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Dashboard Review End of FY 2015 Joe Selby, MD, MPH Executive Director Michele Orza, ScD Senior Advisor to the Executive Director Discussion Questions • What is your view of our performance in FY 2015 and our status as of the end of FY 2015? • What are your thoughts about our funding commitments over the next four years? • Is our approach to targeted topics optimal? Q2 Q3 Targeted 30 Broad 20 Actual Engagement PCORNet 10 100 200 300 400 $ Millions 500 600 100 90 80 70 60 50 40 30 20 10 Pragmatic Number of Projects Budget Q1 Projects Completed as Expected Q2 Q3 Q1 Actual 30 Q2 25 25 20 15 10 Q2 Q3 Q4 20 Q4 15 Q2 All Other Budget NA Q4 NA Engagement PPRNs CDRNs 15 5,000 Q1 Q2 4,000 Q3 10 3,000 Q4 10 1,000 By Awardees Q1 Q3 2,000 About or By PCORI Web Views Citations Progress of PCORnet – Completion of Phase I Expenditures – Total Budget, up to $362M Research Awards Budget Research Awards Actual Q2 Q3 Q1 Q3=Q3 2015 Q4=Q4 2015 Uptake of Methodology Standards Journal Articles Published Number of Articles Number of Projects Expected NA=Not Applicable Q1 Research Q4 35 30 NA Needs Attention Q1=Q1 2015 Q2=Q2 2015 Percent of Projects on Track Projects Awarded Q4 Legend Off Target Our Goals: Increase Information, Speed Implementation, and Influence Research Funds Committed to Research – up to $640M Q1 On Target Percent Board of Governors FY2015 Dashboard – Q4 (As of 9/30/2015) *Influencing Research* A new graduate level Health Psychology course at Tulane University is modeled on PCORI’s National Priorities for Research Obesity Cohort Project Awarded Governance policies approved Phase II PFA Released Health Systems Convening Event Q3 Q4 All Other Actual 50 100 150 $ Millions 200 250 Version 2.0 of CDM 2015 Complete Q1 Q2 2015 Aspirin Trial Awarded Q3 2015 Phase II awarded Q4 2015 Goal Results: PCORI Influence on Curriculum *Influencing Research* A new graduate level Health Psychology course at Tulane University is modeled on PCORI’s National Priorities for Research Michael Hoerger, PhD Assistant Professor of Psychology and Psychiatry Tulane University Designed a new Health Psychology course for the Masters Program in Behavioral Health based on PCORI’s National Priorities for Research • • • Course objective: prepare students for doctoral training in psychology so that they can ultimately pursue careers in clinical practice, research, and policy 10 modules, with focused on PCORI Hoerger, M (2015) Educating the Psychology Workforce in the Age of the Affordable Care Act: A Graduate Course Modeled After the Priorities of the Patient-Centered Outcomes Research Institute (PCORI) Training and Education in Professional Psychology E-pub ahead of print “PCORI’s five national priorities are noteworthy for psychologists and psychology trainees in terms of suggesting potential funding areas and clarifying trends in US healthcare for psychologists.” We are making progress on our Strategic Priority to “Increase the proportion of research funding going to focused and targeted topics” Funds Committed in Each Fiscal Year by Type of PFA FY 2013 Total=$294M FY 2014 Total=$254M FY 2015 Total=$372M Broad Pragmatic Targeted $50 $78 $58 $244 $115 $196 $179 And the result is a substantial shift in the distribution of our portfolio Funds Committed by Type of PFA, Cumulative Total by Fiscal Year End of FY 2013 Total=$294M End of FY 2015 Total=$920M End of FY 2014 Total=$548M Broad Pragmatic Targeted $186 $108 $50 $179 $244 $440 $555 Topic Prioritization Pathway LIST To make list 1, Staff determine topic eligibility LIST To make list 2, SOC reviews and endorses topics for topic briefs To make list 3, SOC reviews topic briefs and approves them for Advisory Panel review LIST To make list 4, Advisory Panel reviews & prioritizes topics LIST LIST To make list 5, SOC endorses topics for further refinement To make lists 6&7, SOC assigns questions to Targeted or Pragmatic PFA Board reviews and approves for Targeted PFA SOC reviews and approves questions for Pragmatic PFA LIST LIST Targeted PFA Pragmatic PFA Topic Prioritization Pathway: FY15 Q4 Snapshot Under Consideration Approved Topics Funded Topics SOC Endorsed for Refinement (List 5) Funded via Targeted PFAs • • • • • • Asthma Chronic Low Back Pain Diabetes Mental Health Integration Palliative Care Sickle Cell Disease For Targeted PFAs (List 6) • • • • • • • • • • • • • • • • • • • • • • • • • Antimicrobial Resistance Autism Spectrum Disorders- risk assessment NOACs for stroke prevention Care coordination Cognitive Impairment Communication