1. How did I find PCORI? Why Did I Apply To Be A Stakeholder Reviewer? What Did I Do In Training? How Did The Stakeholder Review Process Go?

2. HOW I FOUND PCORI 3. I FOUND PCORI IN MY TACOS. 4. TACOS (TABLE OF CONTENTS SERVICE)* (served up by the medical library) Choose up to 10 Medical Journals. Get Tables of Contents - Delivered to the Door. Select 2 Articles from Each Journals TACO. Get Copies of those Articles - Delivered to the Door. STILL A GREAT WAY TO KEEP CURRENT! *Thanks, Dick Kammer, wherever you are. 5. IN ONE OF THE PCORI ARTICLES JAMA, 4/18/12 ---VOL. 307, NO. 15; PP. 1583-4. DRS. SELBY AND BEAL WROTE The underlying imperative is to improve patients care experience, decision making, and health outcomes. Patients as well as the physicians and other health care professionals who care for and about them are invited and encouraged to join this effort. I went to the PCORI website and read more 6. WHY I APPLIED TO BE A STAKEHOLDER REVIEWER 7. If PCORI wanted people to help direct research toward what mattered to patients, I wanted to help. So, I applied, was interviewed, and was selected. Then, the work as a Stakeholder Reviewer began. 8. STAKEHOLDER TRAINING AND REVIEW PROCESS 9. 10/15/12 TRAINING SESSION #1 Overview of PCORIs Mission, Background and Priorities. Description of Merit Review Roles, Process, and Criteria. Guide to PCORI Online and the Scoring Process. Walkthrough of a Sample Application. Discussion of the Integrity of the Review Process. Then, on to reviewing PCORIs Applications 10. PCORI ONLINE Each reviewer was assigned to one of 4 groups. I had 6 applications to review, grade, and critique. During that time, there was a Town Meeting/Webinar for questions, answers, comments, and discussion. There was a deadline for submitting the grading and critiques of the assigned applications. 11. PCORI ONLINE (CONTINUED) Then we all reviewed all the applications assigned to our group before we arrived in D.C. for Training Session #2 and the Merit Review. 12. 11/14/12 TRAINING SESSION #2 In Preparation For The Merit Review, we participated in a Mock Review. We learned, evaluated, and discussed in teams. Each Stakeholder Reviewer played a role in the Mock Review. 13. 11/15/12 PCORI MERIT REVIEW 2 Research Reviewers, 1 Stakeholder Reviewer, and 1 Patient Reviewer presented each application. Then there was discussion about each application. Then all Reviewers graded each application. On 12/18/12, PCORI announced the Funding Awards from the 11/15/12 PCORI Merit Review! 14. SUMMARY OF MY EXPERIENCE A Great Group of talented PCORIANS Led, Guided, Trained, And Prepared Us For The Merit Review. A Great Mix Of Scientists, Patients, And Stakeholders. All Reviewers Treated Each Other As Valuable Colleagues. The Chairs Moderated The Discussion So That Different Points Of View Could Be Heard. The Panel Was Run Smoothly, Efficiently, On Schedule. 15. Hope youll join us on our journey! Thank you. JBMD03092113 16. How PCORI Picks Topics to Study Chad Boult, MD, MPH, MBA Director, PCORIs Improving Healthcare Systems program March 9, 2013 17. 2 What is PCORI Looking For? PCORI wants to support rigorous research: that produces trusted information that will improve health care and outcomes that patients and their families care about. 18. 3 What Do Patients Care About? Good health Relief from symptoms Good health-related quality of life Function (ability to do what they want to do) Safety from medical harm Survival 19. 4 How Should PCORI Select Promising Research Topics to Support? 20. 5 1. Cast a Wide Net Questions submitted through PCORIs portal http://www.pcori.org/get-involved/suggest-a- patient-centered-research-question-survey Questions posed at PCORI-sponsored workshops. Questions identified by IOM, NIH, AHRQ, and other organizations and associations Questions submitted by PCORI staff members 21. 6 2. Initial Screening To remove questions: About cost-effectiveness About the causes of disease That do not measure patient-centered outcomes That do not compare approaches to improving patient-centered outcomes That have already been answered, or are in the process of being answered. 22. 7 3. Select Questions That Best Meet Four Criteria The question addresses a problem that puts a large burden on society, or on a subset of it. The question focuses on patient-centered outcomes (PCO). Answers to the question are likely to improve healthcare practices and PCO. Answers to the question could be obtained within a few years. 23. 8 4. Advisory Panels Prioritize the Top Questions Advisory panels (12-21 people) include patients, stakeholders, and researchers. Panelists receive a background topic brief on each of about 12 questions to be prioritized. Panelists meet in-person, using discussion and software, to prioritize the 12 questions for the PCORI Board of Governors (BoG). Panel meetings are webcast for all to hear. 24. 