Monitoring Criteria: The Role of

Patient-Reported Outcomes in CLBP.

Armando Miciano, M.D.Nevada Rehabilitation Institute, Las Vegas NV2014 AAPMR Annual Assembly, San Diego CA,

2014 Nov 14

1. Understand the steps in determination of outcome measures of interest

2. Determine the applicability of the CPG by its:• identification of criteria to assess guideline

implementation or adherence to recommendations

• criteria for assessing impact of implementing the recommendations

• advice on the frequency and interval of measurement

• descriptions or operational definitions of how the criteria should be measured

Course section – Learning Objectives

Process measures, which assess the extent to which physicians effectively implement clinical practices (or treatments) that have been shown to result in high-quality or efficient care. ◦ e.g. PQRS measure #148-151, LBP measure group

Outcome measures, which track the results of physician care, such as mortality, infections, and how patients experience that care.◦ e.g. Patient-reported outcomes (PRO)◦ e.g. Performance-based assessment (PBA)

Glossary: Performance Measures

GAO. Clinical Data Registries. 2013. Accessed 10/20/14 at: http://www.gao.gov/assets/660/659701.pdf

PRO = Patient-Reported Outcomes – from the “patient”

PBA = Performance Based Assessment medical search term used also as outcome

measures clinician-derived objective tests

PRO vs. PBA

ENDORSED BY AAPMR: Diagnosis and Treatment of Degenerative Spondylolisthesis

◦ developed by the North American Spine Society (NASS). Diagnosis and Treatment of Degenerative Lumbar Spinal

Stenosis ◦ developed by NASS.

Treatment of Symptomatic Osteoporotic Spinal Compression Fractures◦ developed by the American Academy of Orthopaedic Surgeons (AAOS)

AFFIRMED BY AAPMR: Low back pain: clinical practice guidelines linked to the

International Classification of Functioning, Disability, and Health◦ developed by the Orthopaedic Section of the American Physical Therapy

Association.

LBP CPG available via AAPMR website links

Accessed 10/20/14 at: http://www.aapmr.org/research/practice-guidelines/Pages/Applicable-PMR-Guidelines.aspx

Ghogawala Z, 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.

North American Spine Society. Diagnosis and treatment of lumbar disc herniation with radiculopathy. Burr Ridge (IL): North American Spine Society; 2012. 100 p.

“Other CLBP CPG”

Spondylolisthesis

Spinal Stenosis

Compression Fx

APTA LBP CPG

Reviewed by a groupexperienced in performance measure developmentto identify those recommendationsrigorous enough for measure development.

All relevant medical specialties involved inthe guideline development and at the Consortiumwill be invited to collaborate in the developmentof evidence-based performance measures related tospine care.

Reviewed by a group experienced in performance measure development to identify thoserecommendations rigorous enough for measure development.

All relevant medical specialties involved in the guideline developmentand at the Consortium will be invited to collaborate inthe development of evidence-based performance measures related to spine care.

Patient-oriented outcomes are included wherever possible.

If patient-oriented outcomes were not available surrogate/intermediate outcomes were considered. Surrogate outcome measures are laboratory measurements or another physical sign used as substitutes for a clinically meaningful end point that measures directly how a patient feels, functions, or survives. Radiographic results are an example of a surrogate outcome.

The results using validated instruments are considered the best available evidence. All outcomes we reported were validated in a spine patient population.

Not provided

Identification and Development ofPerformance Measures

GRADE A recommendation

GRADE B rec. INSUFFICIENT EVIDENCE

•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)

•The Japanese Orthopedic Association (JOA) Score

•the calculated Recovery Rate

•The Shuttle Walking Test (SWT),

•Oxford Claudication Score (OCS),

• Low Back Pain Bothersome Index •Stenosis Bothersome Index

What are the appropriateoutcome measures for thetreatment of ……SPONDYLOLISTHESIS

“The North American Spine Society has a publication entitled Compendium of Outcome Instruments for Assessment and Research of Spinal Disorders.” To purchase a copy of the Compendium, visit https://webportal.spine.org/Purchase/ProductDetail.aspx?Product_

“For additional information about the

Compendium, please contact the NASS Research Department at nassresearch@spine.org.”

