Treatment Options for Back Pain

Ad Hoc Workgroup Meeting March 21, 2013

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Welcome and Introductions

8:30 AM–9:00 AM

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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

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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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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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

Background on PCORI and the Ad Hoc Workgroups

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David Hickam, MD, MPH Program Director Assessment of Prevention, Diagnosis, and Treatment Options PCORI

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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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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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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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

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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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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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.

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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Setting the Stage

9:00 AM–9:15 AM

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Paul Shekelle, MD, PhD, MPH

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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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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:!

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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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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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%

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%

The Prevalence of Back Pain Continues to Increase

JAMA. 2008;299(6):656-664. doi:10.1001/jama.299.6.656 25

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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Patient Stories

9:15 AM–9:30 AM

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Roundtable Discussion

9:30 AM–11:45 AM

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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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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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Lunch

12:00 PM–12:45 PM

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Identification and Prioritization of Key Research Questions

12:45 PM–3:15 PM

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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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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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Recap and Next Steps

3:15 PM–3:30 PM

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Adjourn 3:30 PM

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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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Connect with PCORI

www.pcori.org

“PCORINews”

@PCORI

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Thank You for Your Participation

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