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Disease Activity Measurement in Clinical Practice Implementation of Clinical Measures in Patient Care Speaker, Degree, Meeting Date, Location Target Audience This CME activity is intended for practicing rheumatologists, whether in office based practice or academic based practice. There is no fee for participation in this CME activity. This program is made possible through educational grants from Bristol-Myers Squibb and Abbott Immunology Accreditation This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of CMEsolutions and Miller Professional Consulting. CMEsolutions is accredited by the ACCME to provide continuing medical education for physicians. CMEsolutions designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity. Disclosure of Significant Relationships with Relevant Commercial Interests Neither CMEsolutions nor Miller Professional Consulting has any commercial interests relevant to the content of this activity. The content of this CME activity will not contain discussion of off-label uses. Please consult the product prescribing information for full disclosure of labeled uses. CME Credit Statements To receive continuing education credit, please complete the evaluation and credit request form and submit following the meeting. Credit Statements will be mailed within two weeks of activity completion. Faculty Faculty Name and Degree Affiliation City and State Dr. XXXX’s Disclosure Statement indicates that she/he …: Dr. XXXX also discloses that there will/will not be discussion of off-label uses of any products during this presentation. Objectives After completing this activity attendees will be able to 1) Describe the utilization of clinical disease assessment tools used to measure disease activity in rheumatoid arthritis in clinical trials a. ACR scoring b. DAS c. EULAR 2) Describe and utilize patient based/derived measures of disease activity in rheumatoid arthritis and other rheumatologic conditions a. MHAQ b. RAPID 3,4,5 c. S-DAI d. C-DAI e. GAS 3) Describe the utilization of laboratory testing for measurement of disease activity in rheumatoid arthritis 4) Describe the utilization of imaging tools in assessing rheumatoid arthritis 5) Describe data on approaches to disease activity assessment utilized by their peers in the assessment of disease activity in clinical practice. Reasons to Assess/Measure Parameters in the Course of Managing Patients Assess prognosis Guide general approach to therapy Treatment decisions & changes Documentation – compare patient from visit to visit Gold Standard Measures Blood pressure Total cholesterol Creatinine Glucose- Hgb A1C INR ESR CCP DXA We can make a diagnosis or decide to implement or change treatment based upon these tests Rheumatology: No “Gold Standard” for Measuring Disease Activity • Laboratory tests • Imaging • Joint counts Limited Value Limited if any use for any one of these parameters alone as basis for making treatment decisions at each office visit Rheumatology: Requirements for a “Gold Standard” Reliable Accurate Validated Predictive Value Easily and quickly performed Information immediately accessible Harmless Inexpensive Evidence that Better Patient Outcomes May Be Achieved Using Disease Activity Measurement To Guide Treatment Decisions Disease activity measurement : demonstrated value in management of rheumatoid arthritis – TICORA Trial – BeST Trial May determine when patients may change/stop medications1 Van der Bijl AE, et al Arthritis Rheum 56 (7) 2007 Grigor C et al Lancet 364 (263-9( 2004 TICORA (Tight Control in RA) Study Design Single-blind RCT in RA patients with DAS > 2.4 (N=111) Intensive care protocol – Patients assessed monthly – After 3 mo, oral treatment escalated if DAS 2.4 at monthly assessment – Physicians were obligated to change therapy based on DAS results Routine care protocol – DMARD monotherapy in patients with active synovitis – Addition of 2nd DMARD at physician discretion – Patients assessed at 3-mo intervals with no formal composite measure of disease activity Endpoints – Primary outcome • Mean drop in DAS • Proportion of patients with good response (DAS < 2.4 and drop in score from baseline by > 1.2) – Secondary outcome measures • Proportion of patients in remission (DAS < 1.6) • Modified TSS at 18 mo Grigor C, et al. Lancet. 2004;364:263-269. TICORA Clinical Response 100% 80% Intensive Group (n=55) Routine Group (n=56) 60% 40% 20% R E EU LA R Grigor C,et al. Lancet 2004; 364:263-269 A C R 70 A C R 50 A C R 20 EU LA R G M IS S O IO O N D 0% Intensive Treatment Resulted in Better Disease Response DAS Scores Intensive group (n=53) 6 Disease Activity Score Routine group (n=50) 5 4 3 2 1 0 0 3 6 9 Month 12 P <0.0001, Intensive vs Routine after month 3. Grigor C, et al. Lancet. 2004;364:263-269. 