What are the appropriateoutcome measures for thetreatment of ……SPINAL STENOSIS

Accessed 10/20/14 at: https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/LumbarStenosis.pdf

Major Outcomes Considered: Sensitivity and specificity of diagnostic

tests Visual analog scale (VAS) score Quality of life/basic activities of daily living Walking distance Patient satisfaction Postoperative complication rate Age-related outcomes

What are the appropriateoutcome measures for thetreatment of ……SPINAL STENOSIS

Accessed 10/20/14 at: http://www.guideline.gov/content.aspx?id=34839

Clinical studies often report many different outcomes. For this guideline, patient-oriented outcomes are included wherever possible. ◦ If patient-oriented outcomes were not available surrogate/intermediate outcomes

were considered. ◦ Surrogate outcome measures are laboratory measurements or another physical

sign used as substitutes for a clinically meaningful end point that measures directly how a patient feels, functions, or survives.

◦ Radiographic results are an example of a surrogate outcome.

For outcomes measured using “paper and pencil” instruments (e.g. the visual analogue scale), the results using validated instruments are considered the best available evidence. ◦ In the absence of results using validated instruments, results using non-validated

instruments are considered as the best available evidence and the strength of the recommendation is lowered.

For this guideline, all outcomes we reported were validated in a spine patient population.

What are the appropriate outcome measures for the treatment of ……COMPRESSION FRACTURE

Accessed 10/20/14 at: http://www.aaos.org/research/guidelines/SCFguideline.pdf

Considered the effects of treatments in terms of the minimal clinically important improvement (MCII) in addition to whether their effects were statistically significant.

The MCII is the smallest clinical change that is important to patients, ◦ recognizes the fact that there are some treatment-induced

statistically significant improvements that are too small to matter to patients.

The values used for MCIIs are derived from a published study investigating the Visual Analogue Scale, the Numerical Rating Scale, the Oswestry Disability Index, and the Roland Disability Questionnaire; a study investigating the Physical Component Summary of the SF-36; a study investigating the Assessment of Quality of Life instrument (AQoL); and a study investigating the EQ-5D instrument.

MINIMAL CLINICALLY IMPORTANT IMPROVEMENT (MCII)

Accessed 10/20/14 at: http://www.aaos.org/research/guidelines/SCFguideline.pdf

Outcome Measure MCII (points)

Pain – VAS (0-100) 15

Pain – NRS (0-10) 2

Oswestry Disability Index 10

Roland-Morris Disability Questionnaire

5

SF-36 Physical Component Summary

4.9

AQoL 0.06

EQ-5D 0.074

MCII (also as MCID)

Accessed 10/20/14 at: http://www.aaos.org/research/guidelines/SCFguideline.pdf

VAS – Visual Analog Scale; NRS – Numerical Rating Scale; AQOL – Assessment of Quality of Life;

Major Outcomes Considered: Diagnostic accuracy

◦ (sensitivity, specificity, positive and negative likelihood ratios)

Effectiveness of interventions in terms of pain relief, improvement of functioning, quality of life

Pain Perceived disability Back-specific function Mobility Generic health status Patient satisfaction

What are the appropriate outcome measures for the treatment of ……LBP (per APTA)?

Accessed 10/20/14 at: http://www.orthopt.org/uploads/content_files/ICF/Updated_Guidelines/Low_Back_Pain_Clinical_Practice_Guidelines___JOSPT_2012.pdf

EXAMINATION – OUTCOME MEASURES: Clinicians should use validated self-report questionnaires, such as the Oswestry Disability Index and the Roland-Morris Disability Questionnaire. These tools are useful for identifying a patient’s baseline status relative to pain, function, and disability and for monitoring a change in a patient’s status throughout the course of treatment.

(Recommendation based on strong evidence.)

EXAMINATION – ACTIVITY LIMITATION AND PARTICIPATION RESTRICTION MEASURES: Clinicians should routinely assess activity limitation and participation restriction through validated performance-based measures. Changes in the patient’s level of activity limitation and participation restriction should be monitored with these same measures over the course of treatment.

(Recommendation based on expert opinion.)

What are the appropriate outcome measures for the treatment of ……LBP (per APTA)?

Accessed 10/20/14 at: http://www.orthopt.org/uploads/content_files/ICF/Updated_Guidelines/Low_Back_Pain_Clinical_Practice_Guidelines___JOSPT_2012.pdf

Measuring the application of guideline recommendations can facilitate their ongoing use.

This requires clearly defined criteria that are derived

from the key recommendations in the guideline. ◦ The criteria may include

process measures, behavioral measures, clinical or health outcome measures. [1]

Examples of monitoring and audit criteria are: % of

LBP assessed for NRS, functional disability, psychological factors

Weakness – LBP CPG: Presentation of monitoring/auditing criteria.

