Slide presentation from the Ad hoc Workgroup Meeting held March 21, 2013.

1. Treatment Options for
Back Pain
Ad Hoc Workgroup Meeting
March 21, 2013
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2. Welcome and Introductions
8:30 AM–9:00 AM
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3. Welcome
David Hickam, MD, MPH
Program Director
Assessment of Prevention, Diagnosis, and
Treatment Options
PCORI
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Joe V. Selby, MD, MPH
Executive Director
PCORI

4. Housekeeping: Providing Input
! Today’s webinar participants can provide input via e-mail
(backpain@pcori.org); via Twitter (using #PCORI); the webinar “chat”
feature; through our web page “Submit a Question on our Targeted
Topics for Research Funding”; and, during the upcoming public comment
period, by telephone.
! Please submit questions today as they occur to you. We will collect and
synthesize these for discussion in the afternoon.
! If you want to comment by phone, we will open the lines during the
comment period at 11:45 AM ET and provide instructions at that time.
! We welcome additional input through 5:00 PM ET April 4 via the web
page “Submit a Question on our Targeted Topics for Research Funding”
and e-mail (backpain@pcori.org).
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5. Introductions: Chair and Moderator
Paul Shekelle, MD, PhD, MPH
Chief of General Medicine, VA Greater Los
Angeles Healthcare System; Director, Southern
California Evidence-Based Practice Center Site,
RAND; Director, Quality Assessment and
Improvement Program, RAND; Professor of
Medicine, UCLA School of Medicine
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6. Introductions: Stakeholders
! Steven J. Atlas, MD, MPH
! Amy Barron, RN
! M. Soledad Cepeda, MD, PhD
! Daniel C. Cherkin, PhD
! Shari Davidson
! Cortney Forward, PhD, MBA
! Julie Fritz, PhD
! Kendi Hensel, DO, PhD
! Gwenn Herman, LCSW-C,
DCSW
! Andrew A. Guccione, PhD
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! Jeffrey G. Jarvik, MD, MPH
! Janet R. Kahn, PhD, LMT
! Partap Khalsa, DC, PhD,
DABCO
! Barbara L. Kornblau, JD, OTR,
FAOTA, DMASPE, CCM, CPE,
CDMS
! Matthew J. McGirt, MD
! Casey Quinlan
! John Triano, DC, PhD, MA,
FCCSC
! Joseph Weistroffer, MD

7. Background on PCORI and the
Ad Hoc Workgroups
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8. 8
David Hickam, MD, MPH
Program Director
Assessment of Prevention,
Diagnosis, and Treatment Options
PCORI

9. About PCORI
! An independent non-profit research
organization authorized by Congress as part
of the 2010 Patient Protection and Affordable
Care Act (ACA)
! Committed to continuously seeking input from
patients and a broad range of stakeholders to
guide its work
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10. PCORI’s Mission and Vision
Mission
The Patient-Centered Outcomes Research Institute (PCORI)
helps people make informed healthcare decisions and
improves 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.
Vision
Patients and the public have the information they need to
make decisions that reflect their desired health outcomes.
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11. PCORI’s First Targeted Research Topics
! Identified five high-priority,
stakeholder-vetted topics
! Jumpstarts PCORI’s long-
term topic generation and
research prioritization effort
! Builds on similar, earlier
efforts by others
! Allows us to build on our
engagement work
Treatment Options for Uterine
Fibroids
Treatment Options for Severe Asthma
in African Americans and Hispanics/
Latinos
Preventing Injuries from Falls in the
Elderly
Treatment Options for Back Pain
Obesity Treatment Options in Diverse
Populations
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12. Targeted PFA Workgroup Goals
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Confirm the importance and timeliness
of particular research topics
Understand the potential for research
to lead to rapid improvement in
practice, decision making, and
outcomes
Identify high-impact research questions
that will result in findings that are likely
to endure and are not currently studied
Obtain input from researchers,
patients, and other stakeholders
Provide summary
of findings to
Board of
Governors
Seek consensus on identified
knowledge gaps and specific
questions within those topics

