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Moving Towards Patient-Centered Treatment Guidelines for Knee and Hip OA

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Moving Towards Patient-Centered Treatment
Guidelines for Knee and Hip OA
Prepared by: the Center for Treatment Comparison ...

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Disclosures
• Sponsored by a grant from OARSI
• OARSI gratefully acknowledges support from:
 Arthritis Foundation
 Versu...

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Guideline Scope
The target audience for this guideline includes patients
with Knee, Hip, or Polyarticular Osteoarthritis, ...

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Moving Towards Patient-Centered Treatment Guidelines for Knee and Hip OA

  1. 1. Moving Towards Patient-Centered Treatment Guidelines for Knee and Hip OA Prepared by: the Center for Treatment Comparison and Integrative Analysis (CTCIA) Presented by: Raveendhara R. Bannuru & Timothy E. McAlindon Tufts Medical Center Boston, US
  2. 2. Disclosures • Sponsored by a grant from OARSI • OARSI gratefully acknowledges support from:  Arthritis Foundation  Versus Arthritis (formerly Arthritis Research UK)  ReumaNederlands (formerly Reumafonds) • No industry funding was received for the OARSI guidelines. 2
  3. 3. Guideline Scope The target audience for this guideline includes patients with Knee, Hip, or Polyarticular Osteoarthritis, and their clinicians. 3
  4. 4. Goals of this Guideline • Patient-centered Recommendations  Three OA phenotypes o Knee o Hip o Polyarticular  “Precision Medicine”: Five comorbidity groups o None o Gastrointestinal o Cardiovascular o Frailty o Widespread pain disorder (e.g. fibromyalgia) and/or depression 4
  5. 5. The 2019 Guidelines Team • Core Expert Panel  Defined project scope  Crafted clinical questions  Coordinated all aspects of the project • Literature Review Team  Conducted literature review  Graded evidence quality  Produced evidence report with summary of findings • Voting Panel  Voted on clinical questions to produce recommendations 5
  6. 6. Locations of our Panel Members 13 Voting Panel members from 10 countries 6 Core Expert Panel members from 4 countries 6
  7. 7. Expertise of the Voting Panel Members Orthopaedic Surgeon Physiotherapist Sports Medicine Rheumatologist General Practitioner 7
  8. 8. Methods
  9. 9. Systematic evidence review Guideline development Literature review team Formulating Recommendation Statements through the GRADE Process Core team & content expertsExpert voting panel 9
  10. 10. Systematic evidence review Guideline development P I C O 10
  11. 11. Systematic evidence review Guideline development P I C O opulation ntervention omparator utcomes 11
  12. 12. Systematic evidence review Guideline development P I C O Outcome Outcome Outcome Outcome Critical Important Critical Summary of findings & estimate of effect for each outcome Grade overall quality of evidence across outcomes based on lowest quality of critical outcomes Very low Low Moderate High Develop consensus By considering balance of: Quality of evidence; Balance benefits/harms; Values and preferences Formulate Recommendations ( | …) •“We strongly recommend using…” •“We conditionally recommend using…” •“We strongly recommend not using…” •“We conditionally recommend not using…” Guideline 12
  13. 13. Methodology: GRADE • We adapted GRADE methodology to accommodate the evidence body for OA  Strict, objective criteria for risk of bias, inconsistency, indirectness, and imprecision were determined a priori  We selected two Critical Outcomes to accurately reflect overall Quality of Evidence  Transparently displayed percentage gradients from Voting Sessions 13
  14. 14. Outcomes of interest 14
  15. 15. Flow of Evidence into the Guideline Articles reviewed for Title and Abstract Screening (n = 12,535) Records identified from Medline, PubMed, EMBASE, Google Scholar, and Cochrane Database (December, 2017) (n = 11,760) Total excluded (n =11,345) Full-text articles assessed for eligibility (n = 1,190) Studies matched to PICOs (n = 407) Full-text articles excluded (n = 783) Search update (July, 2018) (n = 775) 15
  16. 16. Definitions- Treatments • Core Treatment: Treatment that is recommended for use in a majority of patients at any point during the course of treatment, as appropriate 16
  17. 17. Definitions- Treatments • Primary Treatment (Level 1A): First selection of treatment(s) if Core Treatment(s) alone are insufficient • Secondary Treatment (Level 1B or Level 2): Next selection of treatment(s) if Primary Treatment(s) are insufficient 17
