ANNUALMEETING
OCT. 31-NOV. 2ARLINGTON, VA
#PCORI2017
Addressing the Opioid Crisis by Improving Pain Management
Christine Goertz, DC, PhDVice Chancellor for Research and Health Policy at Palmer College of Chiropractic and Chief Executive Officer of the Spine Institute for Quality@ChristineGoertzNovember 1, 2017
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Christine Goertz, DC, PhDDisclosures
Relationship Company(ies)
Speakers Bureau
Advisory Committee Quality Insights of Pennsylvania Technical Expert Panel #’s 131, 182
Consultancy American Chiropractic Association, Healthwise, Inc., Quality Insights of Pennsylvania, RANDCorporation
Review Panel
Board Membership American Public Health Association, Chiropractic & Manual Therapies, Journal of Manipulative and Physiological Therapeutics, PCORI Board of Governors
Honorarium
Ownership Interests Prezacor, Inc.
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ObjectivesAt the conclusion of this activity, participants should be able to:• Understand the nature and extent of the opioid crisis and what
is known about the benefits and harms of opioids, non-opioid alternatives to pain management, and treatment for opioid use disorder
• Identify evidence patients and other stakeholders need to help them make better choices about managing pain
• Have a broad overview of PCORI’s investments in opioid and pain-related research and how two specific PCORI projects address evidence gaps
ANNUALMEETING
OCT. 31-NOV. 2ARLINGTON, VA
#PCORI2017
Christine Goertz, DC, PhDPCORI Board of Governors
Judy Zerzan, MD, MPHColorado Department of Healthcare Financing and Healthcare
Aleksandra Zgierska, MD, PhDUniversity of Wisconsin
Terrie CowleyThe TMJ Association, Ltd
Erin Krebs, MD, MPHUniversity of Minnesota
Lynn Debar, PhDKaiser Permanente
ANNUALMEETING
OCT. 31-NOV. 2ARLINGTON, VA
#PCORI2017
Overview of Opioid Crisis and Effective Nonpharmacologic Treatment Strategies for Pain
Erin E. Krebs, MD, MPHMinneapolis VA Health Care System, University of MinnesotaNovember 1, 2017
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Erin Krebs
Has nothing to disclose.Is speaking for herself, not for the VA or US government.
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ObjectivesAt the conclusion of this activity, participants should be able to describe:• Scope of the opioid crisis and its intersection with pain
management• Evidence for nonopioid pain therapies and opioid tapering• Key gaps and research needed to advance our knowledge of the
comparative effectiveness of strategies to address the opioid crisis
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Paulozzi et al, MMWR 2011;60:1487–92
Opioid overdose deaths
Opioid addiction treatment admissions
Opioid sales
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The Evidence for Opioids in Chronic Pain, 1996
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Management of Opioid Therapy for Chronic Pain Working Group, March 2003
Opinion of respected authorities, case reports, and expert committees
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Clin J Pain. 1997 Mar;13(1):6-8.
• “It is now accepted by practitioners of the specialty of pain medicine that respiratory depression induced by opioids tends to be a short-lived phenomenon, generally occurs only in the opioid-naive patient, and is antagonized by pain.”
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The Evidence for Opioids in Chronic Pain, 2016
• No study of opioid therapy versus placebo, no opioid therapy, or nonopioid therapy for chronic pain evaluated long-term (≥ 1 year) outcomes related to pain, function, or quality of life.
• Most placebo-controlled randomized clinical trials were ≤ 6 weeks in duration
Dowell D et al, MMWR 2016; 65(1);1–49
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Intertwined challenges of the opioid crisis
Chronic pain
Opioid addiction
Long-term opioid use
How can people prescribed high-dose opioids reduce opioid dosages and decrease risk of harm, while managing pain?
How can people with chronic pain find the best approaches to pain management for their situation?
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• Prompted by White House summit on opioid crisis• Focus on alternatives to opioid therapy• Goals: Synthesize existing evidence to identify approaches with
sufficient evidence (ready for use) and areas needing future research
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Behavioral therapies
CBTACT
MBSR
Manual therapiesMassage
AcupunctureManipulation
Exercise therapies
Strengthening-stretching
Aerobic exerciseYoga
Tai chi
Therapies with evidence of efficacy
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Areas needing additional research
• Selecting therapies• Combining and sequencing therapies• Dose/duration of therapies• Engaging and activating patients
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The evidence for opioids in chronic pain, 2016
• Findings• Interdisciplinary pain programs and multimodal behavioral
interventions may be effective in reducing opioid dose• Pain, function, and quality of life may improve during and
after opioid dose reduction• Overall, very low quality of evidence
Frank JW et al. Ann Intern Med 2017;167:181-191
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The evidence for opioids in chronic pain, 2016
• Research needs include:• Studies using innovative designs to overcome research
challenges (e.g., recruitment) • Testing more feasible/scalable treatment approaches • Studies to examine real-world changes in practice and
policy
Frank JW et al. Ann Intern Med 2017;167:181-191
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Future directions for research
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PCORI’s Investment in Pain and Opioid Research
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Christine Goertz, DC, PhDVice Chancellor for Research and Health Policy at Palmer College of Chiropractic and Chief Executive Officer of the Spine Institute for Quality@ChristineGoertzNovember 1, 2017
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PCORI’s MissionTo help people make informed healthcare decisions and improve healthcare delivery and outcomes, by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community.
