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

David R. Karp, MD, PhD

Chief, Rheumatic Diseases

UT Southwestern Medical Center

ClinicalCare

ClinicalResearch

BillingQuality Assurance

ElectronicHealth Record

Data Warehouse

AdministrativeDatabases

Rheumatoid ArthritisRheumatoid 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

Diagnosis of RADiagnosis 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)

Treatment of RATreatment 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)

Immunopathology of RAImmunopathology of RA

Unaffected ClinicalPre-Clinical

Normal (?)ImmuneSystem

Auto-AntibodiesAltered CellularImmunity

InflammationTissue DamageDisability

Genetics - Environment

Why we Measure RA Determines How (Unfortunately)

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

Billable InteractionsBillable 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

Billable InteractionsBillable 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

Billable InteractionsBillable 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

Measuring RA in ResearchMeasuring 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

Measures of RA Activity or Response to Therapy

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

ACR 20/50/70ACR 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

DAS 28DAS 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)

DAS0.56 TJC 0.28 SJC 0.36ln(CRP1)0.014GH0.96

Taking Research Metrics to the Clinic and Back

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

How do you Monitor Response/Safety in Practice? 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)

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)

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 DONE68% CRP59% PPD54% LFTs51% Yearly Hand X-rays39,51% Pt Global, Pt Pain39% Symptom survey33% MD Global Assessment

ConclusionsConclusions

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”).