  18. 18. Voting • Voting Panel members anonymously indicated their level of recommendation for 3 OA phenotypes and 5 comorbidity characteristics. 18
  19. 19. Voting Sequence Core Treatments • Chosen from a list of nominee Core Treatments • Included all treatments not selected as Core and classified as Non- Pharmacologic Pharmacologic Treatments • Included all treatments not selected as Core and classified as Pharmacologic Nutraceuticals • Included all treatments not selected as Core and classified as Nutraceuticals Non-Pharmacologic Treatments 19
  20. 20. Voting A list of the nominee Core Treatments was agreed upon by the Expert Panel a priori:  Structured Land-based Exercise Programs  Aquatic Exercise  Self-Management Programs  Mind-body Exercise  Dietary Weight Management  Cognitive Behavioral Therapy  Orthopedic Footwear  Gait Aids  Paracetamol (short-term, intermittent use)  Thermotherapy  Realigning Patellofemoral Braces  Soft Braces/Knee Sleeves Each Voting Member viewed a summary of the evidence for each treatment. Very Low Quality studies were excluded from the main summaries. The Voting Member received a link to a full GRADE report of the evidence and was asked to vote “Yes” or “No” to include the treatment as a Core Treatment The full report provided GRADE tables with references and grading rationales. Supplementary Analyses including Very Low Quality studies were also provided. Funding Sources were reported for all interventions included in the Evidence Report, and Voting Panel members had full disclosure of this information during Voting. Core Treatments 20
  21. 21. • Voting on primary and secondary treatments was structured as a matrix to allow for GRADE-specific strength and direction of recommendation Voting For each treatment, Voting Panel Members were able to make recommendations for patients with Knee, Hip, or Polyarticular OA, with or without a wide range of comorbidities. Treatments were either recommended or not recommended, and the strength of the recommendation was graded as “strong” or “conditional” Voting Panel Members were shown evidence summaries, as in Core Treatment Voting. Links to the full Evidence Report were provided……as well as Supplementary Analyses including Very Low Quality evidence… …and Funding Sources. Pharmacologic Treatments Nutraceuticals Non-Pharmacologic Treatments 21
  22. 22. Translating Voting Data into the Treatment Algorithm Level % in favor % against % Conditional/strong Level 1A 75-100 0-25 >50 strong Level 1B 75-100 0-25 >50 conditional Level 2 60-74 26-40 conditional by default Level 3 41-59 41-59 conditional by default Level 4B 26-40 60-74 conditional by default Level 4A 0-25 75-100 >50 conditional Level 5 0-25 75-100 >50 strong 22
  23. 23. Results
  24. 24. Preliminary Recommendations • The final output was a series of detailed tables that displayed recommendations by level and by comorbidity subgroup 24
  25. 25. Core Treatments for Knee OA • Arthritis Education as Standard of Care • Structured Land-based Exercise Programs  Type 1: Strengthening and/or cardio and/or balance training/neuromuscular exercise  Type 2: Mind-body Exercise, including Tai Chi or Yoga • Dietary Weight Management + Exercise 25
  26. 26. Core Treatments for Hip & Polyarticular OA • Arthritis Education as Standard of Care • Structured Land-based Exercise Programs  Type 1: Strengthening and/or cardio and/or balance training/neuromuscular exercise 26
  27. 27. Primary and Secondary Treatments for Knee OA Gastrointestinal Comorbidity• Level 1A:  Refer to Level 1B • Level 1B:  Non-selective NSAID + PPI  COX-2 Inhibitors  Gait Aids  Aquatic Exercise  Cognitive Behavioral Therapy (with or without Exercise)  Self-Management Programs • Level 2:  Duloxetine  IACS  IAHA  Topical NSAIDs • Level 1A:  Topical NSAIDs • Level 1B:  Oral COX-2 Inhibitors  IACS  IAHA  Gait Aids  Aquatic Exercise  Self-Management Programs • Level 2:  Oral Non-selective NSAIDs (with PPI)  Cognitive Behavioral Therapy with Exercise No Comorbidities • Level 1A:  Topical NSAIDs • Level 1B:  Oral Non-selective NSAIDs (with PPI)  Oral COX-2 Inhibitors  IACS  Gait Aids  Aquatic Exercise  Self-Management Programs • Level 2:  Intra-articular Hyaluronic Acid (IAHA)  Cognitive Behavioral Therapy with Exercise Widespread Pain/Depression 27
  28. 28. Primary and Secondary Treatments for Hip OA Cardiovascular Comorbidity • Level 1A:  Refer to Level 1B • Level 1B:  Gait Aids  Mind-body Exercise  Self-Management Programs • Level 2:  NA No Comorbidities • Level 1A:  Refer to Level 1B • Level 1B:  Oral Non-selective NSAIDs  IACS  Gait Aids  Mind-body Exercise  Self-Management Programs • Level 2:  Oral Non-selective NSAIDs (with PPI)  Oral COX-2 Inhibitors 28
