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”).