Armando Miciano, M.D. Nevada Rehabilitation Institute, Las Vegas NV 2014 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

 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 # , 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) GAO. Clinical Data Registries Accessed 10/20/14 at:

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

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. Accessed 10/20/14 at: 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 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; p.

SpondylolisthesisSpinal StenosisCompression FxAPTA LBP CPG Reviewed by a group experienced in performance measure development to identify those recommendations rigorous enough for measure development. All relevant medical specialties involved in the guideline development and at the Consortium will be invited to collaborate in the development of evidence-based performance measures related to spine care. Reviewed by a group experienced in performance measure development to identify those recommendations rigorous enough for measure development. All relevant medical specialties involved in the guideline development and at the Consortium will be invited to collaborate in the 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

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

 “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 tail.aspx?Product_ tail.aspx?Product_ “For additional information about the Compendium, please contact the NASS Research Department at Accessed 10/20/14 at: 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 Accessed 10/20/14 at:

 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. Accessed 10/20/14 at:

 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. Accessed 10/20/14 at:

Outcome MeasureMCII (points) Pain – VAS (0-100)15 Pain – NRS (0-10) 2 Oswestry Disability Index10 Roland-Morris Disability Questionnaire 5 SF-36 Physical Component Summary 4.9 AQoL0.06 EQ-5D0.074 Accessed 10/20/14 at: ine.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 Accessed 10/20/14 at: dated_Guidelines/Low_Back_Pain_Clinical_Practice_Gui delines___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.) Accessed 10/20/14 at: ines/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 [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 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] [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 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 National Quality Forum – Measure no. 322: Back Pain Initial Visit. Accessed 05/18/14 at: -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 National Quality Forum – Measure no. 306: Back Pain Patient Reassessment. Accessed 05/18/14 at: 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. Accessed 05/18/14 at: ype=replaced&objectID=34201

 Not addressed in most CPGs

 EXAMINATION – OUTCOME MEASURES: Clinicians should use validated self-report questionnaires such as: ◦ the Oswestry Disability Index and ◦ the Roland-Morris Disability Questionnaire. Delitto A, et al. J Orthop Sports Phys Ther 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 of Spinal 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.

CPGAggregate score (out of 7) NASS Spondylolisthesis2.75 NASS Spinal Stenosis3.40 AAOS Osteoporotic Compression Fracture 2.33 APTA: LBP2.20 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 # 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