  29. 29. Primary and Secondary Treatments for Polyarticular OA No Comorbidities • Level 1A:  Refer to Level 1B • Level 1B:  Oral Non-selective NSAIDs  Gait Aids  Mind-body Exercise  Dietary Weight Management (with or without Exercise)  Self-Management Programs • Level 2:  Oral Non-selective NSAIDs (with PPI)  Oral COX-2 Inhibitors Widespread Pain/Depression • Level 1A:  Refer to Level 1B • Level 1B:  Gait Aids  Mind-body Exercise  Cognitive Behavioral Therapy  Dietary Weight Management (with or without Exercise)  Self-Management Programs • Level 2:  Oral Non-selective NSAIDs (with PPI)  Oral COX-2 Inhibitors 29
  30. 30. What did Patients Want to See? • Patient representatives requested a complete list of strongly NOT recommended treatments, as well as the rationales behind these recommendations. 30
  31. 31. Highlights • Mind-body Exercise as Core for Knee OA • Topical NSAIDs strongly recommended for Knee OA • Certain oral NSAIDs not recommended within specific comorbidity classes • APAP not recommended • Opioids were not recommended • Duloxetine recommended for patients with concomitant depression ONLY 31
  32. 32. Good Clinical Practice Statements • Supplementary to treatment recommendations and made based on the practical experience of Panel Members. • Included:  Weight management: recommended for certain patients (BMI ≥30 kg/m2) as part of a healthy lifestyle  NSAID risk mitigation: advises lowest possible dose of any NSAID for short treatment duration in patients with comorbidities  Intra-articular treatment: describes the short-term vs. long-term utility and safety of IACS vs. IAHA  Pain management program: suggests multidisciplinary options for chronic/widespread pain 32
  33. 33. Treatment Algorithm Initial Assessment: 1. Identify location of OA 2. Diagnose comorbidities 3. Assess clinical status a. Pain, function, stiffness b. Effusion, instability, malalignment 4. Assess emotional & environmental status a. Social network b. Health beliefs & expectations c. Mood d. Sleep quality e. Occupational factors Select one or more Core Treatment(s) After initial assessment, proceed to patient-centered pathways 33
  34. 34. Treatment Algorithm Secondary Options: Select a Level 1B or Level 2 treatment from. Refer to Good Clinical Practice Statements as appropriate. Reassessment of diagnosis and pragmatic discussion. Consider referral to pain clinic or orthopedic consultation Primary Options: Select a Level 1A treatment. IF no Level 1A treatment, select a Level 1B treatment . Refer to Good Clinical Practice Statements as appropriate. Acceptable State: Maintain current treatment regimen as needed Re-assess as needed PATIENT-CENTERED Re-assess regularly Re-assess as needed Review and/or Select one or more Core Treatment(s) Review and/or Select one or more Core Treatment(s) Review and/or Select one or more Core Treatment(s) 34
  35. 35. Treatment Algorithm- Case Initial Assessment: 1. Knee OA 2. Hypertension, Overweight 3. Assess clinical status a. Pain, function, stiffness b. Effusion, instability, malalignment 4. Assess emotional & environmental status a. Social network b. Health beliefs & expectations c. Mood d. Sleep quality e. Occupational factors Structured Land-based Exercise & Dietary Weight Management After initial assessment, proceed to patient-centered pathways 35
  36. 36. Treatment Algorithm Secondary Options: Try IACS Reassessment of diagnosis and pragmatic discussion. Consider referral to pain clinic or orthopedic consultation Primary Options: Try Topical NSAIDs Acceptable State: Maintain current treatment regimen as needed Re-assess as needed PATIENT-CENTERED Re-assess regularly Re-assess as needed Maintain Diet & Structured Exercise Review Diet & Structured Exercise Switch to Mind-body Exercise & Maintain Diet Try IAHATry Aquatic Exercise If NSAIDs are used in this patient: Lowest possible dose of NSAID for short treatment duration (1-4 weeks) along with gastric protection with a PPI. 36
  37. 37. Acknowledgements Core Expert Panel Voting Panel • Raveendhara R. Bannuru • Kim Bennell • Sita Bierma-Zeinstra • Virginia Kraus • Stefan Lohmander • Timothy E. McAlindon • J. Haxby Abbott • Nigel Arden • Mohit Bhandari • Francisco Blanco • Rolando Espinosa • Ida K. Haugen • Jianhao Lin • Lisa Mandl • Eeva Moilanen • Norimasa Nakamura • Lynn Snyder-Mackler • Thomas Trojian • Martin Underwood Literature Review Panel • Raveendhara R. Bannuru • Timothy E. McAlindon • Mikala C. Osani • Elizaveta E. Vaysbrot 37
  38. 38. Acknowledgements • Patient Representatives  Angie Botton van Bemden  Ingrid Lether  Sarah Rudkin  Maartin de Wit • Funders  Arthritis Foundation  Versus Arthritis  ReumaNederlands • OARSI  Diann Stern  Tufts Support  Daniela Cunha 38
  39. 39. Any Questions for Us? 39

