RULES TO REDUCE FROM 63 10/25/2013 DISCLOSURES EVIDENCE BASED MEDICINE

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Franklin May
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1 DISCLOSURES No Conflicts of Interest to Disclose WHICH RA DISEASE ACTIVITY MEASURES TO USE IN PRACTICE Mark Robbins, M.D. MPH Co-Chair Quality Measures ACR Atrius Health - Boston My primary involvement with the RA Disease Activity Workgroup was in major revisions of the original draft. Acknowledge that Kaleb Michaud graciously gave me license to use slides outlining the stepwise process and decisions along the way. EVIDENCE BASED MEDICINE Anderson et al. Rheumatoid Arthritis Disease Activity Measures: American College of Rheumatology Recommendations for Use in Clinical Practice. Arthritis Care and Research Anderson et al. Measures of Rheumatoid Arthritis Disease Activity... Arthritis Care and Research Maska et al. Measures of Functional Status and Quality of Life in Rheumatoid Arthritis. Arthritis Care and Research ACR DISEASE ACTIVITY MEASURES PROJECT WORKING GROUP Mission: Comprehensively evaluate the validity, feasibility, and acceptability of available RA disease activity measures (DAM). Derive recommendations for their use in clinical practice Translation: Let s figure out what you should measure for RA in your clinic! Let s allow enough flexibility in measure selection that different practice environments (small single specialty vs. large multispecialty and academic medical centers) with different priorities and levels of support can pick the best measure for their needs. SYSTEMATIC REVIEW FOUND 63 RA DAMS! Multidimensional Health Assessment Rheumatoid Arthritis Impact of Disease ACR Core Set American College of Rheumatology Core Set RAID Questionnaire Score American College of Rheumatology Hybrid ACR Hybrid mhaq Modified Health Assessment Questionnaire RAPID 2 Response Measure with 2 measures ACR-N American College of Rheumatology - N MJS Mechanical Joint Score RAPID 3 with 3 measures AIMS Arthritis Impact Measurement Scale MSS Modified Sharp Score RAPID4MDJC with 4 measures and MD Joint Count Arthritis Impact Measurement Scale Revised AIMS2 MOI-RA Mean Overall Index for Rheumatoid Arthritis RAPID4PTJC Version with 4 measures and Patient Joint Count CASI Chronic Arthritis Systemic Index Mallya and Mace Mallya and Mace Index RAPID 5 with 5 measures CDAI Chronic Disease Activity Index NHP Nottingham Health Profile RAQoL Rheumatoid Arthritis Quality of Life Cochin Rheumatoid Arthritis Hand Functional Cochin NOAR Norfolk Arthritis Register Damaged RASS Rheumatoid Arthritis Severity Scale Joint Count Disability Scale DAS Disease Activity Score OSRA Overall Status in Rheumatoid Arthritis Riel Riel Index DAS 28 Disease Activity Score with 28 Joint Counts PAS Patient Activity Scale ROAD Index Recent-Onset Arthritis Disability Index Score for Assessment and Quantification of EULAR European League Against Rheumatism Core PASII Patient Activity Scale II SACRAH Set Chronic Rheumatic Affections of the Hands EuroQoL European Quality of Life Measure Paulus Paulus Criteria Scott Scott Index GAS Global Arthritis Score PDAS1 Patient-Based Disease SDAI Simplified Disease Activity Index Activity Score with ESR HAQ Health Assessment Questionnaire PDAS2 Patient-Based Disease Activity Score without ESR SF-36 Short Form 36-Item Health Survey Short Form 36-Item Arthritis Specific HAQ-II Health Assessment Questionnaire Pooled Pooled Index SF-36 ASHI II Health Index Provider Global Assessment of Disease Activity HRAS38 Handy RA Activity Score with 38 Joints PrGlobal Sharp Score Sharp Score Patient Global Assessment of Disease Activity IDA Index of Disease Activity PtGlobal SIP Sickness Impact Profile Lansbury Lansbury Index RADAI Rheumatoid Arthritis Disease Activity Index Stoke Index Stoke Index Larsen Larsen Score RADAI 5 Rheumatoid Arthritis Disease Activity Index 5 TSC Therapeutic Score Card Mean Percentage of Improvement in the American Rapid Assessment of Disease Activity in World Health Organization and macr RADAR WHO/ILAR International League Against Rheumatism College of Rheumatology 7 Core Set Measures Rheumatology Response Criteria Real Time Assessment of Disease Activity in World Health Organization Disability MAL Measurement of Activity Limitation RADARA WHODASII Rheumatoid Arthritis Assessment Schedule II RULES TO REDUCE FROM 63 Measured radiographic changes only: 3 Did not report a continuous value: 5 Pertained only to joint damage or disability: 3 Had insufficient information: 5 RADAMs remaining: 47 1

