10 14 (Contracts Executed, have passed the Start Date) Number of Projects Eligible for First Evaluation - 0 8 12 (Active projects far enough along to be categorized based on progress) Percent of Projects on Track (in the Green Zone) - - 100% 83% Number of Projects with Recruitment Milestones in Quarter - - 0 4 Percent of Projects Meeting 100% of Recruitment Milestones - - - 50% 6

Progress of PCORnet Phase II Research Projects Under Way in PCORnet Q4 Q1 Q2 Q3 Target 2 3 13 6 Q1 Q2 Actual 3 10 0 5 10 15 20 25 FY-2016 Targets by Quarter Q1 Actual Q2 Actual Networks Engaged in Research Projects Q2 Q1 Q3 Q4 Target 17 11 5 0 Q1 Q2 Actual 12 13 0 10 20 30 7

PCORnet Network Collaboration There are currently 8 collaborative Research Demonstration projects taking place in PCORnet involving 25 of 33 networks. Network Collaborations in Research Demonstration Projects 14 12 Key Number of Networks ADAPTABLE Study 10 Obesity Studies 8 PPRN Demonstration Projects 6 4 2 0 Observational Study Randomized Trial Study Design 8

PCORnet Front Door Policy April Internal Launch of PCORnet Front Door 5, 2016 Inquiry Types April (as of April 15, 2016) Front Door Policy Approved 15, • 13 Trials 2016 • 4 Observational Studies • 2 Participating Sites Inquiries Public Opening of PCORnet Front Door Summer 2016 Requester Types (as of April 15, 2016) 8 Academic • • 6 Industry • 2 Non-profit/Foundation • 1 National Association • 1 Federal 1 Research Center • 9

DataMart Totals: Research-Ready PCORnet 71 as of March 31 st 75 as of April 15 th 80 as of May 5 th 83 as of May 19 th Data Characterization Progress 90 6 Approved for Research 80 Data Characterization Review 70 Prep-to-Research Ready Phase 60 Number of DataMarts 50 40 Data Characterization Phase 30 20 10 Diagnostic Query Phase 0 Mar 31 Apr 15 May 5 May 19 Time 10

Discussion Questions for Q2-16: • Do our FY-2016 Dashboard and associated background materials cover the topics that are most important for your review ? • Do you have questions or comments about our progress or performance on any of our Dashboard indicators? Does the in-depth focus this quarter on the progress of PCORnet tell you • what you need to know? 11