13. Workgroup Objectives: A Narrowing
Process
! Consider the broad range of research
questions provided by researchers,
patients, and other stakeholders
! Narrow questions to determine which are
most critical
! Narrow further by identifying a concise list
of high-priority questions
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14. Criteria for Knowledge and Research Gaps
Knowledge and research gaps should:
 Be patient-centered: Is the proposed knowledge gap of specific
interest to patients, their caregivers, and clinicians?
 Assess current options: What current guidance is available on the
topic, and is there ongoing research? How does this help determine
whether further research is valuable?
 Have potential to improve care and patient-centered outcomes:
Would new knowledge generated by research be likely to have an
impact in practice?
 Provide knowledge that is durable: Would new knowledge on this
topic remain current for several years, or would it be rendered
obsolete quickly by subsequent studies?
 Compare among options: Which of two or more options lead to
better outcomes for particular groups of patients?
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15. How PCORI Gathers Input
! Researchers, patients, and stakeholders who have been invited
to this workgroup give input during the workgroup.
! The broad community of researchers, patients, and other
stakeholders can give input via our website—for the past four
weeks and for the next two.
! Webinar participants can provide input via e-mail
(backpain@pcori.org); Twitter (#PCORI); the webinar “chat”
feature; the “Submit a Question on our Targeted Topics” web
page; and, during the upcoming public comment period, by
phone.
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PCORI distinguishes “input” to the PFA development process from
“involvement” in the process.
Input is information that may or may not be considered or used in crafting
the PFA. Involvement is the activity of determining what will be in the PFA.

16. How PCORI Manages the Potential for
Conflict of Interest
! Participants in this workgroup will be eligible to apply for funding if
PCORI decides to produce a funding announcement in studying
treatment options for back pain.
! The Chair of this workgroup will not be eligible.
! Input received during the workgroup deliberations is broadcast via
webinar, and the webinar is then archived and available to other
researchers, patients, or stakeholders on the website.
! PCORI does not have subsequent discussions with the presenters after
this workgroup.
! Presenters have been explicitly instructed and are expected to address
a set of questions we have asked—not to tell us about their research.
! There should be no “influence advantage” to being a workgroup
member, nor any knowledge advantage as to what will eventually be
requested in the PFA.
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17. Setting the Stage
9:00 AM–9:15 AM
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18. Paul Shekelle, MD, PhD,
MPH
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19. Low Back Pain
! Affects a lot of people
 Second most common symptom for adult office visits
! Is of uncertain origin in most patients
 Only about 15% of acute exacerbations have anatomic or
physiologic causes (e.g., herniated disc, lumbar spinal
stenosis)
for which there is widespread agreement on diagnostic
criteria
! Has a variable but mostly favorable natural history for acute
exacerbations
 About 70% of patients return to usual activities in four weeks
 However, about 10% develop persistent disabling pain
! Costs a lot of money
 One estimate is $80+ billion in annual direct expenditures
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20. Date of download: 3/14/2013!
Copyright © 2012 American Medical Association.
All rights reserved.!
From: Expenditures and Health Status Among Adults With Back and Neck Problems!
JAMA. 2008;299(6):656-664. doi:10.1001/jama.299.6.656!
Adults presented with self-reported back and neck problems, referred to as “spine problems” based on Medical Expenditure Panel
Survey (MEPS) descriptions and International Classification of Diseases, Ninth Revision, Clinical Modification definitions.
Expenditures for all years were converted to 2005 equivalents using the Consumer Price Index medical component. Error bars
indicate 95% confidence intervals.!
Figure Legend:!