2 RULES TO REDUCE FROM 47 Not recommend by expert panel: 14 Measured quality of life: 10 Required calculation of change score: 2 Antiquated measure: 1 Pertains only to single body region: 1 RADAMs remaining: 19 RULES TO REDUCE FROM 19 Lacked Remission Criteria: 5 Submitted to ACR membership (N=335) Ranked low: 5 Low use reported: 1 Lacked well-defined disease activity categories: 2 RADAMs remaining: 6! FROM 63 TO 6 ACR Core Set American College of Rheumatology Core Set Multidimensional Health Assessment Questionnaire RAID American College of Rheumatology Hybrid ACR Hybrid mhaq Modified Health Assessment Questionnaire RAPID 2 Response Measure ACR-N American College of Rheumatology - N MJS Mechanical Joint Score RAPID 3 Rheumatoid Arthritis Impact of Disease Score with 2 measures with 3 measures FINAL LIST OF 6 RA DAMS AIMS Arthritis Impact Measurement Scale MSS Modified Sharp Score RAPID4MDJC with 4 measures and MD Joint Count Arthritis Impact Measurement Scale Revised AIMS2 MOI-RA Mean Overall Index for Rheumatoid Arthritis RAPID4PTJC Version with 4 measures and Patient Joint Count CASI Chronic Arthritis Systemic Index Mallya and Mace Mallya and Mace Index RAPID 5 with 5 measures CDAI Chronic Disease Activity Index NHP Nottingham Health Profile RAQoL Rheumatoid Arthritis Quality of Life Cochin Rheumatoid Arthritis Hand Functional Cochin NOAR Norfolk Arthritis Register Damaged RASS Rheumatoid Arthritis Severity Scale Joint Count Disability Scale DAS Disease Activity Score OSRA Overall Status in Rheumatoid Arthritis Riel Riel Index DAS 28 Disease Activity Score with 28 Joint Counts PAS Patient Activity Scale ROAD Index Recent-Onset Arthritis Disability Index Score for Assessment and Quantification of EULAR European League Against Rheumatism Core PASII Patient Activity Scale II SACRAH Set Chronic Rheumatic Affections of the Hands EuroQoL European Quality of Life Measure Paulus Paulus Criteria Scott Scott Index GAS Global Arthritis Score PDAS1 Patient-Based Disease SDAI Simplified Disease Activity Index Activity Score with ESR HAQ Health Assessment Questionnaire PDAS2 Patient-Based Disease Activity Score without ESR SF-36 Short Form 36-Item Health Survey Short Form 36-Item Arthritis Specific HAQ-II Health Assessment Questionnaire Pooled Pooled Index SF-36 ASHI II Health Index Provider Global Assessment of Disease Activity HRAS38 Handy RA Activity Score with 38 Joints PrGlobal Sharp Score Sharp Score Patient Global Assessment of Disease Activity IDA Index of Disease Activity PtGlobal SIP Sickness Impact Profile Lansbury Lansbury Index RADAI Rheumatoid Arthritis Disease Activity Index Stoke Index Stoke Index DAS-28 Disease Activity Score 28 joints CDAI Chronic Disease Activity Index SDAI Simplified Disease Activity Index RAPID-3 Routine Assessment of Patient Index Data w 3 measures PAS Patient Activity Scale PAS-II Patient Activity Scale II Larsen Larsen Score RADAI 5 Rheumatoid Arthritis Disease Activity Index 5 TSC Therapeutic Score Card Mean Percentage of Improvement in the American macr RADAR College of Rheumatology 7 Core Set Measures MAL Measurement of Activity Limitation RADARA Rapid Assessment of Disease Activity in Rheumatology Real Time Assessment of Disease Activity in Rheumatoid Arthritis WHO/ILAR WHODASII World Health Organization and International League Against Rheumatism Response Criteria World Health Organization Disability Assessment Schedule II RA DAM 3 DATA SOURCES RA DAM COMPONENTS BY SOURCE Patient Lab Patient Lab Pain VAS Global Function (HAQ) ESR CRP Provider Provider Global Swollen Joint Count Tender Joint Count 2

RA DAM FINAL 6 DAMS Measure Scale RA DAM CUTOFFS Level of Disease Activity Patient PAS PAS-II RAPID-3 CDAI DAS-28 SDAI Lab Remission Low Medium High PAS 0-10 <0.25 <3.70 <8.

