Selecting Outcome Metrics for Your Outpatient Practice: An ICF-Based Approach Presenters: David Berbrayer, MD, Amy Houtrow, MD, PhD, MPH; Armando Miciano, MD; M. Elizabeth Sandel, MD (Director); Deepthi Saxena, MD 2014 AAPMR Annual Assembly, San Diego CA, 2014 Nov 15

Selecting Outcome Metrics for Your Outpatient Practice: An ICF-Based Approach Learning objectives: 
1. Define foundational concepts of the ICF that serve as a guide for the choice of PM&R outcome metrics 
2. Understand variety of resources available for selection of outcome metrics for PM&R patient populations 
3. Incorporate outcome measurement into outpatient practices for a variety of patient populations to enhance physiatric care using core sets of measures

Outcome Core Set – Chronic Low Back Pain Section Presenter: Armando Miciano, MD Nevada Rehabilitation Institute Las Vegas, NV 2014 AAPMR Annual Assembly, San Diego CA, 2014 Nov 15

Disclosures Medical Director Spring Mountain Rehab, Las Vegas NV Practitioner – Nevada Rehabilitation Institute, Las Vegas NV

Acknowledgments – CLBP QTB Subject Matter Experts: 1. David Berbrayer MD (Performance Metrics Committee member) 2. Edwin Capulong MD 3. Kush Goyal MD 4. Martin Grabois MD (Co-leader) 5. Armando Miciano MD (Clinical Practice Guideline Committee member) 6. Joshua Scheidler MD 7. Deborah Venesy MD (Co-leader)

INTRODUCTION Most common assessment: Evaluation of underlying impairment & pathology Specialists performing evaluations for MSK disorders will be best served when they can: Assess the individual's functional status Incorporate that information into their decision regarding the individual's current limitations and prognosis In addition to the evaluation of the underlying impairment and pathology. [1] [1] Greenough CG. Eur Spine J. 2006.

Functional Status Many of the factors contributing to the evaluation of functional status are necessarily subjective e.g. pain, physical functioning, and affective status Nonetheless, the literature suggests that inclusion of functional assessment into the [MSK] disability determination using a patient-centered approach may provide the factors that are most potent with respect to patient prognosis and care planning. [1] [1] Linn RT, Granger CV, et al. Phys Med Rehabil Clin N Am. 2001.

How should clinicians measure “Patient-centered Outcomes How should clinicians measure “Patient-centered Outcomes?” INTRODUCTION – Performance Metrics DEFINITION: The field of developing, evaluating & applying measurement instruments Undergone considerable progress in MSK medicine [1]. [1] Mooney V, et al. Spine J. 2010 May;10(5):433-40.

INTRODUCTION – Progress in Performance Metrics How is recovery from low back pain measured? A systematic review of the literature BACKGROUND: No accepted definition of what recovery involves or guidance as to how it should be measured. OBJECTIVE: To appraise the LBP literature (last 10 years) to review the methods used to measure recovery. RESEARCH DESIGN: All prospective studies of subjects with non-specific LBP that measured recovery as an outcome Kamper SJ, et al. Eur Spine J. 2011.

INTRODUCTION – Progress in Performance Metrics How is recovery from low back pain measured? A systematic review of the literature RESULTS: 82 included studies used 66 different measures of recovery 17 measures used pain as a proxy for recovery, 7 used disability or function 17 based on a combination of two or more constructs. 9 single-item recovery rating scales 11 studies used a global change scale that included an anchor of ‘completely recovered’ 3 measures used return to work as the recovery criterion 2 used time to insurance claim closure 7 used physical performance Kamper SJ, et al. Eur Spine J. 2011.

INTRODUCTION – Which PRO to use? How is recovery from low back pain measured? A systematic review of the literature CONCLUSIONS: Almost every study that measured recovery from LBP in the last 10 years did so differently Lack of consistency makes interpretation & comparison of the LBP literature problematic. That the failure to use a standardized measure of recovery is due to the absence of an established definition “Absence of established definition” >>> soln: ICF Kamper SJ, et al. Eur Spine J. 2011.

Another Challenge Despite progress in PERFORMANCE METRICS, the appreciation of the complex interrelationship between: Physical Psychological Social effects of MSK disorders is incompletely explored in clinical practice. [1] [1] Mayer T, et al. Spine J. 2003 May-Jun;3(3 Suppl):28S-36S. Review.

LEARNING KEY POINT * THE ICF Model The WHO then replaced the ICIDH with the ICF to be more comprehensive, recognizing three key components of disablement: body functions and body structures, activity, and participation. Body functions and body structures are “physiological functions and body parts respectively.” Activity is “the execution of a task by an individual (typically within their personal sphere).” Finally, participation is “involvement in life situation (typically within a social sphere) International Classification of Functioning, Disabilities, and Health: ICF. 2001. Source: World Health Organization (2001) International Classification of Functioning, Disability and Health (ICF), Geneva: World Health Organization.