9 Criteria for Prioritizing Questions 1. The burden that the problem puts on society 2. The patient-centeredness of the question 3. The need for new information about benefits and harms to choose between alternative interventions 4. The likelihood that answers to the question would be implemented in practice 5. The durability of the answers to the questions. 25. 10 Targeted Funding Announcements Following the BoGs approval, PCORI staff members write and release solicitations for applications for contracts to conduct research to answer the highest-priority questions. Merit review of submitted applications 26. 11 First Two Rounds 1. The first set of such targeted funding announcements (3-5 questions) will be released this May. 2. The second set (12-15 questions) will be released later this summer. 27. 12 Getting Involved Patients, stakeholders and researchers can participate in this selection process. Submit questions to:http://www.pcori.org/get- involved/suggest-a-patient-centered-research- question-survey. Apply to be a member of an Advisory Panel:http://www.pcori.org/advisory-panel- application-center. Apply to be a member of a merit review panel: http://www.pcori.org/get-involved/reviewers. 28. Patient/Advocate/Activist Regina Greer-Smith MPH FACHE Coordinator Chicago/Partners Patient Engagement Cluster - CPPEC March 5, 2013 29. Why Am I Here? Because of a series of family medical events.* A former health system administrator, healthcare director and decision-support analyst, she is now a health coordinator for over 500 developmentally and intellectually disabled adult patients. I have been given the opportunity to share my story and experiences to engage and assist patients/ families/and stakeholders in decision-making for a better quality of life with their healthcare. 2 Regina Greer-Smith * At the request of the presenter, this information was amended on March 28, 2013 to protect her familys privacy. 30. Regina Greer-Smith Patient/Advocate/Activist Active with PCORI since July 2012 Data Workshop in Palo Alto July 2012 Member of PCORI Working Group for October Patient Workshop- Planning Participant in the Workshop Oct 27-29, 2012 As a result of the October Workshop, a group of workshop participants (including me and Pastor Bruce) created: The Chicago/Partners Patient Engagement Cluster CPPEC 3 31. The Chicago/Partners Patient Engagement Cluster (CPPEC) is a team of community advocates with diverse backgrounds in the health sciences and community advocacy who are converging to address issues of health disparities and health inequities in underserved, minority and communities with elevated risk. Our goal is to partner with PCORI to engage diverse and populations with elevated risk with researchers. Establish a community engaged working group that fosters engagement of diverse populations in clinical and translational research. 4 The Chicago/Partners Patient Engagement Cluster (CPPEC) 32. Collaborate with the folks next to you Get to know them; whats going on, what do you see, whats needed? What are you looking for from research? What Questions do you have? Where/who are the researchers? Do they know you? Get Together LET US HELP YOU CREATE YOUR PATIENT ENGAGEMENT CLUSTER Email: Regina @ healthcareresearch@sbcglobal.net 5 You can form your own patient/family/Stakeholder Cluster, starting now: 33. Get Involved: Join Us On Our Journey Susan Hildebrandt, MA Director, Stakeholder Engagement March 9, 2013 1 34. Suggest a Research Question www.pcori.org/questions P2 We want to know what health care question you may be facing Your input can help us refine our research agenda 35. Become a Reviewer of Funding Applications PCORI invites professional and lay audiences to be reviewers of research applications Help us support research that will be both scientifically rigorous and truly patient-centered Learn more and apply online: www.pcori.org/get-involved/reviewers/ 3 36. Targeted Funding Work Groups Preventing Injuries from Falls in the Elderly March 12, 2013 Treatment Options for Back Pain March 21, 2013 Obesity Treatment Options in Diverse Populations April 16, 2013 P4 37. Connect with PCORI www.pcori.org 5 38. Introducing PCORI Joe Selby, MD, MPH Executive Director, PCORI Wichita, Kansas March 9, 2013 1 39. Introducing PCORI PCORI is a new non-governmental, not-for-profit research institute that funds research intended to provides patients and those who care for them the information they need to make better informed health care decisions. Our core duties are to: Establish national research priorities Establish and carry out a research agenda Develop and update methodological standards Disseminate research findings 2 40. What PCORI Means by Engagement December 12, 2012 3 41. PCORIs Board of Governors P4 PCORI Board of Governors, March 2012 in Baltimore, MD 42. Source: Affordable Care Act. Subtitle DPatient-Centered Outcomes Research. PUBLIC LAW 111148MAR. 23, 2010. The purpose of the Institute is to assist patients, clinicians, purchasers, and policy- makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis that considers variations in patient subpopulations and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of medical treatments, services. Purpose Of PCORI What is PCORI from The Affordable Care Act 43. Why PCORI? BMJ ClinicalEvidence 2013 44. PCORI Funding Approximate 2012 2013 2014 2015 .... 