Coronary Artery Disease- Statins Dementia Genetic Testing for Rare Disease Glaucoma Health IT & Evidence-Based Treatment High Cholesterol Implantable Cardiac Defibrillators Links btw Providers & Community Neck Pain Orthopedic Surgery Pneumonia Post-Acute Care Transitions Role of Spacers in Asthma Substance Abuse- Adolescents/Alcohol Weight Maintenance & Reduction • • • • • • • Reviewed by Advisory Panels (List 4) Chronic Pain/Long Term Opioid Therapy Multiple Sclerosis NOACs for blood clots Treatment-Resistant Depression For Pragmatic Studies PFAs (List 7) • Autism Spectrum Disordersbehavioral analysis • Cardiovascular Disease • Caregiver Engagement & Support • Carotid Artery Disease • Dental Caries • Diabetes • End Stage Renal Disease • Insurance Design • Medication Management • Migraine • Musculoskeletal Pain • Opioid Abuse Treatment • Osteoarthritis • Pelvic Floor Dysfunction • Pre-term & Low Birth Weight • Suicide Prevention • Tobacco Use Prevention & Cessation • Traumatic Brain Injury CAD-Aspirin Dose Care Transitions Falls in Elderly Hepatitis C- New Therapies Hypertension Obesity in Diverse Populations Severe Asthma in African Americans & Hispanics • Uterine Fibroids Funded via Pragmatic PFAs • • • • • • • • Bipolar Disorder Breast Ductal Carcinoma in Situ Crohn’s Disease- Biologics Chronic Back Pain Hip Fractures Mental Health & Primary Care Particle Beam Therapy Pulmonary Nodules & CT Surveillance We have projects focusing on a wide range of conditions, with the largest concentrations in mental/behavior health and cancer Funded Projects by Primary Disease/Condition (N=283) - Cycle I through Spring 2015 Mental/Behavioral Health 43 Cancer 40 Cardiovascular Health 26 Cross-cutting 22 Rare Diseases 21 Nutritional and Metabolic Disorders 20 Neurological Disorders 19 Respiratory Diseases 17 Multiple/co-morbid chronic conditions 16 Reproductive and Perinatal Health 12 Trauma/Injury 12 Muscular and Skeletal Disorders 11 Infectious Diseases 10 Kidney Disease Digestive System Diseases Allergies and Immune Disorders Skin Diseases 10 20 30 40 *Categories are mutually exclusive *Does not include Methods projects 50 The majority of studies in our portfolio are clinical trials Funded Portfolio by Study Design Cycle I through Spring 2015 Study Design by Number of Awards (N=283) Study Design by Award Amount ($) Total: $838M 26% $37 M 4% 7% $168 M 20% 67% $634 M 76% Randomized Controlled Trials Secondary Data Analysis Observational (Prospective) *Does not include Methods projects The majority of our studies focus on treatment and 18% of our funding is in screening and prevention studies Funded Portfolio by Care Continuum Cycle through Spring 2015 Care Continuum by Proportion of Projects N=283 Care Continuum by Proportion of Funding Total: $838M 4% 2% 2% 4% 10% 3% 3% 14% 77% 82% Treatment Prevention Screening Diagnosis Other *Does not include Methods Projects The majority of our research funding has gone to our APTDO and IHS portfolios Total= 355 Projects, $920M AD 18% APDTO 41% Methods 8% CDR 7% IHS 26% We actively monitor our projects, support them to be successful, and classify their progress as shown below -AND- -AND- -AND- -OR- -OR- -OR- -OR- -OR- -OR- The “Percent of Projects on Track” shown on the Dashboard is the percent of projects in the green zone The majority of our projects are on track and we are giving additional attention to those that are not Distribution of Project Status by Quarter Q4 2015 11 13 67 183 Q3 2015 14 54 180 Green Zone Yellow Zone Q2 2015 Orange Zone 16 11 47 130 Red Zone Award Terminated* 25 50 75 100 125 150 175 200 225 250 275 300 Number of Projects *Notice of Termination Issued Some projects require contract modifications in order to be successfully completed 40 Reasons for Contract Modifications Percent of total projects by Q of FY15 35 Number (N) of total projects differs by Q 30 % Q1 (N=195) Q2 (N=222) Q3 (N=259) Q4 (N=278) 25 20 15 12 10 5 2 Milestones Scope of Work 0 Period of Performance Budget (Increase) • Includes all research projects with at least one progress report due • Does not include infrastructure or pilot projects Almost half of our first completed cohort of studies (the Pilot Projects, average length 26 months) required an extension (5 months on average) and 88% were then completed within the contract period Our First Completed Cohort of Projects PILOTS Contract Extensions (N=50) PILOTS Completed Project within Contract Period (N=50) 12% 46% 54% 88% No Extension Required Contract Extension Completed in Contract Period (includes modified contracts) Not