Activity limitations: Impairments: problems in body function or structure such as significant deviation or loss Activity limitations: difficulties an individual may have in executing activities. Participation restrictions: problems an individual may experience in involvement in life situations. How do literature reports apply the ICF ??? Rondelli, RD.  PM&R. 2009.

Tools in the Quality Toolbox (QTB) Review articles Knowledge Now articles Clinical practice guidelines Core constructs specific for the health condition Assessment instruments Quality metrics Patient education materials Checklists

QTB: Review Articles 1. Chapman JR, Norvell DC, et al. Evaluating common outcomes for measuring treatment success for chronic low back pain. Spine (Phila Pa 1976). 2011 Oct 1; 36(21 Suppl):S54-68. 2. Cleland J, Gillani R, Bienen EJ, Sadosky A. Assessing dimensionality and responsiveness of outcomes measures for patients with low back pain. Pain Pract. 2011 Jan-Feb; 11(1):57-69. 3. DeVine J, Norvell DC, et al. Evaluating the correlation and responsiveness of patient-reported pain with function and quality-of-life outcomes after spine surgery. Spine (Phila Pa 1976). 2011 Oct 1;36(21 Suppl):S69-74. 4. Deyo RA, Dworkin SF, et al. Report of the NIH Task Force on research standards for chronic low back pain. Pain Med. 2014 Aug; 15(8):1249-67. 5. Freiberger E, et al. Performance-based physical function in older community-dwelling persons: a systematic review of instruments. Age Ageing 2012; 41: 712–721. 6. Ghogawala Z, Resnick DK, et al. Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 2: assessment of functional outcome following lumbar fusion. J Neurosurg Spine. 2014 Jul; 21(1):7-13. 7. McCormick JD1, Werner BC, Shimer AL. Patient-reported outcome measures in spine surgery. J Am Acad Orthop Surg. 2013 Feb;21(2):99-107. 8. Schoenfeld AJ, Bono CM. Measuring spine fracture outcomes: common scales and checklists. Injury. 2011 Mar;42(3):265-70.

QTB: Review Articles Outcome Measures Considerations Chapman JR, et al. Spine. 2011 VAS, NRPS ODI, RMDQ. SF-36 EQ-5D or SF-6D. Psychosocial tests validity, reliability, & responsiveness to change Cleland J, et al. Pain Pract. 2011 Roland Morris Disability Questionnaire, Oswestry Disability Index the most comprehensively validated measures with respect to responsiveness. DeVine J, et al. VAS ODI SF-12, EQ-5D Strength of rec: strong Deyo RA, et al. Pain Med. 2014 PROMIS A Report of the NIH Task Force (Expert Panel)

QTB: Review Articles, contd. Outcome Measures Considerations Freiberger E, et al. Age Ageing 2012 Short Physical Performance Battery Physical Performance Test Continuous Scale Physical Functional Performance. validity, reliability and responsiveness, Ghogawala Z, et al. J Neurosurg Spine. 2014 ODI SF-36 and the SF-12 For fusion cases McCormick JD, et al. J Am Acad Orthop Surg. 2013 VAS-back, VAS-leg ODI, RMDQ EQ-5D, SF ODI & RMDQ with established MCID Schoenfeld AJ, et al. Injury. 2011 VAS SF-36

Key Psychometric Properties of a Health Status Instrument Measurement Property Description Validity The measure quantifies what it is intended to (face validity), represents all important content of the construct (content validity), and is empirically demonstrated to be associated with the construct it was designed to measure (criterion validity) Reliability Reproducible results are obtained when the measure is repeatedly given to stable patients Responsiveness The measure is sensitive to clinical change Interpretable A clinical framework is available to interpret cross-sectional and longitudinal changes in scores Translations exist Linguistically and culturally appropriate translations are available so that multiple patients, from different countries and cultures, can be pooled for analysis Spertus JA. Circulation. 2008.

COSMIN taxonomy of relationships of measurement properties Adapted from: Mokkink LB, et al. Qual Life Res. May 2010; 19(4): 539–549.