2019 $150,000,000* $300,000,000 $500,000,000 $500,000,000 $500,000,000 * 20% each year goes to AHRQ/HHS 7 45. Some of PCORIs Key Accomplishments Defined Patient-Centered Outcomes Research (PCOR) Established National Priorities and First Research Agenda Awarded 50 Pilot Projects Approved Revised Methodology Standards Awarded 25 Primary Research Projects Built a Robust Patient and Stakeholder Engagement Program 4 46. What is Patient-Centered Outcomes Research? Patient-Centered Outcomes Research (PCOR) helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options. 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? 9 47. What Does PCORI Mean By Patient- Centeredness? Does the proposed research compare the effects of treatment options that matter to patients; are these realistic choices faced by patients or other decision-makers? Does the research focus on outcomes of interest to patients and their caregivers, such as health, health-related quality of life, functioning, symptoms, safety from medical harm, survival and satisfaction with care? 48. National Priorities for Research and Research Agenda Assessment of Prevention, Diagnosis, and Treatment Options Improving Healthcare Systems Communication & Dissemination Research Addressing Disparities Accelerating PCOR and Methodological Research 49. Our Research Portfolio: 50 Pilot Projects Advance the field of patient-centered outcomes research Support the identification of methodologies Identify gaps where methodological research needs further development Approved April 25, 2012 50 projects 24 states $31 million 12 50. What Did We Fund in Cycle I? 9 6 6 4 Assessment of Prevention, Diagnosis, and Treatment Options Improving Health Systems Communications and Dissemination Research Addressing Disparities Average Award: $1,698,072 Average Award: $1,653,590 Average Award: $1,421,132 Average Award: $1,746,223 Total Awarded: $15,282,647 Total Awarded: $9,921,541 Total Awarded: $8,526,789 Total Awarded: $6,984,893 13 51. Location of 50 Pilot Projects 5 Projects with Rural Focus Engaging Stakeholders to Improve Depression Management in a Tribal Health System (AK) Addressing Mental Health Needs of Rural African Americans (AR) Mobile Apps (MAPPS): Patient & Caregiver Attitudes, Behaviors, and Knowledge (CO) Integrating and Comparing Community-Based Participatory and Conjoint Analysis Approaches to Designing Behavioral Health Services (AZ) www.pcori.org 14 Boot Camp Translation for Patient- Centered Outcomes (CO) 52. One Central States project: Extension Connection: Advancing Dementia Care for Rural and Hispanic Populations (IA) (Communications and Dissemination Research program) 25 PFA Cycle I Awards 15 25 Total Awards Average Award $1,628,635 Grand Total Awarded $40,715,870 53. Key Criteria for Funding 16 Patient-Centeredness Is the proposed research focused on comparisons and outcomes that matter to patients and their caregivers? Innovation & Potential for Improvement Might the proposed research lead to changes in patient or clinician practices that lead in turn to meaningful improvement in patient health? Patient and Stakeholder Engagement Have the researchers included in their team relevant patients and other key healthcare community members, representative of those who would use its information? 54. Our First Topics for Targeted Research Funding Jump-starts our long-term effort to identify and prioritize specific research topics to study Leverages stakeholder input Ad hoc workgroup meetings available via webinar www.pcori.org/events Research Topics: Treatment Options for Severe Asthma in African-Americans and Hispanics/Latinos Treatment Options for Uterine Fibroids Preventing Injuries from Falls in the Elderly Treatment Options for Back Pain Obesity Treatment in Diverse Populations 17 55. Long-term Approach to Targeted Research: PCORI Advisory Panels 18 Will include clinicians, researchers, patients, and other experts with appropriate experience and knowledge to help us achieve our goals Will assure meaningful patient engagement in: Research activities Identifying research priorities and topics Conducting randomized clinical trials Performing special research studies Applications period closed March 4 Panels announced in late March Addressing Disparities Assessment of Prevention, Diagnosis, and Treatment Options Improving Healthcare Systems Patient Engagement 56. Key Comparative Questions in Rural Health Access to primary care, including OB/GYN, and pharmacy Role of non-physician providers Retention of providers Telemedicine, health information technology, and health information exchange Rural economic conditions Economic health of hospitals/facilities Care coordination, particularly for chronic conditions Aging, Alzheimers, heart failure, mental health, oral health, renal failure Agrimedicine/injuries Migrant health 19 57. We Want to Hear From You Are we on the right track? What are we missing? What should PCOR look like in a rural area? We want to learn from you this weekend Questions? 