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 BermanUniversity of Maryland School of Medicine and The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
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.
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
WOMAC Scores by OMERACT-OARSI Response
05
10
15
2025
30
35
40
45
WOMAC Pain WOMAC Function WOMAC Total
Responders Nonresponders
HAQ Scores by OMERACT-OARSI Response
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
HAQ Pain HAQ Disability
Responders Nonresponders
EuroQoL Scores by OMERACT-OARSI Response
01020
304050
607080
90
EQ-5D EQ-VAS
Responders Nonresponders
SF-36 Scores by OMERACT-OARSI Response
010
20
3040
50
60
7080
90
PF RP Pain GH MH V RE SA
Responders Nonresponders
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.
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
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
State Measures in OA Patients
MCII– Pain 177 (33%)– Function 220 (41%)– Global 136 (25%)
PASS– Pain 241 (44%)– Function 221 (41%)– Global 177 (33%)
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.
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
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
KOOS
Validated in several populations– Surgical reconstruction of ACL– Knee arthroscopy– Meniscectomy 16 years previously– Total knee arthroplasty– Autologous cartilage transplantation
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
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
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”
Prevention of the Occurrence of Incident OA Definition of incident OA
– Structural• Arthroscopy• Radiography• MRI
– Symptomatic
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 biopsiesKnutsen et al: J Bone Jt Surg 2004;86-A:455-64
Thank you for your time and attention.