QTB: PMR Knowledge NOW * Carayannopoulos A. Discogenic Lumbar Pain. In: PMR Knowledge NOW [Internet]. 2011 Nov 10 [modified 2013 Jan 24]. c2014 AAPMR. Accessed 10/22/14 at: http://me.aapmr.org/kn/article.html?id=176 Everett CR, Ramirez C, Perkowski M. Lumbar Disc disorders. In: PMR Knowledge NOW [Internet]. 2013 Sep 20. c2014 AAPMR. Accessed 10/22/14 at: http://me.aapmr.org/kn/article.html?id=133 Nance PW, Chen H. Lumbar stenosis. In: PMR Knowledge NOW [Internet]. 2012 Jul 20 [modified 2013 Jan 23]. c2014 AAPMR. Accessed 10/22/14 at: http://me.aapmr.org/kn/article.html?id=137 Spires MC. Inflammatory Arthritides. In: PMR Knowledge NOW [Internet]. 2011 Nov 10 [modified 2012 Dec 27]. c2014 AAPMR. Accessed 10/22/14 at: http://me.aapmr.org/kn/article.html?id=82 * Selected ones with discussion on Functional Assessment tools

QTB: Clinical Practice Guidelines North American Spine Society (NASS). Clinical Guidelines for Multidisciplinary Spine Care Diagnosis and Treatment of Lumbar Disc Herniation with Radiculopathy. c2012 NASS. Accessed 10/22/14 at: https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/Lumba rDiscHerniation.pdf North American Spine Society (NASS). Clinical Guidelines for Multidisciplinary Spine Care Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis. c2011 NASS. Accessed 10/22/14 at: https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/Lumba rStenosis.pdf North American Spine Society (NASS). Clinical Guidelines for Multidisciplinary Spine Care Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis. c2008 NASS. Accessed 10/22/14 at: https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/Spond ylolisthesis.pdf American Academy of Orthopedic Surgeons (AAOS). Treatment of Symptomatic Osteoporotic Spinal Compression Fractures. 2010. Accessed 10/22/14 at: http://www.aaos.org/research/guidelines/SCFguideline.pdf

QTB: Clinical Practice Guidelines NASS: Lumbar Disc Herniation w/ Radiculopathy Spinal Stenosis Spondylolisthesis AAOS: Compression FX “Refer to a publication entitled Compendium of Outcome Instruments for Assessment and Research of Spinal Disorders. “Refer to a publication entitled Compendium of Outcome Instruments for Assessment and Research of Spinal Disorders.” The Zurich Claudication Questionnaire (ZCQ)/Swiss Spinal Stenosis Questionnaire (SSS), Oswestry Disability Index (ODI), Likert Five-Point Pain Scale 36-Item Short Form Health Survey (SF-36) Pain – VAS (0-100) Pain – NRS (0-10) Oswestry Disability Index Roland-Morris Disability Questionnaire SF-36 Physical Component Summary AQoL EQ-5D

Constructs for core sets (for choice of assessment instruments) 1. Symptom quality 2. Pain-related impairment 3. Life satisfaction 4. Global health status 5. Work productivity [1] Bombardier C. Spine (Phila Pa 1976). 2000.

QTB: Assessment Instruments PRO vs. PBA = Patient-Reported Outcomes – from the “patient” PBA = Performance Based Assessment - medical search term used also as outcome measures - clinician-derived objective tests

Patient-Reported Outcomes (PRO) ICF component 1: body function/structure a. Numerical Rating Scale (NRS) – body pain b. NRS – leg pain ICF component 2: activity a. Generic: 1. Pain Disability Questionnaire (PDQ) b. Disease-specific: 1. Oswestry Disability Index (ODI) 2. Roland Morris Disability Questionnaire (RMDQ) ICF component 3: participation a. PROMIS-57 v1.0 i. PROMIS-57 Physical function subscale ii. PROMIS-57 Pain Impact b. Work Productivity & Activity Impairment: General Health (WPAI: GH) v2.0

Performance-based Assessment (PBA) a. ICF component 1: body function/structure i. Lumbar Range of motion test ii. Backache Index (BAI) b. ICF component 2: activity i. 6-Minute Walk Test c. ICF component 3: participation i. Short Physical Performance Battery

Body Functions & Structures ICF Conceptual Framework: Outcome Measures used in Practice– Chronic Low Back Pain Body Functions & Structures PRO: NRS – body pain; NRS – leg pain Activity Generic: PDQ; Disease-specific: ODI, RMDQ Participation PROMIS-57 WPAI:GH PRO and PBA used in my practice setting

ICF Conceptual Framework: Outcome Measures - Low Back Dysfunction Body Functions & Structures PBA: Lumbar ROM Backache Index Activity 6-Minute Walk Test Participation Short Physical Performance Battery PRO and PBA used in my practice setting

Constructs for Core Sets (for choice of assessment instruments) Symptom quality Pain-related Impairment Life Satisfaction Global Health Status Work Productivity Numerical Rating Scale (NRS) – body pain b. NRS – leg pain Generic: Pain Disability Questionnaire Disease-specific: Oswestry Disability Index; ii. Roland Morris Disability Questionnaire PROMIS-57 - Satisfaction with Social Role PROMIS-57 Physical Function PROMIS-57 Pain Impact Work Productivity & Activity Impairment: General Health (WPAI: GH)