[1] AGREE Next Steps Consortium (2009). Applicability – Monitoring and/or auditing criteria (no. 21). In: The AGREE II Instrument [Electronic version]. Retrieved 05/18/14, from http://www.agreetrust.org . P. 36

Item content includes the following CRITERIA:

• identification of criteria to assess guideline implementation or adherence to recommendations

• criteria for assessing impact of implementing the recommendations

• advice on the frequency and interval of measurement

• descriptions or operational definitions of how the criteria should be measured [1]

Presentation of monitoring/auditing criteria: How to rate LBP CPG

[1] AGREE Next Steps Consortium (2009). Applicability – Monitoring and/or auditing criteria (no. 21). In: The AGREE II Instrument [Electronic version]. Retrieved 05/18/14, from http://www.agreetrust.org . P. 36

Measure Description – LBP Initial Visit:

Percentage of patients at least 18 years of age and younger than 80 with a diagnosis of back pain who have medical record documentation of all of the following on the date of the initial visit to the physician:

◦ 1. Pain assessment◦ 2. Functional status◦ 3. Patient history, including notation of presence or absence of

“red flags”◦ 4. Assessment of prior treatment and response, and◦ 5. Employment status

Process Measure

National Quality Forum – Measure no. 322: Back Pain Initial Visit. Accessed 05/18/14 at: http://www.aapmr.org/research/performance/pmrmeasures/Pages/Low-Back-Pain-Measures.aspx

Measure Description – LBP Patient Reassessment:

Percentage of patients at least 18 years of age and younger than 80 with back pain with documentation that the physician conducted reassessment of both of the following within four to six weeks of their initial back pain visit or of a surgical procedure date: ◦ 1) Pain AND◦ 2) Functional status

Process Measure

National Quality Forum – Measure no. 306: Back Pain Patient Reassessment. Accessed 05/18/14 at: http://www.aapmr.org/research/performance/pmrmeasures/Pages/Low-Back-Pain-Measures.aspx

Adult acute and subacute low back pain: percentage of patients with low back pain diagnosis who have a reassessment at each follow-up visit that includes: ◦ pain assessment using the Visual Analog Scale,

pain diagram or other assessment tool; ◦ functional status using the Oswestry Disability

Questionnaire or other assessment tool;◦ clinician's objective assessment; and ◦ psychosocial screening that includes depression

and chemical dependency screening.

Process Measure

Accessed 05/18/14 at: http://www.qualitymeasures.ahrq.gov/summary_redirect.aspx?type=replaced&objectID=34201

Not addressed in most CPGs

Behavioral Measure

EXAMINATION – OUTCOME MEASURES: Clinicians should use validated self-report questionnaires such as:

◦ the Oswestry Disability Index and ◦ the Roland-Morris Disability Questionnaire.

Clinical or health outcome measures

Delitto A, et al. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57.

NASS:Spondylolisthesis

NASS:Spinal Stenosis

AAOS:Compression FX

Ortho PT: LBP

Rec. Grade A•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)

“Refer to a publication entitled Compendium of Outcome Instruments for Assessment and Research ofSpinal Disorders.”

•Pain – VAS (0-100)

•Pain – NRS (0-10)

•Oswestry Disability Index

•Roland-Morris Disability Questionnaire

•SF-36 Physical Component Summary

•AQoL

•EQ-5D

•Oswestry Disability Index

•Roland-Morris Disability Questionnaire.

Outcome Measures & CPG

CPG Aggregate score (out of 7)

NASS Spondylolisthesis 2.75

NASS Spinal Stenosis 3.40

AAOS Osteoporotic Compression Fracture

2.33

APTA: LBP 2.20

Critical analysis using AGREE II: Aggregate score on “Presenting auditing and monitoring criteria”

General Conclusion – weak in applicability due to:• weak identification of criteria to assess guideline implementation or adherence to recommendations• no provided criteria for assessing impact of implementing the recommendations• no specific advice on the frequency and interval of measurement• weak descriptions or operational definitions of how the criteria should be measured

Symptom quality: NRS Functional Status: ODI, RMDQ Quality of life: SF-36 physical component Behavioral Measure: ? Process Measure: PQRS #148-151

Outcome Measures – practical recommendations:

Based on critically analysis of 4 CPGs: NASS Spondylolisthesis, NASS Spinal Stenosis, AAOS Compression Fracture, APTA LBP

Contact Info:

Armando Miciano, M.D. Nevada Rehabilitation Institute, Las Vegas NV

www.springmountainrehab.com 702-869-4401

drmiciano@me.com

Thank You.