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Measuring Signs and Symptoms in Rheumatoid Arthritis

Measuring Signs and Symptoms in Rheumatoid Arthritis. David R. Karp, MD, PhD Chief, Rheumatic Diseases UT Southwestern Medical Center. Data Warehouse. Electronic Health Record. Administrative Databases. Clinical Research. Clinical Care. Billing Quality Assurance.

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Measuring Signs and Symptoms in Rheumatoid Arthritis

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  1. Measuring Signs and Symptoms in Rheumatoid Arthritis David R. Karp, MD, PhD Chief, Rheumatic Diseases UT Southwestern Medical Center

  2. Data Warehouse Electronic Health Record Administrative Databases Clinical Research Clinical Care Billing Quality Assurance

  3. Rheumatoid Arthritis • “Common” autoimmune disease - Prevalence ~1% of population • Joint inflammation, swelling, pain, dysfunction, and disability • Cartilage and bone destruction • Significant co-morbidities

  4. Diagnosis of RA • Characteristic clinical features • Presence of characteristic autoantibodies (but only in ~80% of patients) • Presence of characteristic radiographic findings (x-ray, MRI, or ultrasound)

  5. Treatment of RA • Synthetic Disease Modifying Anti-Rheumatic Drugs • Methotrexate, leflunomide, sulfasalazine • Biological agents (anti-cytokine) • Anti-TNF, anti-B cell, anti-IL-6 • Combinations • Placebo (in research)

  6. Immunopathology of RA Unaffected Pre-Clinical Clinical Normal (?) Immune System Auto-Antibodies Altered Cellular Immunity Inflammation Tissue Damage Disability Genetics - Environment

  7. Why we Measure RA Determines How (Unfortunately) • In the office • Document to support a diagnosis and response to therapy • (Usually) the minimum necessary to support a given level of billing - more detail = more $ • In research • Standardized exams, lab tests, symptoms • But, too many standards • Efforts to use research standards in practice

  8. Billable Interactions • History (symptoms) • 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

  9. Billable Interactions • Physical Examination (signs) • Vital Signs • BP, pulse, respiration, temperature, height • General appearance • Inspection and palpation of the skin • Examination of the bones, joints, muscles, and tendons for • Alignment, tenderness, masses, effusions, etc. • Range of motion • Stability • Strength

  10. Billable Interactions • Data (findings) • Laboratory tests • Rheumatoid factor, anti-citrullinated peptide antibodies • Radiographs • Joint space narrowing (loss of cartilage) • Bony erosions • Decision-making

  11. Measuring RA in Research • Pre-Clinical • Auto-Antibodies (Rheumatoid Factor, anti-CCP, others) • Genetics (HLA-DR4, others) • Biomarkers, MRI • Clinical • Acute Phase Reactants (CRP, ESR) • Tender/Swollen Joints • Patient-Derived Measures (HAQ/Pain/Global) • MD Impression • Combined data • Safety and co-morbidity

  12. Measures of RA Activity or Response to Therapy • ACR 20/50/70 • FDA mandated binary measure to differentiate placebo from active treatment • Misses partial response • May not be clinically meaningful • DAS 28 • Empiric, continuous measure • Can identify clinical remission • Health Assessment Questionnaire

  13. ACR 20/50/70 • 20 - 50 - 70% improvement in tender and swollen joint counts, and: • Indicated percent improvement in 3 of 5: • ESR or CRP • Pain scale • Patient global • Physician global • Health Assessment Questionnaire

  14. DAS 28 • Tender Joints - 0-28 • Swollen Joints - 0-28 • ESR or CRP • Global Health VAS (0-100)

  15. Taking Research Metrics to the Clinic and Back • 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

  16. FREQUENTLY DONE 96% Vital Signs 81% CBC, ESR 88% AM Stiffness 83% MD Overall assessment 75% Joint Exam (Pt focused) 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) How do you Monitor Response/Safety in Practice? 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

  17. Conclusions • 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”).

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