Minimal clinically important improvement (MCII) Definition: the smallest clinical change that is important to patients, and recognizes the fact that there are some treatment-induced statistically significant improvements that are too small to matter to patients. Also as Minimal clinical important difference (MCID) Accessed 05/25/14 at: http://www.aaos.org/research/guidelines/SCFguideline.pdf

MCII Pain – VAS (0-100) 15 Pain – NRS (0-10) 2 Outcome Measures MCII (points) Pain – VAS (0-100) 15 Pain – NRS (0-10) 2 Oswestry Disability Index 10 Roland-Morris Disability Questionnaire 5 PROMIS-57 Not reported WPAI: GH Accessed 10/23/14 at: http://www.aaos.org/research/guidelines/SCFguideline.pdf

QTB: Quality Metrics To qualify for the 2014 PQRS incentive payment, Physiatrists must report on at least 9 individual measures covering 3 National Quality Strategy (NQS) domains for at least 50 percent of your Medicare Part B FFS patients seen during the reporting period. Alternatively, you can report at least 1 measures group on a 20-patient sample, a majority of which (at least 11 out of 20) must be Medicare Part B FFS patients. Accessed 10/23/14 at: http://www.aapmr.org/research/PQRS/Pages/default.aspx

QTB: Quality Metrics I. Measure Group 1. PQRS # 148-151, Back Pain Measures Group II. Individual Measures 1. Patient Safety domain: a. PQRS #130, Documentation of Current Medications in the Medical Record b. PQRS #154, Falls: Risk Assessment 2. Communication and Care Coordination domain: a. PQRS #182, Functional Outcome Assessment b. PQRS #131, Pain Assessment and Follow-Up c. PQRS #155, Falls: Plan of Care d. PQRS #24, Osteoporosis: Communication with the Physician Managing On- going Care Post-Fracture of Hip, Spine or Distal Radius for Men and Women Aged 50 Years and Older e. PQRS #47, Advance Care Plan 3. Clinical Process and Effectiveness domain: a. PQRS #39, Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older b. PQRS #40, Osteoporosis: Management Following Fracture of Hip, Spine or Distal Radius for Men and Women Aged 50 Years and Older c. PQRS #41, Osteoporosis: Pharmacologic Therapy for Men and Women Aged 50 Years and Older 4. Population Health domain: a. PQRS #128, Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up b. PQRS #134, Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan Accessed 10/23/14 at: http://www.aapmr.org/research/PQRS/Pages/default.aspx

QTB: Quality Metrics I. Measure Group 1. PQRS # 148-151, Back Pain Measures Group II. Individual Measures 1. Patient Safety domain: a. PQRS #130, b. PQRS #154, 2. Communication and Care Coordination domain: a. PQRS #182, b. PQRS #131, c. PQRS #155, d. PQRS #24, e. PQRS #47, 3. Clinical Process and Effectiveness domain: a. PQRS #39, b. PQRS #40, c. PQRS #41, 4. Population Health domain: a. PQRS #128, b. PQRS #134 Accessed 10/23/14 at: http://www.aapmr.org/research/PQRS/Pages/default.aspx

What we learned today: Learning objectives: 
1. Define foundational concepts of the ICF that serve as a guide for the choice of PM&R outcome metrics 
2. Understand variety of resources available for selection of outcome metrics for PM&R patient populations 
3. Incorporate outcome measurement into outpatient practices for a variety of patient populations to enhance physiatric care using core sets of measures

Constructs for Core Sets (for choice of assessment instruments) Symptom quality Pain-related Impairment Life Satisfaction Global Health Status Work Productivity Numerical Rating Scale (NRS) – body pain b. NRS – leg pain Generic: Pain Disability Questionnaire Disease-specific: Oswestry Disability Index; Roland Morris Disability Questionnaire PROMIS-57 - Satisfaction with Social Role PROMIS-57 Physical Function PROMIS-57 Pain Impact Work Productivity & Activity Interference: General Health (WPAI: GH)

Summary: Recommended PRO for practical use Numerical Rating Scale (NRS) – body pain; and, NRS – leg pain Pain Disability Questionnaire (PDQ) Oswestry Disability Index (ODI) or Roland-Morris Disability Questionnaire (RMDQ) PROMIS-57 v1.0 Work Productivity & Activity Impairment: General Health (WPAI: GH) v2.0

Nevada Rehabilitation Institute, Las Vegas NV Thank You. Contact Info: Armando Miciano, M.D. Nevada Rehabilitation Institute, Las Vegas NV www.springmountainrehab.com 702-869-4401 drmiciano@me.com