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PCORI’s Role in a National Health Research Program
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PCORI Priority Area: Chronic Pain and Opioid Research
Development of Key Initiatives on Pain and Opioid
Research
Stakeholder Workshops:
Define CER Questions
Board Priority Area: Chronic Pain/Opioid
Crisis
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Research Addressing Questions That MatterClinicianWhat works best to safely and appropriate reduce opioid use for people with pain?
PatientI’m worried about becoming dependent on opioids. How effective are nondrug options for treating pain?
Health System LeaderHow can we improve our clinicians’ prescribing practices?
CaregiverHow can patients best become empowered about opioid use?
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59 studies related to chronic noncancer pain and/or opioids
209 million to fund
As of October 2017, PCORI has awarded
Chronic and Acute Pain Management
ANNUALMEETING
OCT. 31-NOV. 2ARLINGTON, VA
#PCORI2017
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Spanning the Care Continuum
Prevention Treatment Alternatives
Education and Communication
Management of Long-term Opioid
Use
Treatment for Opioid Use
Disorder
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PCORI’s Targeted Opioid Initiatives
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Strategies to Prevent Unsafe Prescribing in Primary Care among Patients with Acute or Chronic Pain
Funds and Duration:
• $30 million originally available (direct and indirect)
• Up to $5 million in total direct costs per project
• Projects should be completed within 3 years
Objective of this PFA:• Prevent unsafe opioid prescribing while
ensuring adequate pain management utilizing:
• health system or payer strategies
• patient and provider communication interventions addressing benefits and harms of treatments
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Clinical Strategies for Managing and Reducing Long-Term Use for Chronic Pain
Objective of this PFA:• Identify clinical strategies for managing
pain while:
• Reducing or eliminating long-term opioid use
• Limiting dose escalation
Funds and Duration:
• A total of $40 million (direct and indirect)
• Up to $10 million in total direct costs per project
• Projects should be completed within 3-5 years
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Medication-Assisted Treatment Delivery for Pregnant Women with Substance Use Disorders Involving Prescription Opioids and/or Heroin
Objective of this PFA:• Generate evidence about different
models of MAT delivery to pregnant women with substance use disorder:
• Comprehensive care models that include prenatal care, MAT, and psychosocial support
• Remotely supported treatment delivery with varying levels of office-based induction and psychosocial support
Funds and Duration:
• A total of $16 million (direct and indirect)
• Up to $4 million in total direct costs per project
• Projects should be completed in 3-4 years
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In Summary:• PCORI is taking a holistic approach; a one-size-fits-all approach
cannot answer all the patient, clinician, caregiver, and policymaker questions that need to be addressed
• As a patient-centered organization, PCORI research is committed to both addressing effective pain management and reducing harms associated with opioid use
• Addressing this challenge will require ongoing collaboration with all stakeholders
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Questions?
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Thank You!
Christine Goertz, DC, PhDVice Chancellor for Research and Health Policy at Palmer College of Chiropractic and Chief Executive Officer of the Spine Institute for Quality
@ChristineGoertz
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What Evidence Do Patients Need For Improved Pain Management?
Terrie CowleyPresident and Co-Founder, The TMJ AssociationCo-Founder, The Chronic Pain Research Alliance
https://twitter.com/tmjassociationhttps://twitter.com/CPRAlliance_org
November 1, 2017
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Terrie CowleyChronic Pain Research Alliance has received a $10,000 grant from Purdue Pharma L.P. on December 13, 2016, for a Patient Guide to Improve Pain Function and Quality of Life for those with Chronic Overlapping Pain Conditions.
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ObjectivesAt the conclusion of this activity, participants should be able to:• Understand what we know about pain treatments and the
uncertainty patients face regarding pain management options• Learn about the evidence needs of chronic pain patients
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Patients have told us….
