Transcript Measuring Signs and Symptoms in Rheumatoid Arthritis David R. Karp, MD, PhD

Measuring Signs and
Symptoms in Rheumatoid
Arthritis
David R. Karp, MD, PhD
Chief, Rheumatic Diseases
UT Southwestern Medical Center
Data Warehouse
Clinical
Research
Clinical
Care
Electronic
Health Record
Administrative
Databases
Billing
Quality Assurance
Rheumatoid Arthritis
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“Common” autoimmune disease Prevalence ~1% of population
Joint inflammation, swelling, pain,
dysfunction, and disability
Cartilage and bone destruction
Significant co-morbidities
Diagnosis of RA
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Characteristic clinical features
Presence of characteristic autoantibodies
(but only in ~80% of patients)
Presence of characteristic radiographic
findings (x-ray, MRI, or ultrasound)
Treatment of RA
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Synthetic Disease Modifying AntiRheumatic Drugs
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Biological agents (anti-cytokine)
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Methotrexate, leflunomide, sulfasalazine
Anti-TNF, anti-B cell, anti-IL-6
Combinations
Placebo (in research)
Immunopathology of RA
Unaffected
Normal (?)
Immune
System
Pre-Clinical
Clinical
Auto-Antibodies
Altered Cellular
Immunity
Inflammation
Tissue Damage
Disability
Genetics - Environment
Why we Measure RA
Determines How (Unfortunately)
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In the office
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In research
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Document to support a diagnosis and response to
therapy
(Usually) the minimum necessary to support a given
level of billing - more detail = more $
Standardized exams, lab tests, symptoms
But, too many standards
Efforts to use research standards in practice
Billable Interactions
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History (symptoms)
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Location, severity, timing, duration, quality,
context, modifying factors, and associated
“signs and symptoms”
E.g., Complains of severe (9/10), aching pain
in both hands and feet, worse in the morning,
relieved with warm water, present daily for
two weeks
Billable Interactions
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Physical Examination (signs)
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Vital Signs
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BP, pulse, respiration, temperature, height
General appearance
Inspection and palpation of the skin
Examination of the bones, joints, muscles, and
tendons for
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Alignment, tenderness, masses, effusions, etc.
Range of motion
Stability
Strength
Billable Interactions
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Data (findings)
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Laboratory tests
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Rheumatoid factor, anti-citrullinated peptide
antibodies
Radiographs
Joint space narrowing (loss of cartilage)
 Bony erosions
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Decision-making
Measuring RA in Research
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Pre-Clinical
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Auto-Antibodies (Rheumatoid Factor, anti-CCP,
others)
Genetics (HLA-DR4, others)
Biomarkers, MRI
Clinical
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Acute Phase Reactants (CRP, ESR)
Tender/Swollen Joints
Patient-Derived Measures (HAQ/Pain/Global)
MD Impression
Combined data
Safety and co-morbidity
Measures of RA Activity or
Response to Therapy
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ACR 20/50/70
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DAS 28
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FDA mandated binary measure to differentiate
placebo from active treatment
Misses partial response
May not be clinically meaningful
Empiric, continuous measure
Can identify clinical remission
Health Assessment Questionnaire
ACR 20/50/70
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20 - 50 - 70% improvement in tender and
swollen joint counts, and:
Indicated percent improvement in 3 of 5:
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ESR or CRP
Pain scale
Patient global
Physician global
Health Assessment Questionnaire
DAS 28
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Tender Joints - 0-28
Swollen Joints - 0-28
ESR or CRP
Global Health VAS (0-100)
DAS  0.56  TJC  0.28  SJC  0.36  ln(CRP 1)  0.014  GH  0.96
Taking Research Metrics to the
Clinic and Back
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Good evidence that tight control directed by
standardized measures achieves a better
functional outcome
While DAS 28 works, other scales have been
developed for “real time” assessment
How much time does it take the patient,
receptionist/RN, and physician?
Consent/HIPAA
Lack of EMR support
Not (yet) required for billing or credentialling
How do you Monitor Response/Safety in Practice?
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FREQUENTLY DONE
96% Vital Signs
81% CBC, ESR
88% AM Stiffness
83% MD Overall assessment
75% Joint Exam (Pt focused)
OFTEN DONE
68% CRP
59% PPD
54% LFTs
51% Yearly Hand X-rays
39,51% Pt Global, Pt Pain
39% Symptom survey
33% MD Global Assessment
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SELDOM DONE
27% 28 Joint count TJC,SJC
20% 66 Joint count
23% Yearly Feet X-rays
21% Yearly Chest Xray
21% Hepatitis panel
15% HAQ (some version)
16% Rheumatoid factor
12% CCP antibody
23% Urinalysis
5% MRI
1% Ultrasound
6% DAS (some version)
2.8% ACR20 (some version)
Conclusions
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Rheumatology encounters are a combination of
patient-, physician-, and test-derived information
Data collected in real life for diagnosis and
therapy, billing, and research may be different
Likely drivers for standardized data collection
will be EMR development, billing, and pay for
performance issues (“quality measures”).