Editor's Notes

  • Land-based Exercise (100% “yes”)
    Dietary Weight Management + Exercise (92.3% “yes”)
    Mind-body Interventions (84.6% “yes”)
    Aquatic Exercise (76.9% “no”)
    Self-Management Education (58.3% “no”)
    Dietary Weight Management (50% “no”)
    Orthopedic Footwear (92.3% “no”)
    Gait Aids (41.7% “no”)
    Paracetamol (69.2% “no”)
    Thermotherapy (100% “no”)
    Cognitive Behavioral Therapy (61.5% “no”)
    Cognitive Behavioral Therapy + Exercise (61.5% “no”)
    Soft Braces/Knee Sleeves (100% “no”)
    Realigning Patellofemoral Braces (91.7% “no”)
  • Land-based Exercise (84.6% “yes”)
    Aquatic Exercise (100% “no”)
    Self-Management Education (69.2% “no”)
    Mind-body Interventions (53.8% “no”)
    Dietary Weight Management (84.6% “no”)
    Dietary Weight Management + Exercise (53.8% “no”)
    Gait Aids (69.2% “no”)
    Paracetamol (76.9% “no”)
    Thermotherapy (100% “no”)
    Cognitive Behavioral Therapy (53.8% “no”)
    Cognitive Behavioral Therapy + Exercise (92.3% “no”)
  • Expand to 5 slides
  • Comorbidity/Phenotype Determined from items 1 and 2 from the Initial Assessment, and subsequent Re-assessments

    **Assess current symptom state and potential side effects, document changes since the previous assessment. “Acceptable State” indicates that the patient and clinician agree that the current symptom state is acceptable.

    † For “Not Acceptable” State: Approximate patient’s adherence up to that point; if inadequate, explore barriers to adherence and/or adjust the intervention dosage. Assess the effectiveness of the current dosage; modify dosage if necessary and resume the regimen.
  • *Comorbidity/Phenotype Determined from items 1 and 2 from the Initial Assessment, and subsequent Re-assessments

    **Assess current symptom state and potential side effects, document changes since the previous assessment. “Acceptable State” indicates that the patient and clinician agree that the current symptom state is acceptable.

    † For “Not Acceptable” State: Approximate patient’s adherence up to that point; if inadequate, explore barriers to adherence and/or adjust the intervention dosage. Assess the effectiveness of the current dosage; modify dosage if necessary and resume the regimen.
  • Comorbidity/Phenotype Determined from items 1 and 2 from the Initial Assessment, and subsequent Re-assessments

    **Assess current symptom state and potential side effects, document changes since the previous assessment. “Acceptable State” indicates that the patient and clinician agree that the current symptom state is acceptable.

    † For “Not Acceptable” State: Approximate patient’s adherence up to that point; if inadequate, explore barriers to adherence and/or adjust the intervention dosage. Assess the effectiveness of the current dosage; modify dosage if necessary and resume the regimen.
  • *Comorbidity/Phenotype Determined from items 1 and 2 from the Initial Assessment, and subsequent Re-assessments

    **Assess current symptom state and potential side effects, document changes since the previous assessment. “Acceptable State” indicates that the patient and clinician agree that the current symptom state is acceptable.

    † For “Not Acceptable” State: Approximate patient’s adherence up to that point; if inadequate, explore barriers to adherence and/or adjust the intervention dosage. Assess the effectiveness of the current dosage; modify dosage if necessary and resume the regimen.
  • Voting panel- for their vital role in making the recommendations a reality!
    Expert Panel for their guidance and expertise throughout the process
    OARSI, support
    Daniela Cunha for preparing and coordinating Voting Sessions

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