“I wish I had cancer because then my family and friends would understand…”
Individually and collectively we have a moral imperative to address the impact of and response to pain in America. People in pain need a cultural transformation in the way pain is viewed and treated. Source: Relieving Pain in America IOM Report
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The CPRA is an initiative of The TMJ Association
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• Pain treatment is haphazard, trial and error• Pain treatment is fragmented and treated by an array
of various professionals• Many long-used treatments and new complementary
therapies lack scientific rigor for pain in general as well as specific conditions
• Most research on pain management does not look at long-term outcomes, so there is really a lack of evidence on how to improve pain management while reducing risk to patients
What do we know about pain treatment?
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Benefit vs. Risk
ANNUALMEETING
OCT. 31-NOV. 2ARLINGTON, VA
#PCORI2017
What evidence do patients need?
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Evidence of effectiveness of various nonpharmacologic/non-opioid options
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Large clinical trials that include patients with comorbidities-what works best for patients like me?
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Time for one-person trials
Precision medicine requires a different type of clinical trial that focuses on individual, not average, responses to therapy, says Nicholas J. Schork
Schork, Nicholas J. “Personalized medicine: Time for one-person trials.” Nature 520.7549 (2015): 609-611.
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Patient involvement in all aspects of pain research
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Improved communication between patients and providers
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The Way Forward
Identify Decisional Dilemmas
Conduct CER Generate Evidence Base
Improve Education and
Communication
Improve Reimbursement
Reduce Uncertainty &
Improve Outcomes
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Learn more
www.tmj.orgchronicpainresearchalliance.org
#PCORI2017
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Questions?
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Thank you!
Terrie CowleyWhat Evidence Do Patients Need?https://twitter.com/tmjassociationhttps://twitter.com/CPRAlliance_orgNovember 1, 2017
ANNUALMEETING
OCT. 31-NOV. 2ARLINGTON, VA
#PCORI2017
Preventing Unsafe Opioid Prescribing
Lynn DeBar, PhD, MPHSenior Scientific Investigator, Kaiser Permanente Washington Health Research Institute
November 1, 2017
ANNUAL MEETING | #PCORI2017
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Lynn DeBar
• Has nothing to disclose.
November 5, 2017
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ObjectivesAt the conclusion of this activity, participants should be able to:
• Understand how the opioid crisis is affecting some states and what one state is doing to address the issue
• Outline the design of a PCORI-funded study to measure the effectiveness of a State Medicaid program change on preventing unsafe prescribing and improving management of low back pain
• Describe the potential impact of the study
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Opioids and Beyond: What happened to nonpharmacotherapy options for chronic pain?
November 5, 2017
ANNUAL MEETING | #PCORI2017
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Oregon Medicaid Reimbursement Guidelines for Back Pain• Focus on biopsychosocial model
• Add coverage for evidence-based effective treatments• i.e., cognitive behavioral therapy (CBT), osteopathic or chiropractic
manipulative therapy, exercise-based therapies (including those offered in multidisciplinary intensive rehabilitation settings)
• Restrict or eliminate ineffective or potentially unsafe treatments• Opioids• Epidural steroid injections• Surgery limited to conditions with known effectiveness
November 5, 2017
OTC meds, muscle relaxers
4 visitsPT/OT/OMT/
Chiro/Acupuncture/massage
Low RiskOTC meds,
muscle relaxers
4 visitsPT/OT/OMT/
chiro/acupuncture/massage
OTC meds, muscle relaxers
High Risk
OTC meds, muscle relaxers,limited opioids
CBT
Office visitsOffice visits
Up to 30 visitsPT/OT/OMT/
chiro/acupuncture
If available:yoga,
interdisciplinary rehab, supervised exercise, massage
Not Recommended:First-line opioid
prescribing or long-term opioid use
Oregon Medicaid: New Back Pain Treatment Pathways
ANNUAL MEETING | #PCORI2017
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Timeline for Oregon Guideline Implementation
November 5, 2017
July 1, 2016Start of new coverage for
non-opioid evidence-based therapies for back pain
January 1, 2017 For patients already on
chronic opioid treatment, taper plan with non-
pharmacologic treatment required
January 1, 2018 End to transitional coverage
of opioids for patients already on chronic opioid
treatment
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Goal: Evaluate impact of Oregon Medicaid Reimbursement
Guidelines for Back Pain
Substudy A: Compare opioid prescribing and use of other pain-
related health services(electronic health record)
Substudy B: Compare patient-centered outcomes
(patient surveys)
Substudy C: Understand contextual factors underlying successes and
challenges(qualitative data collection)
Oregon
California
Back on Track Study
ANNUAL MEETING | #PCORI2017
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Study Setting: OCHIN
November 5, 2017
HRSA-designated nonprofit Health Center Controlled Network of federally qualified health centers
Supports organizations in all 50 states, partnering with 289 organizations with 10,000 clinicians serving over 10 million patients.
