PCORI and Other Funding Sources

1. PCORI and Other Funding Sources K Scholars Program * April 2013 Michael Steinman, MD Associate Professor of Medicine, Division of Geriatrics Director of Comparative Effectiveness Research, CTSI

2. Disclosure • No conflicts of interest

3. Outline • What is PCORI? • And what is its relation to CER? • Funding opportunities through PCORI • Other funding opportunities in CER and PCOR

4. PCORI • 2010 health reform created Patient Centered Outcomes Research Institute • CER politically unpalatable (“lead to rationing”) • So…focus on PCOR • Quasi-governmental organization funded by tax on insurers • Protected from annual congressional appropriations • Cannot consider cost in coverage decisions; cannot use QALYs; will not fund cost-effectiveness analyses • Otherwise fairly open mandate to create something new

5. PCORI • Different approach to research • PCOR • Stakeholder engagement • “Community based participatory research for health care systems”

6. Patient-Centered Outcomes • “Given my personal characteristics, conditions and preferences, what should I expect will happen to me?” • “What are my options and what are the potential benefits and harms of those options?” • “What can I do to improve the outcomes that are most important to me?” • “How can clinicians and the care delivery systems they work in help me make the best decisions about my health and healthcare?”

7. Patient-Centered Outcomes • Prognosis; comparative options for diagnosis and treatment; improved communication and decision-making • Outcomes that directly impact patient’s lives and well-being • Functional status; ability to concentrate; care for loved ones; pain; NOT biomarkers • Effect size should be meaningful • Evaluate heterogeneity of treatment effects • Real-world settings

8. Stakeholder Engagement • Central to PCORI’s mission • Stakeholders should be involved in ALL aspects of research • Developing research plan, measures, etc. • Patients, providers, policy-makers, etc. • Stakeholders sit on review panels

9. Guidance • PCORI Methodology Report and Methodology Standards • Explicit guidance on preferred methods http://www.pcori.org/research-we-support/methodology/

10. PCORI Funding Opportunities • PFAs – investigator initiated projects • Targeted announcements • Special programs

11. PCORI Funding Announcements (PFAs) • PCORI Funding Announcements • 3 cycles per year • 3 years, up to $500K per year • ~$350 million in 2013 • Five priority areas

12. First Round of PFAs • 25 proposals funded (out of ~500) • $41 million over 3 years

13. First Round of PFAs • Prevention, Diagnosis, Treatment • Cognitive outcomes of antiepileptic drugs in pediatric epilepsy • Helping patients choose peritoneal dialysis vs. hemodialysis • Healthcare Systems • Hospital discharge planning – impact on medication problems, functional status, re-hospitalization

14. First Round of PFAs • Prevention, Diagnosis, Treatment • Cognitive outcomes of antiepileptic drugs in pediatric epilepsy • Helping patients choose peritoneal dialysis vs. hemodialysis • Healthcare Systems • Hospital discharge planning – impact on medication problems, functional status, re-hospitalization Patient-centered outcomes (Outcomes, heterogeneous effects, real-world)

15. Targeted Announcements • Five target areas • Treatment options for uterine fibroids. • Treatment options for severe asthma in African-Americans and Hispanics/Latinos. • Preventing injuries from falls in the elderly. • Treatment options for back pain. • Obesity treatment options in diverse populations. • Actual funding announcements will be posted by July 2013 (in theory)

16. Special Opportunities • PCORI Challenge • Developing a patient/research “matching” system • $50,000 • Others coming down the pike…

17. Not only PCORI • Alternative funding sources • AHRQ • NIH • VA • Foundations • Can do things that PCORI cannot • Career development • Cost effectiveness • Non-patient centered outcomes

18. AHRQ • Beginning series of FOAs in PCOR • Mentored Career Development in PCOR • Junior Investigator: K01; K08 • UCSF K12 PARTNERS Program • Mid-career or Senior Investigator: K18 • Infrastructure Development Program in PCOR • R24 http://www.ahrq.gov/funding/research/announcements/index.html http://grants.nih.gov/grants/guide/notice-files/NOT-HS-13-003.html http://accelerate.ucsf.edu/training/partners

19. AHRQ • CER is one of seven AHRQ “portfolios” • Intramural and contract-based work in CER • Effective Health Care Program • Evidence-Based Practice Centers • Synthesize evidence for conditions or technologies • CERTs • Research and education drugs and devices • DeCiDE Network • Practical studies on outcomes, CER, safety, appropriateness http://www.ahrq.gov/cpi/portfolios/comparative-effectiveness/index.html

20. NIH • Lots of funding in 2009-10 under ARRA • Now selected RFAs: • Secondary Analyses of Comparative Effectiveness, Health Outcomes and Costs in Persons with Multiple Chronic Conditions (R21; NIA) • Dissemination and Implementation Research • R01; R21; R03 (multiple institutes)

21. VA • Not much specific to CER and PCOR

22. Resources • CER Program • http://accelerate.ucsf.edu/research/cer • Consultation resources • 5 free hours of consultation thru consultation services • Links to high value consultation opportunities • Community Engagement & Health Policy • CELDAC • SF Bay Area Collaborative Research Network • Symposium • Updates and Announcements – listserv • Collaboration around RFAs

23. Questions / Comments ? Mike Steinman Mike.steinman@ucsf.edu http://accelerate.ucsf.edu/research/cer