1+ DIFFERENCES IN PATIENT- REPORTED MEASURES All three use pain and patient global Difference only in functional assessment PAS uses HAQ RAPID-3 uses PAS-II uses HAQ-II THE HAQ

3 RA DAM FINAL 6 DAMS Measure Scale RA DAM CUTOFFS Level of Disease Activity Patient PAS PAS-II RAPID-3 CDAI DAS-28 SDAI Lab Remission Low Medium High PAS 0-10 <0.25 <3.70 < PAS-II 0-10 <0.25 <3.70 < RAPID < CDAI Provider SDAI DAS <2.6 < DIFFERENCES IN PATIENT- REPORTED MEASURES All three use pain and patient global Difference only in functional assessment PAS uses HAQ RAPID-3 uses PAS-II uses HAQ-II THE HAQ FAMILY A B R I E F V I S I T W I T H WHAT IS THE HAQ? Stanford (Health Assessment Questionnaire)Disability Index Jim Fries 20 Likert-questions 21 Aid/devices questions Designed to be a generic measure of function 3

4 WHICH TO USE FOR YOUR CLINIC? Depends on your clinic Laboratory measure - greatest limitation Provider measures? HAQ GOLD STANDARD WIDE RANGE OF FUNCTION THEN CAME MHAQ MHAQ Modified HAQ, Ted Pincus, 1983 Much shorter 8 questions: 1 from each of 8 dimensions of the HAQ 4

5 MHAQ THEN CAME MD-HAQ Multidimensional HAQ Ted Pincus, 1999 Added 2 new questions to the MHAQ Participate in Sports Walk 2 miles on flat ground HAQ-II Fred Wolfe, Kaleb Michaud (& Ted Pincus) questions, 5 from HAQ, 5 new Used IRT/Rasch analysis to develop Most efficient way of determining function score (using HAQ as standard), with least number of questions Better at distinguishing differences in function 5

HAQ-II THE RA HAQ FAMILY DIFFERENCES BETWEEN PATIENT-REPORTED RA DAMS All three use pain and patient global assessment Differences due to functional assessment PAS

are better at distinguishing differences in function (responsive) than MHAQ & If starting from scratch, PAS-II may be best, since it incorporates the HAQ-II - so

6 HAQ-II THE RA HAQ FAMILY DIFFERENCES BETWEEN PATIENT-REPORTED RA DAMS All three use pain and patient global assessment Differences due to functional assessment PAS uses HAQ RAPID3 uses PAS-II uses HAQ-II PAS, PAS-II, RAPID-3 HAQ FAMILY SUMMARY PROVIDER RA DAMS While all HAQs are valid measures of function, the HAQ & HAQ-II are better at distinguishing differences in function (responsive) than MHAQ & If starting from scratch, PAS-II may be best, since it incorporates the HAQ-II - so faster than full HAQ and potentially better at distinguishing changes in function. DAS-28 Hard to calculate DAS-28 = 0.56xSqrt(28TJC) xSqrt(28SJC) xln(ESR) xPatGlobal Remission may still have several swollen joints, specifically excludes small joints of the feet Lab components (esr, crp) may not be resulted before or at the enconuter when clinical decisions need to be made. CDAI (& SDAI) 28TJC + 28SJC + PrGlobal + PatGlobal (+CRP) SDAI 3.3 is ACR/EULAR remission criteria 6

7 CONCLUSIONS There is no ideal measure of disease activity Measures excluded in [this] review could later be found to possess... superior psychometric properties to the 6 recommended. Knowing the data source (patient, provider, lab), the subtleties of individual data elements, and overlaps between the measures is important to fully understand what you are actually measuring in a composite scoring system Computerized branching algorithmic measures (PROMIS) have the potential to break new ground in the field of composite disease activity measurement 7

Supplemental Table 1. Key Inclusion Criteria Inclusion Criterion OPTIMA PREMIER 18 years old with RA (per 1987 revised American College of General

Supplemental Table 1. Key Inclusion Criteria Inclusion Criterion OPTIMA PREMIER 18 years old with RA (per 1987 revised American College of General Rheumatology classification criteria) 34 ; erythrocyte