20 58. Building A Team: Patient/Stakeholder Researcher Matching Sue Sheridan, MIM, MBA Director, Patient Engagement March 10, 2013 59. Methodology Standards Associated with Patient-Centeredness PC-1 Engage people representing the population of interest and other relevant stakeholders in ways that are appropriate and necessary in a given research context. Stakeholders can be engaged in the processes of: Formulating research questions; Defining essential characteristics of study participants, comparators, and outcomes; Identifying and selecting outcomes that the population of interest notices and cares about (e.g., survival, function, symptoms, health-related quality of life) and that inform decision making relevant to the research topic; Monitoring study conduct and progress; and Designing/suggesting plans for dissemination and implementation activities. 2 60. 3 Video Clip: Ming Tai Seale 61. Review Criterion 7: Team and Environment (Current) Are the investigators appropriately trained and experienced to carry out the planned studies? Is the work proposed appropriate to the experience level of the principal investigator? Does the study team have complementary and integrated expertise? Is their leadership approach, governance, and organizational structure appropriate for the project? Are relevant patients and other key stakeholders of the study information appropriately involved in the design and implementation of the study? Do the experiments proposed take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional or other support? The 8 Merit Review Criteria: 1. Impact of the Condition 2. Innovation/Potential for Improvement 3. Impact on Healthcare Performance 4. Patient-Centeredness 5. Rigorous Research Methods 6. Inclusiveness of Different Populations 7. Team and Environment 8. Efficient Use of Resources 4 62. 5 Video Clip: David Thorn 63. Challenge Background PCORI is committed to meaningful patient, caregiver and stakeholder engagement as a tool for rigorous research. PCORI funding announcements require patients be fully engaged throughout research process. Engagement is among the criteria PCORI uses to score applications. 6 64. The Challenge Develop a matching system that can connect researchers and potential patient partners. Solution could be: A well-articulated conceptual model. An adaptation of existing matching protocol. A prototype or an entirely new web-based service or app. Some combination of these approaches, or something else entirely. 7 65. The Challenge Two first-place awards: Conceptual model -- $10,000 Prototype of app -- $40,000 Winners work may be considered for additional PCORI support, depending on outcome of the review process. Submission materials: slide deck (5 slides), overview doc (5 pgs), video demo (5 min), link to working app (optional) 8 66. Evaluation Criteria Technical feasibility, usability and scalability of the proposed conceptual model/prototype. Differences in ways patients, caregivers and researchers understand, describe and seek answers to problems or issues they face. Maximizing patient-centeredness & scientific rigor. Particular challenges of serving "hard-to-reach" audiences: ethnic & racial minorities, rural pops, the elderly, physically challenged and non-English speakers. 9 67. Timeline Submission period began: December 14, 2012 Submission period ends: April 15, 2013 Winners notified: May 15, 2013 Winners announced: at a major national health conference in the spring of 2013 10 68. Video Clip: Dr. Vinod Bhutani/Kris Schulze 11 69. Engagement Awards: From Partnerships to Proposals Sue Sheridan, MIM, MBA 70. Concept origin Proposed by participants at October 2012 Transforming Patient-Centered Research patient engagement workshop 13 Workshop participants identified that few resources have been directed to non research entities for community development, capacity building, or for infrastructure development for engagement in research as partners 71. Purpose 14 Expedite building community Strengthen reciprocal relationships between researchers and non- research communities Support capacity building, co- learning, creating research questions and the development of a sustainable infrastructure to facilitate research done differently Accelerate proposal submission (or re-submission) to PCORI or other PCOR related research institutes Fast track implementation 72. Design 15