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Validation of the OMERACT-OARSI Responder Index: Responders Have Better Overall Health Status than Non-responders

Validation of the OMERACT-OARSI Responder Index: Responders Have Better Overall Health Status than Non-responders. Marc C. Hochberg, Barker Bausell, Kevin Frick, Donald Steinwachs and Brian Berman

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Validation of the OMERACT-OARSI Responder Index: Responders Have Better Overall Health Status than Non-responders

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  1. Validation of the OMERACT-OARSI Responder Index:Responders Have Better Overall Health Status than Non-responders Marc C. Hochberg, Barker Bausell, Kevin Frick, Donald Steinwachs and Brian Berman University of Maryland School of Medicine and The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA

  2. Objective • To validate the OMERACT-OARSI Responder Index • Test the hypothesis that patients with knee OA participating in a clinical trial who fulfil the OMERACT-OARSI Responder Index will have better overall health status as measured by both arthritis-specific and general measures.

  3. Comparison of Outcomes by OMERACT-OARSI Response • 236 (41.4%) of 570 patients randomized achieved an OMERACT-OARSI Response at the end of study • 61% of 386 completers

  4. WOMAC Scores by OMERACT-OARSI Response

  5. HAQ Scores by OMERACT-OARSI Response

  6. EuroQoL Scores by OMERACT-OARSI Response

  7. SF-36 Scores by OMERACT-OARSI Response

  8. Conclusion • These data validate the OMERACT-OARSI Responder Index. • Results unchanged when analysis performed only with completers (N = 386) • OMERACT-OARSI Responder Index should be considered as primary outcome for clinical trials of symptomatic therapies in patients with OA.

  9. State Measures - 2 • Minimal Clinically Important Improvement (MCII) • Smallest change in measurement that signifies an important improvement in a patient’s symptom • 75%ile of distribution of change score among those who had good or excellent improvement with therapy Tubach F et al: Ann Rheum Dis 2005;64:29-33

  10. State Measures - 2 • Patient Acceptable Symptom State (PASS) • Value in a measurement of a patient’s symptom beyond which the patient considers herself well • 75%ile of distribution of absolute score among those who are satisfied with their current state after therapy Tubach F et al: Ann Rheum Dis 2005;64:34-7

  11. MCII Pain 177 (33%) Function 220 (41%) Global 136 (25%) PASS Pain 241 (44%) Function 221 (41%) Global 177 (33%) State Measures in OA Patients Highly significant association between achieving an OMERACT-OARSI Response and having either an MCII or a PASS for each of the 3 domains, especially pain and function.

  12. Knee Rating Scales for Athletic Patients • Modified Lysholm Scale • Cincinnati Knee Rating System • AAOS Sports Knee Rating Scale • ADL Scale of the Knee Outcome Survey • Single Assessment Numeric Evaluation • Knee Injury and OA Outcome Score • QoL Outcome Measure for Chronic ACL Def • International Knee Documentation Committee Marx RG: Arthroscopy 2003;19:1103-8

  13. KOOS • Evaluates both short- and long-term consequences of knee injury • 42 items in 5 separately scored domains • Pain • Other symptoms • Function in daily living • Function in sport and recreation • Knee-related quality of life

  14. KOOS • Validated in several populations • Surgical reconstruction of ACL • Knee arthroscopy • Meniscectomy 16 years previously • Total knee arthroplasty • Autologous cartilage transplantation

  15. KOOS • Reliable • Responsive • Effect sizes > 1.0 for all 5 subscales in patients undergoing arthroplasty and tibial osteotomy • Effect sizes > 0.5 for all 5 subscales in patients undergoing ACL reconstruction and meniscectomy

  16. KOOS vs. WOMAC • KOOS contains WOMAC pain, function and stiffness subscales (Likert v3.0) • KOOS adds 18 questions covering sport and recreational function, knee-related quality of life and other symptoms • Larger effect sizes with KOOS • Younger subjects with knee injury • Older subjects with total knee arthroplasty

  17. Summary • There are numerous options for assessing clinically relevant outcomes in trials of products used for cartilage repair • KOOS is the recommended self-report measure of pain, function and QoL • “http://www.koos.nu”

  18. Prevention of the Occurrence of Incident OA • Definition of incident OA • Structural • Arthroscopy • Radiography • MRI • Symptomatic

  19. ACI Compared with Microfracture in the Knee • RCT: 80 patients followed for 2 years • Similar clinical outcomes • Lysholm and VAS pain score • Significant difference in SF-36 PCS favoring microfracture group • Similar structural outcomes • Arthroscopy • Histology of cartilage biopsies Knutsen et al: J Bone Jt Surg 2004;86-A:455-64

  20. Thank you for your time and attention.

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