Monitoring Criteria: The Role of Patient-Reported Outcomes in CLBP.

1. Monitoring Criteria: The Role of Patient-Reported Outcomes in CLBP. Armando Miciano, M.D. Nevada Rehabilitation Institute, Las Vegas NV 2014 AAPMR Annual Assembly, San Diego CA, 2014 Nov 14

2. Course section – Learning Objectives • 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

3. Glossary: Performance Measures • 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) GAO. Clinical Data Registries. 2013. Accessed 10/20/14 at: http://www.gao.gov/assets/660/659701.pdf

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

5. LBP CPG available via AAPMR website links 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: http://www.aapmr.org/research/practice-guidelines/Pages/Applicable-PMR-Guidelines.aspx

6. “Other CLBP CPG” • 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.

7. Identification and Development ofPerformance Measures

8. What are the appropriateoutcome measures for thetreatment of ……SPONDYLOLISTHESIS

9. What are the appropriateoutcome measures for thetreatment of ……SPINAL STENOSIS • “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.” Accessed 10/20/14 at: https://www.spine.org/Documents/ResearchClinicalCare/Guidelines/LumbarStenosis.pdf

10. What are the appropriateoutcome measures for thetreatment of ……SPINAL STENOSIS 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: http://www.guideline.gov/content.aspx?id=34839

11. What are the appropriate outcome measures for the treatment of ……COMPRESSION FRACTURE • 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: http://www.aaos.org/research/guidelines/SCFguideline.pdf

12. MINIMAL CLINICALLY IMPORTANT IMPROVEMENT (MCII) • 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: http://www.aaos.org/research/guidelines/SCFguideline.pdf

13. MCII (also as MCID) VAS – Visual Analog Scale; NRS – Numerical Rating Scale; AQOL – Assessment of Quality of Life; Accessed 10/20/14 at: http://www.aaos.org/research/guidelines/SCFguideline.pdf

14. What are the appropriate outcome measures for the treatment of ……LBP (per APTA)? 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: http://www.orthopt.org/uploads/content_files/ICF/Updated_Guidelines/Low_Back_Pain_Clinical_Practice_Guidelines___JOSPT_2012.pdf

15. What are the appropriate outcome measures for the treatment of ……LBP (per APTA)? 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: http://www.orthopt.org/uploads/content_files/ICF/Updated_Guidelines/Low_Back_Pain_Clinical_Practice_Guidelines___JOSPT_2012.pdf

16. Weakness – LBP CPG: Presentation of monitoring/auditing criteria. • 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 http://www.agreetrust.org . P. 36

17. Presentation of monitoring/auditing criteria: How to rate LBP CPG • 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 http://www.agreetrust.org . P. 36

18. Process Measure • 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: http://www.aapmr.org/research/performance/pmrmeasures/Pages/Low-Back-Pain-Measures.aspx

19. Process Measure • 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: http://www.aapmr.org/research/performance/pmrmeasures/Pages/Low-Back-Pain-Measures.aspx

20. Process Measure • 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: http://www.qualitymeasures.ahrq.gov/summary_redirect.aspx?type=replaced&objectID=34201

21. Behavioral Measure • Not addressed in most CPGs

22. Clinical or health outcome measures • 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. 2012 Apr;42(4):A1-57.

23. Outcome Measures & CPG

24. 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

25. Outcome Measures – practical recommendations: • Symptom quality: NRS • Functional Status: ODI, RMDQ • Quality of life: SF-36 physical component • Behavioral Measure: ? • Process Measure: PQRS #148-151 Based on critically analysis of 4 CPGs: NASS Spondylolisthesis, NASS Spinal Stenosis, AAOS Compression Fracture, APTA LBP

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