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

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

3. Rheumatoid Arthritis “Common” autoimmune disease - Prevalence ~1% of population Joint inflammation, swelling, pain, dysfunction, and disability Cartilage and bone destruction Significant co-morbidities “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) Characteristic clinical features Presence of characteristic autoantibodies (but only in ~80% of patients) Presence of characteristic radiographic findings (x-ray, MRI, or ultrasound)

8. 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) 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)

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

10. 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 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

11. 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 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

12. 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 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

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

14. 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 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

15. 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 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

16. 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 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

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

18. 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 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

20. How do you Monitor Response/Safety in Practice? 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) 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

21. 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”). 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”).