Dashboard Review End of FY 2015 - PCORI€¦ · Dashboard Review End of FY 2015 Joe Selby, MD, MPH....
Transcript of Dashboard Review End of FY 2015 - PCORI€¦ · Dashboard Review End of FY 2015 Joe Selby, MD, MPH....
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Dashboard ReviewEnd of FY 2015
Joe Selby, MD, MPHExecutive Director
Michele Orza, ScDSenior Advisor to the Executive Director
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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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Our Goals: Increase Information, Speed Implementation, and Influence Research
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Budget
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Targeted
Pragmatic
Broad
Engagement
PCORNet
NANeeds Attention
On TargetOff 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 AwardedNA=Not Applicable
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By Awardees About or By PCORI
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Web Views0
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Citations
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Expected Actual
Uptake of Methodology StandardsProjects Completed as Expected
Expenditures – Total Budget, up to $362M
Phase II PFA
Released
Version 2.0 of CDM
Complete
Governance policies
approved
Aspirin Trial
Awarded
Obesity Cohort Project
Awarded
Health Systems
Convening Event
Phase II awardedQ1
2015
Q22015
Q32015
Q42015
Progress of PCORnet – Completion of Phase I
Q1=Q1 2015Q2=Q2 2015
Q3=Q3 2015Q4=Q4 2015
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Research Engagement PPRNs CDRNs
Perc
ent
Q1 Q2 Q3 Q4
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ResearchAwardsBudget
ResearchAwardsActual
All Other Budget
All OtherActual
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Q2
Q3
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*Influencing Research*A new graduate level Health Psychology course at Tulane University
is modeled on PCORI’s National Priorities for Research
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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, PhDAssistant Professor of Psychology and PsychiatryTulane 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.”
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$196
$58
FY 2014Total=$254M
$244
$50
FY 2013Total=$294M
$115
$179
$78
FY 2015Total=$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
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And the result is a substantial shift in the distribution of our portfolio
$440
$108
End of FY 2014Total=$548M
$244
$50
End of FY 2013Total=$294M
$555$179
$186
End of FY 2015Total=$920M
Broad
Pragmatic
Targeted
Funds Committed by Type of PFA, Cumulative Total by Fiscal Year
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LIST 5
LIST 1
LIST 2
LIST 3
LIST 4
LIST 6
Targeted PFA
Pragmatic PFA
LIST 7
Topic Prioritization PathwayTo 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 forTargeted PFA
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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 DiseaseReviewed 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
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Funded Projects by Primary Disease/Condition
(N=283) - Cycle I through Spring 2015
*Categories are mutually exclusive*Does not include Methods projects
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38
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Skin DiseasesAllergies and Immune Disorders
Digestive System DiseasesKidney Disease
Infectious DiseasesMuscular and Skeletal Disorders
Trauma/InjuryReproductive and Perinatal Health
Multiple/co-morbid chronic conditionsRespiratory Diseases
Neurological DisordersNutritional and Metabolic Disorders
Rare DiseasesCross-cutting
Cardiovascular HealthCancer
Mental/Behavioral Health
We have projects focusing on a wide range of conditions, with the largest concentrations in mental/behavior health and cancer
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The majority of studies in our portfolio are clinical trials
67%7%
26%
Study Design byNumber of Awards
(N=283)
Randomized Controlled Trials
Secondary Data Analysis
Observational (Prospective)
$634 M76%
$37 M4%
$168 M20%
Study Design byAward Amount ($)
Total: $838M
*Does not include Methods projects
Funded Portfolio by Study DesignCycle I through Spring 2015
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The majority of our studies focus on treatment and 18% of 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 ContinuumCycle 1 through Spring 2015
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AD18%
Methods8%
CDR7%
IHS26%
APDTO41%
Total= 355 Projects, $920M
The majority of our research funding has gone to our APTDO and IHS portfolios
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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
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The majority of our projects are on track and we are giving additional attention to those that are not
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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
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Some projects require contract modifications in order to be successfully completed
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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
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Reasons for Contract Modifications Percent of total projects by Q of FY15Number (N) of total projects differs by Q
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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 ExtensionRequired Contract Extension
88%
12%
PILOTS Completed Project within
Contract Period (N=50)
Completed in Contract Period(includes modified contracts)
Not Completed within ContractPeriod (Late)
Our First Completed Cohort of Projects
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Expected Number of Contracts Ending by Fiscal Year
Pilots
CER
Methods
We currently expect the contracts for our first cohort of 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
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The number of journal articlesconcerning PCORI increased in FY2015
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Articles Resulting from PCORI-funded Projects
Articles by or about PCORI Articles that Cite or MentionPCORI Work
Number of Articles
By Fiscal Year
2010 2011 2012 2013 2014 2015
Cumulative total=143 Cumulative total=114 Cumulative total=153
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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-adaptedtherapy 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-tailoredcoaching 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 largelyuninsured patients with knee osteoarthritis
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Citations of Methodology StandardsBy Calendar Year
Measures of Uptake of Our Methodology Standards:We are tracking citations and other early indicatorsExample – 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
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Measures of Uptake of Our Methodology Standards:In FY2016, we will be tracking PCORI-Funded CME/CEOur 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 1Basic Context, Role, and Development of Standards in CER
Module 2Role of Standards in PCORI Funding Announcements & the Application Process
Module 3Formulating Research Questions and Patient Centeredness
Module 4Data Integrity, Preventing and Handling Missing Data, and Heterogeneity of Treatment Effects
Module 5Data Registries, Data Networks, and Causal Inference
Module 6Standards for Specific Study Designs- Adaptive and Bayesian Trial Designs and Diagnostic Tests
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Joel M. Gelfand, MD, MSCECenter for Clinical Epidemiology & BiostatisticsPerelman School of MedicineUniversity 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 inPatient-Centered Outcomesand Effectiveness Research
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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?
Slide Number 1Slide Number 2Slide Number 3Slide Number 4Slide Number 5And the result is a substantial shift in the distribution of our portfolioSlide Number 7Slide Number 8Funded Projects �by Primary Disease/Condition�(N=283) - Cycle I through Spring 2015The majority of studies in our portfolio are clinical trialsThe majority of our studies focus on treatment and 18% of our funding is in screening and prevention studiesSlide Number 12Slide Number 13Slide Number 14Slide Number 15Slide Number 16Slide Number 17The number of journal articles concerning PCORI increased in FY2015Three Published Protocols for CER StudiesSlide Number 20Slide Number 21Slide Number 22Slide Number 23