Dashboard Review End of FY 2015 Joe Selby, MD, MPH Executive - - PowerPoint PPT Presentation

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
• ver the next four years?
• Is our approach to targeted topics optimal?

Our Goals: Increase Information, Speed Implementation, and Influence Research

100 200 300 400 500 600

Actual Budget

$ Millions Q1 Q2 Q3 Q4

10 20 30

Q1 Q2 Q3 Q4 Number of Projects

Targeted Pragmatic Broad Engagement PCORNet

NA

Needs Attention On Target Off Target

Legend Funds Committed to Research – up to $640M Percent of Projects on Track

Board of Governors FY2015 Dashboard – Q4 (As of 9/30/2015)

Journal Articles Published Projects Awarded

NA=Not Applicable

5 10 15 20 25 30 35 By Awardees About or By PCORI Number of Articles

Q1 Q2 Q3 Q4

1,000 2,000 3,000 4,000 5,000 Web Views 5 10 15 Citations

Q1 Q2 Q3 Q4

5 10 15 20 25 30

Q1 Q2 Q3 Q4

Number of Projects Expected Actual

Uptake of Methodology Standards Projects Completed as Expected Expenditures – Total Budget, up to $362M Phase II PFA Released Version 2.0

• f CDM

Complete Governance policies approved Aspirin Trial Awarded Obesity Cohort Project Awarded Health Systems Convening Event Phase II awarded

Q1

2015

Q2

2015

Q3

2015

Q4

2015

Progress of PCORnet – Completion of Phase I

Q1=Q1 2015 Q2=Q2 2015 Q3=Q3 2015 Q4=Q4 2015

10 20 30 40 50 60 70 80 90 100 Research Engagement PPRNs CDRNs Percent

Q1 Q2 Q3 Q4

NA NA Research Awards Budget Research Awards Actual All Other Budget All Other Actual

50 100 150 200 250 $ Millions

Q1 Q2 Q3 Q4

*Influencing Research* A new graduate level Health Psychology course at Tulane University is modeled on PCORI’s National Priorities for Research

Goal 3 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 6 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.”

$196 $58 FY 2014 Total=$254M $244 $50 FY 2013 Total=$294M $115 $179 $78 FY 2015 Total=$372M

Broad Pragmatic Targeted

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

And the result is a substantial shift in the distribution of our portfolio

$440 $108 End of FY 2014 Total=$548M $244 $50 End of FY 2013 Total=$294M $555 $179 $186 End of FY 2015 Total=$920M

Broad Pragmatic Targeted

Funds Committed by Type of PFA, Cumulative Total by Fiscal Year

LIST 5

LIST 1 LIST 2 LIST 3

LIST 4

LIST 6

Targeted PFA Pragmatic PFA

LIST 7

Topic Prioritization Pathway

To make list 1, Staff determine topic eligibility To make list 2, SOC reviews and endorses topics for topic briefs To make list 4, Advisory Panel reviews & prioritizes topics To make list 5, SOC endorses topics for further refinement To make list 3, SOC reviews topic briefs and approves them for Advisory Panel review To make lists 6&7, SOC assigns questions to Targeted or Pragmatic PFA SOC reviews and approves questions for Pragmatic PFA Board reviews and approves for Targeted PFA

Topic Prioritization Pathway: FY15 Q4 Snapshot

Under Consideration Approved Topics Funded Topics

For Targeted PFAs (List 6)

• Chronic Pain/Long Term Opioid Therapy
• Multiple Sclerosis
• NOACs for blood clots
• Treatment-Resistant Depression

Funded via Targeted PFAs

• 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

SOC Endorsed for Refinement (List 5)

• Asthma
• Chronic Low Back Pain
• Diabetes
• Mental Health Integration
• Palliative Care
• Sickle Cell Disease

Reviewed by Advisory Panels (List 4)

• 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

For Pragmatic Studies PFAs (List 7)

• Autism Spectrum Disorders-

behavioral 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

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

Funded Projects by Primary Disease/Condition

(N=283) - Cycle I through Spring 2015

*Categories are mutually exclusive *Does not include Methods projects

1 2 3 8 10 11 12 12 16 17 19 20 21 22 26 40 43 10 20 30 40 50 Skin Diseases Allergies and Immune Disorders Digestive System Diseases Kidney Disease Infectious Diseases Muscular and Skeletal Disorders Trauma/Injury Reproductive and Perinatal Health Multiple/co-morbid chronic conditions Respiratory Diseases Neurological Disorders Nutritional and Metabolic Disorders Rare Diseases Cross-cutting Cardiovascular Health Cancer Mental/Behavioral Health