ANNUAL MEETING | #PCORI2017
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Patient Survey Content (Provisional)
November 5, 2017
Pain and Functioning Services Received and Satisfaction
Adverse Events
Brief Pain Inventory – SF
STarT Back Screening Tool
Pain bothersomeness
Patient global impression of change
Evidence-based services (covered by guidelines) received in past 3 months
Satisfaction with services to manage back pain
Satisfaction with outcome of pain-related services
Negative outcomes from pain-related services
Use of illegal drugs or Rx meds for nonmedical reasons
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Engaging Patient and Stakeholder Partners
• Bullet
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Back on Track – Potential Impact
• Help reduce inappropriate prescribing of opioids in a vulnerable, socioeconomically disadvantaged population, especially among those at high risk for misuse and abuse
• Payers:• Potential to encourage widespread adoption (Medicaid insured and
broader healthcare systems)
• Patients:• Potential access to broad range of nonpharmacotherapy services
(match between patients and services)
• Clinicians and Healthcare Systems:• Understanding what it takes to connect patients to broader range of
evidence-based pain services
November 5, 2017
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Learn More
• www.pcori.org
• #PCORI2017
November 5, 2017
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Questions?
November 5, 2017
ANNUAL MEETING | #PCORI2017
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Thank You!Lynn DeBar, PhD, MPHSenior Scientific Investigator, Kaiser Permanente Washington Health Research Institute
November 1, 2017
ANNUALMEETING
OCT. 31-NOV. 2ARLINGTON, VA
#PCORI2017
Behavioral Therapies to Improve Health and Safety of Patients with Opioid-Treated Chronic Pain
Aleksandra Zgierska, MD PhDUniversity of Wisconsin-MadisonDepartment of Family Medicine & Community HealthNovember 1, 2017, PCORI 2017 Annual Meeting
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Aleksandra Zgierska, MD PhD
Has nothing to disclose.
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ObjectivesAt the conclusion of this activity, participants should be able to:• Identify the existing evidence gaps related to the use of
mindfulness meditation (MM) and cognitive behavioral therapy (CBT) for chronic pain.
• Outline the ongoing study aimed to assess the impact of MM and CBT as treatments for severe opioid-treated chronic low back pain.
• Describe the potential impact of the study on practice.
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Pain Care
WikiCommons
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WikiCommons, Ajifo A: Synapse in Brain.
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MM and CBT offer different skills for pain coping and management of chronic pain.
Mindfulness Meditation (MM)Nonjudgmental, accepting awareness of present-moment experiences to change one’s relationship
with these experiences
Cognitive Behavior Therapy (CBT) Focus on modifying unhealthy thoughts, emotions
and behaviors to change the experience and control symptoms.
Creative Commons, Spirit-Fire: Meditation
Wiki Commons, Hokusai: The Great Wave off Kanagawa
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Strategies To Assist with Management of Pain: STAMP Study
Stakeholder-driven evolution of the STAMP study title• PCORI title: “Managing Long-Term Low Back Pain to Improve
Health and Reduce Reliance on Opioid Medicines: Comparing Mindfulness Meditation and Cognitive Behavioral Therapy.”
• Initial title: “A Comparative Effectiveness Randomized Controlled Trial of Mindfulness Meditation versus Cognitive Behavioral Therapy for Opioid-Treated Chronic Low Back Pain.”
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Madison, WIBoston, MA
Salt Lake, UT
Multicenter randomized controlled trial (Principal Investigator: A. Zgierska, University of Wisconsin)
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Patients with chronic low back pain (CLBP) treated with daily opioids
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766 patients with opioid-treated CLBP
Mindfulness meditation (MM)
Cognitive behavior therapy (CBT)
eight weekly two-hour sessions; daily home practice
Patient-reported outcomes at 12 months:↓ pain, ↑ function, ↑ quality of life,
↓ pain medication use
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STAMP Study
Patient/stakeholder-led approach
Sound science/methods
Answers to questions that matterto patients and clinicians
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STAMP Study: Clinical Implications• Guide clinical decision making: patients and clinicians
• Is it effective for opioid-treated CLBP?• Which specific patient groups is it most effective for?
• Those with worse mental health or medication misuse?
• Guide coverage decisions by health plans• Evidence-based treatments are more likely to gain coverage
• Promote the holistic approach to health• Integration of “mind” and “body” treatments
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Wiki Commons, Mount Everest
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Learn More
www.fammed.wisc.edu/STAMPstudy
#PCORI2017
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Questions?
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Thank You!
Aleksandra Zgierska, MD PhDAssistant Professor, University of Wisconsin-Madison
11-1-2017