21. Development of Persistent Disabling
Low Back Pain
! The factors most associated with development of
persistent disabling low back pain are not anatomic
or physiologic causes of back pain
 Maladaptive coping behaviors
 Presence of psychiatric comorbidities
 Low general health status
 High baseline functional impairment
Taken from Chou R, Shekelle P. Will this patient develop persistent disabling low
back pain? JAMA. 2010;303:1295-302.
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22. Treatments for Low Back Pain
! There is a plethora of treatments and providers for
back pain
! Often there is a tight linkage between the provider
type and the treatment:
• Primary care MD – NSAIDs, muscle relaxants
• Physical therapist – exercise, ultrasound
• Chiropractor – spinal adjustments/manipulation
• Physical medicine – epidural injections
• Surgeons – surgery
• Acupuncturist – acupuncture
! A consequence of this has been to introduce “tunnel
vision” into decision making for low back pain patients
.
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23. Growth in Medicare-Allowed Charges for Ten Selected
High-Growth Service Categories (2000–2006)
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Cardiac defibrillator implantation to prevent sudden death 165%
Cardiac stress testing for coronary artery disease 123%
CT/MRI scans: brain 56%
CT/MRI scans: lumbar/spine 96%
Diagnosis and medication therapy for macular degeneration 225%
Electro diagnostic testing for nerve problems 256%
Mohs surgery for skin cancer 154%
Polysomnography for sleep apnea 422%
Procedures for benign prostatic hyperplasia 1,991%
Spinal injection procedures for back pain 731%

24. Growth in Medicare-Allowed Charges for Ten Selected
High-Growth Service Categories (2000–2006)
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Cardiac defibrillator implantation to prevent sudden death 165%
Cardiac stress testing for coronary artery disease 123%
CT/MRI scans: brain 56%
CT/MRI scans: lumbar/spine 96%
Diagnosis and medication therapy for macular degeneration 225%
Electro diagnostic testing for nerve problems 256%
Mohs surgery for skin cancer 154%
Polysomnography for sleep apnea 422%
Procedures for benign prostatic hyperplasia 1,991%
Spinal injection procedures for back pain 731%

25. The Prevalence of Back Pain
Continues to Increase
JAMA. 2008;299(6):656-664. doi:10.1001/jama.299.6.656
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26. Discussion: Some Questions to Get Started
! What can be done to prevent the development
of chronic low back pain?
! Will a better way of classifying patients (other
than the acute–sub acute–chronic paradigm)
result in being better able to identify treatments
appropriate for certain patient groups?
! What are the benefits and harms of the
increased use of advanced imaging in patients
with back pain in terms of improved outcomes
with back pain treatments?
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27. Patient Stories
9:15 AM–9:30 AM
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28. Roundtable Discussion
9:30 AM–11:45 AM
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29. Key Themes
! Methods for Classifying Patients for Treatment
Planning
! Effectiveness of Treatment Options
! Relapse Prevention and Self-Management
! Prioritizing Outcomes
! Healthcare Systems
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30. Public Comments
11:45 AM–12:00 PM
The phone line is now open for your comments.
You can also comment via e-mail
(backpain@pcori.org); via Twitter (#PCORI); or
through the webinar “chat” feature.
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31. Lunch
12:00 PM–12:45 PM
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32. Identification and Prioritization of
Key Research Questions
12:45 PM–3:15 PM
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33. Criteria for Knowledge and Research Gaps
! Knowledge and research gaps should:
 Be patient-centered: Is the proposed knowledge gap of specific
interest to patients, their caregivers, and clinicians?
 Assess current options: What current guidance is available on the
topic, and is there ongoing research? How does this help determine
whether further research is valuable?
 Have potential to improve care and patient-centered outcomes:
Would new knowledge generated by research be likely to have an
impact in practice?
 Provide knowledge that is durable: Would new knowledge on this
topic remain current for several years, or would it be rendered
obsolete quickly by subsequent studies?
 Compare among options: Which of two or more options lead to
better outcomes for particular groups of patients?
33

34. Key Themes - Revisited
! Methods for Classifying Patients for Treatment Planning
! Effectiveness of Treatment Options
! Relapse Prevention and Self-Management
! Prioritizing Outcomes
! Healthcare Systems
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35. Recap and Next Steps
3:15 PM–3:30 PM
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36. Adjourn
3:30 PM
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37. We Still Want to Hear from You
! We welcome your input on today’s discussion
! We are accepting comments and questions for
consideration on this topic through 5:00 PM ET on
Thursday, April 4, via:
 E-mail (backpain@pcori.org)
 Our “Submit a Question on our Targeted Topics for
Research Funding” web page
! We will take all feedback into consideration
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38. Connect with PCORI
www.pcori.org
“PCORINews”
@PCORI
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39. Thank You for Your
Participation
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