We have projects focusing on a wide range of conditions, with the largest concentrations in mental/behavior health and cancer

The majority of studies in our portfolio are clinical trials

67% 7% 26%

Study Design by Number of Awards (N=283)

Randomized Controlled Trials Secondary Data Analysis Observational (Prospective) $634 M 76% $37 M 4% $168 M 20%

Study Design by Award Amount ($) Total: $838M

*Does not include Methods projects

Funded Portfolio by Study Design

Cycle I through Spring 2015

The majority of our studies focus on treatment and 18%

• f our funding is in screening and prevention studies

82% 10% 4% 2% 2%

Care Continuum by Proportion of Projects N=283

Treatment Prevention Screening Diagnosis Other 77% 14% 4% 3% 3%

Care Continuum by Proportion of Funding Total: $838M

*Does not include Methods Projects

Funded Portfolio by Care Continuum

Cycle 1 through Spring 2015

AD 18% Methods 8% CDR 7% IHS 26% APDTO 41%

Total= 355 Projects, $920M

The majority of our research funding has gone to our APTDO and IHS portfolios

We actively monitor our projects, support them to be successful, and classify their progress as shown below

The “Percent of Projects on Track” shown on the Dashboard is the percent of projects in the green zone

• AND-
• AND-
• AND-
• OR-
• OR-
• OR-
• OR-
• OR-
• OR-

The majority of our projects are on track and we are giving additional attention to those that are not

130 180 183 47 54 67 16 9 11 11 14 13 1 1

25 50 75 100 125 150 175 200 225 250 275 300

Q2 2015 Q3 2015 Q4 2015

Number of Projects

Distribution of Project Status by Quarter

Green Zone Yellow Zone Orange Zone Red Zone Award Terminated* *Notice of Termination Issued

Some projects require contract modifications in order to be successfully completed

6 7 8 12 4 5 8 3 2 2 5 2 2 5 10 15 20 25 30 35 40

Milestones Scope of Work Period of Performance Budget (Increase) Q1 (N=195) Q2 (N=222) Q3 (N=259) Q4 (N=278)

• Includes all research projects with at least one progress report due
• Does not include infrastructure or pilot projects

%

Reasons for Contract Modifications

Percent of total projects by Q of FY15

Number (N) of total projects differs by Q

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

54% 46% PILOTS Contract Extensions (N=50) No Extension Required Contract Extension 88% 12% PILOTS Completed Project within Contract Period (N=50) Completed in Contract Period (includes modified contracts) Not Completed within Contract Period (Late)

Our First Completed Cohort of Projects

3 47 1 40 127 46 21 2 11 3 36 19 8 20 40 60 80 100 120 140 2014 2015 2016 2017 2018 2019 2020 2021

Fiscal Year

Expected Number of Contracts Ending by Fiscal Year

Pilots CER Methods

We currently expect the contracts for our first cohort

• f CER studies to end late in FY 2016

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

3 6 10 1 18 17 5 11 9 27 30 33 110 46 84 20 40 60 80 100 120 Articles Resulting from PCORI- funded Projects Articles by or about PCORI Articles that Cite or Mention PCORI Work

Number of Articles By Fiscal Year

2010 2011 2012 2013 2014 2015

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

10 21 31 26 5 10 15 20 25 30 35

2012 2013 2014 2015

Number

Citations of Methodology Standards By Calendar Year

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.

JAMA Statistics

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 6 Modules Released Sept 30, 2015 Module 1 Basic Context, Role, and Development of Standards in CER Module 2 Role of Standards in PCORI Funding Announcements & the Application Process Module 3 Formulating Research Questions and Patient Centeredness Module 4 Data Integrity, Preventing and Handling Missing Data, and Heterogeneity of Treatment Effects Module 5 Data Registries, Data Networks, and Causal Inference Module 6 Standards for Specific Study Designs- Adaptive and Bayesian Trial Designs and Diagnostic Tests

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

Measures of Uptake of Our Methodology Standards: Incorporation into academic curriculum – Example

Class Topic 1 Overview of PCOR: PCORI Methodology Report 2 Formulating Research Questions, Identifying Evidence Gaps 3 Patient Centeredness: Stakeholder Engagement 4 Patient Centeredness: Methods to Increase Patient Enrollment 5 Patient Centeredness: Selection of Outcomes, PROs 6 Sensitivity Analyses 7 Missing Data 8 Data Registries & Automated Databases for CER 9 Pragmatic Trials & Bayesian Designs

EPID 624: Methods in Patient-Centered Outcomes and Effectiveness Research

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?