Completed within Contract Period (Late) We currently expect the contracts for our first cohort of CER studies to end late in FY 2016 Expected Number of Contracts Ending by Fiscal Year 140 127 Pilots 120 CER 100 Methods 80 60 47 46 40 40 36 19 20 2014 2015 21 2016 2017 2018 Fiscal Year 2019 11 2020 2021 Includes completed contract modifications; Does not include pending modifications to incorporate peer review of draft final research report The number of journal articles concerning PCORI increased in FY2015 2010 2011 2012 2013 2014 2015 120 110 100 84 Number of Articles 80 By Fiscal Year 60 46 40 18 20 33 30 27 17 11 0 10 Articles Resulting from PCORIfunded Projects Articles by or about PCORI Articles that Cite or Mention PCORI Work Cumulative total=143 Cumulative total=114 Cumulative total=153 Three Published Protocols for CER Studies Field CA, et al Cultural adaptation of a brief motivational intervention for heavy drinking among Hispanics in a medical setting BMC Public Health 2015 Jul 30;15:724 Culturally-adapted therapy vs non-adapted therapy for heavy drinking among Latino men Taveras EM, et al Connect for health: Design of a clinical-community childhood obesity intervention testing best practices of positive outliers Contemp Clin Trials 2015 Sep 28 Contextually-tailored health coaching vs non-tailored coaching for weight loss in obese children ages 2-12 years Williams QI, et al Physical therapy vs internet-based exercise training (PATH-IN) for patients with knee osteoarthritis: study protocol of a randomized controlled trial BMC Musculoskelet Disord 2015 Sep 28;16(1):264 Standard physical therapy vs internet-based training for largely uninsured patients with knee osteoarthritis Measures of Uptake of Our Methodology Standards: We are tracking citations and other early indicators Example – Citations, Page-views, and Downloads of: Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI) Methodological standards and patient-centeredness in comparative effectiveness research: the PCORI perspective JAMA 2012 Apr 18;307(15):1636-40 Citations of Methodology Standards By Calendar Year 35 30 26 25 Number JAMA Statistics 31 21 20 15 10 10 2012 2013 2014 2015 Measures of Uptake of Our Methodology Standards: In FY2016, we will be tracking PCORI-Funded CME/CE Our CME/CE activity is designed to introduce PCORI’s Methodology Standards, review the development and types of standards, and provide context and guidance for adherence relevant to the use and application of these standards in research and in responding to PCORI funding announcements PCORI Methodology Standards Series with Modules Released Sept 30, 2015 Module Basic Context, Role, and Development of Standards in CER Module Role of Standards in PCORI Funding Announcements & the Application Process Module Formulating Research Questions and Patient Centeredness Module Data Integrity, Preventing and Handling Missing Data, and Heterogeneity of Treatment Effects Module Data Registries, Data Networks, and Causal Inference Module Standards for Specific Study Designs- Adaptive and Bayesian Trial Designs and Diagnostic Tests Measures of Uptake of Our Methodology Standards: Incorporation into academic curriculum – Example Joel M Gelfand, MD, MSCE Center for Clinical Epidemiology & Biostatistics Perelman School of Medicine University of Pennsylvania MSCE with Concentration in Patient-Centered Outcomes Research (PCOR) • • • Students explore methods spanning qualitative research, clinical epidemiology, molecular epidemiology, and clinical trials Unifying theme is generation of data that helps patients, their care givers, providers, and health care delivery systems make informed health care decisions that improve outcomes that matter most to patients Students expected to pursue a thesis relevant to patient-centered outcomes research Class EPID 624: Methods in Patient-Centered Outcomes and Effectiveness Research Topic Overview of PCOR: PCORI Methodology Report Formulating Research Questions, Identifying Evidence Gaps Patient Centeredness: Stakeholder Engagement Patient Centeredness: Methods to Increase Patient Enrollment Patient Centeredness: Selection of Outcomes, PROs Sensitivity Analyses Missing Data Data Registries & Automated Databases for CER Pragmatic Trials & Bayesian Designs Discussion Questions • What is your view of our performance in FY 2015 and our status as of the end of FY 2015? • What are your thoughts about our funding commitments over the next four years? • Is our approach to targeted topics optimal?

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