15 18 Intensive Treatment Resulted in Better Radiologic Scores Intensive group (n=53) Routine group (n=50) P values Erosion score 0.5 3 0.002 Joint space narrowing 3.25 4.5 0.331 Total Sharp score 4.5 8.5 0.02 Median parameter Grigor C, et al. Lancet. 2004;364:263-269. BeSt Trial Study Design Study design: multicenter, randomized, single-blind, intent-to-treat (ITT) analysis Objective: evaluate clinical and radiologic outcomes after 1 year N=508 patients with early RA (<2 years by ACR criteria) – DMARD naïve – Baseline demographics similar in all 4 groups De Vries-Bouwstra JK, et al. ACR 67th Annual Meeting; 2003. Abstract: #LB18. De Vries-Bouwstra. EULAR 2004 abstract OP0103. BeSt Trial Protocol/Groups Protocol/Groups – Group 1 (n=125): Sequential monotherapy: MTX up to 25 mg/weekSSZ leflunomide – Group 2 (n=122): Step-up therapy from MTX add SSZ add hydroxychloroquine – Group 3 (n=133): Step-down therapy from MTX + SSZ + prednisone 60 mg tapered to 7.5 mg (Initial COBRA Combination) – Group 4 (n=128): Treatment with MTX (7.5 mg/wk for 2 weeks, then 15 mg/wk) and infliximab (3 mg/kg at week 0, 2, and 6, then every 8 weeks), doses increased or reduced to zero depending on DAS Change in treatment protocol dictated by 3 monthly determinations of DAS with goal of DAS ≤ 2.4 – If DAS > 2.4, next step in protocol – If DAS ≤ 2.4, maintain or taper, according to protocol De Vries-Bouwstra JK, et al. ACR 67th Annual Meeting; 2003. Abstract: #LB18. De Vries-Bouwstra. EULAR 2004 abstract OP0103. Patients in Remission* % of Patients 80 70 Mono 60 Step-up All patients discontinued infliximab at month 9 Combo 50 Anti-TNF 40 30 20 10 0 0 3 6 Month *Remission indicates DAS < 2.4. De Vries-Bouwstra JK, et al. Ann Rheum Dis; 2004;63(1):58. 9 12 Outcome in “5th” BeSt group – 1 year Routine Care (n=201): Early RA patients from Dutch clinics meeting BeSt criteria DAS-driven Therapy (n=234): Groups 1 and 2 from BeSt trial – those on conventional therapy and not biologics 1-year assessment HAQ ΔDAS28 ESR Routine Care DAS-driven Therapy P-value 0.9 0.7 -1.9 19 (6 to 37) 0.7 0.7 -2.7 13 (3 to 28) 0.029 <0.001 0.011 • Conclusion: Intensive therapy achieves better outcomes than routine care Goekoop-Ruiterman YPM, et al. ACR, Washington DC 2006, #843 Consistent Use of Measurement Tools: Better Practice Outcomes Requirements for recording/reporting of defined measures by 3rd parties – Quality Initiatives – P4P – Pre-authorization, renewal of approval Use of consistent measurement improves documentation, and the ability to justify billing codes and procedures Van der Bijl AE, et al Arthritis Rheum 56 (7) 2007 Monitoring of RA Care Informal Surveys of Rheumatologists How often do you perform in practice? – Focused joint exam >90% – Scored 28 joint exam <20% – HAQ (any version) 10-15% – DAS (any version) <2% – Annual radiographs <10% Courtesy—Jack Cush, MD How Do You Assess Efficacy and Need for Ongoing TNF Inhibitor Therapy? Response Mean Physician joint exam Patient assessment of response Drug tolerability Physician global assessment Radiographic assessments ESR or CRP Functional outcome measures Disease activity score (DAS) 1.69 1.88 2.04 2.14 2.94 3.18 4.20 5.41 *Importance Ranked (1-7); from most important (1) to never important (7) (n=880) Cush JJ. Ann Rheum Dis. 2005 Nov;64 Suppl 4:iv18-23 How do you Monitor Response/Safety to TNFi in RA Frequently done (>66%) 96% Vital signs 81% CBC, ESR 88% AM stiffness 83% MD overall assessment 75% Joint exam (Pt focused) 68% CRP Seldom done (<33%) Often done (>33<66%) 59% PPD 54% LFTs 52% CRP 51% Yearly hand X-rays 39,51% Pt Global, Pt Pain 39% Symptom survey 33% MD Global Assessment 27% 28 Joint count 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 vers.) Cush JJ. Ann Rheum Dis. 2005 Nov;64 Suppl 4:iv18-23 Measuring Up: Chronic Disorders and Assessment Standards Gestalt Rheumatoid arthritis* Osteoarthritis* Ankylosing spondylitis* Vasculitis* Psoriasis* Multiple sclerosis* Crohn’s disease* Quantitative Osteoporosis Gout Lupus Myositis COPD/Asthma NIDDM HIV CHF HTN * Objective validated outcome measures exist for RCT; seldom done in practice Patient Assessment Physician Global Assessment: Gestalt Formal Joint Counts Lab/Imaging results – Biomarkers Categorical Outcomes Measures – ACR* Continuous Measurement Tools – Health Assessment Questionnaire (HAQ)* – Disease Activity Score (DAS)* – Simplified Disease Activity Index (SDAI)* – Clinical Disease Activity Index (CDAI)* – Global Arthritis Score (GAS)* – Routine Assessment of Patient Index Data (RAPID)* * Contain patient reported outcome measures Gestalt: Merriam Webster Definition Gestalt: a structure, configuration, or pattern of physical, biological, or psychological phenomena so integrated as to constitute a functional unit with properties not derivable by summation of its parts Gestalt is not a metric – it cannot be used to measure anything in a way that can be communicated objectively to another scientist www.merriam webster.com Problems with Gestalt as Physician Global Although high in “efficiency”, Gestalt described as “doing better” or “doing worse” or “doing a lot better” or “doing a lot worse” is considered arbitrary by third party payers No standardization Should be recorded at every visit –but Gestalt cannot be quantified Assessing Outcomes Gestalt Metrics: DAS, ACR, RAPID, – Inter and intra observer variation – Not reproducible – Can be tracked and graphed – Hard to track – High inter and intra observer reliability – Imprecise – “The RAPID 5 improved, dropping from S and C DAI, GAS, etc • My patient is doing well 4 to 1” • My patient isn’t doing very well – OK when we really did not want to know exactly how our patients were doing – Now that we might be able to achieve remission, metrics become important – If we measure, we find many patients are doing measurably better – We also identify those whose progress does not measure up and who need management changes Formal Joint Counts in Patient Management Most specific measure to assess RA Most important measure in clinical trials 28-joint count as useful in clinical trials as 68–70 joint counts Limitations of Formal Joint Counts Joint counts may improve over 5 years while progressive joint damage and functional disability may occur * Joint counts have similar or lower relative efficiencies than global and patient measures to document differences between active and control treatments in clinical trials ** * Arthritis Care Res 10:381-394, 1997 ** Arthritis Rheum 48:625-630, 2003. Arthritis Rheum 52:1031-1036, 2005. J Rheumatol 33:2146-2152, 2006, Rheumatology Limitations of Formal Joint Counts Joint counts are poorly reproducible* Rheumatologists perform careful non-quantitative joint examination, but not formal joint count, at most visits in usual care** *Lewis et al. Br J Rheumatol 1988; 27:32. Hart et al. J Rheumatol 1985; 12:716. Klinkhoff et al. J Rheumatol 1988; 15:492. Thompson et al. J Rheumatol 1991; 18:661. Kvien et al. Ann Rheum Dis 2005; 64:1480. Scott DL et al. 2006; 15:579. **Pincus and Segurado, Ann Rheum Dis 65:820-822, 2006 Question for Rheumatologists “For patients with RA under your care (not including patients in clinical trials), how often do you perform formal tender and swollen joint counts?” Never 13% 1–24% of visits 25–49% of visits 50–74% of visits 75–99% of visits Always 32% 11% 14% 16% 14% Pincus and Segurado, Ann Rheum Dis 65:820-822,2006. Imaging in Management of RA Excellent quantitative x-ray scoring systems - Sharp, van der Heijde, Larsen, Genant Reflect cumulative damage of disease Aid in evaluating treatment response and decision making Imaging Concerns X-ray may be too insensitive to change in structure MRI may find changes earlier than X-ray – Active field of investigation to define significance of findings – MRI Changes may be predictive of long term outcomes Ultrasound – – Image surface but not deeper erosions – Image synovitis – Generally accepted quantifiable measures for assessing disease progression not yet in place – Learning curve Current studies not always available at visit – In office access for x-ray- widespread – In office access to ultrasound and MRI- limited – Performed at multiple referral sites 2nd to payer requirementslimits side by side comparisons Laboratory Tests in Management Rheumatoid Factor(RF) and Anti-CCP diagnostic value ESR; CRP – reflect inflammation, – can be discordant and may not always correlate with one another CBC, Chemistries- reflect systemic manifestations of disease and treatment adverse reactions CCP = cyclic citrullinated proteins. Limitations of Laboratory Testing ESR, CRP normal in 40% at presentation Anti-CCP & RF negative in 20-50% of patients Positive tests: reassuring Negative tests: – do not exclude diagnosis of RA – do not invariably obviate or exclude need for more aggressive therapies Current laboratory values are not always available at visit Quality a concern – if ESR not done stat but delayed (as could happen if sent to central reference lab) accuracy and reliability diminished Measurement Tools ACR20 Pt Function Pt Pain Pt Global MD Global TJC DAS28 SDAI CDAI SJC ESR or CRP ESR CRP GAS RAPID* (5) *RAPID – Three Options – RAPID 3; RAPID 4; RAPID 5 ** RADAI- information provided entirely by patient (4)** ACR Core Data Set SJC TJC Physician Global Assessment ESR or CRP Physical Function (HAQ, MHAQ, MDHAQ) Pain Patient Global Assessment Radiographs ACR 20, 50, 70 Categorical- 20%, 50% or 70% response in core data set measures – Not a continuous measure Designed for comparing treatments, response “Change score” not “activity score” ACR N? Hybrid ACR? Disease Activity Score-28 Joints (DAS28) DAS28 = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 • • • • TJC=Tender Joint Count SJC=Swollen Joint Count ESR=mm/hr CRP=mg/l GH=Patient Global Health Visual Analog (0-100mm) High Disease Activity>5.1; Low Activity<3.2; Remission<2.6 Available at www. DAS-score.nl The DAS and DAS28 are not directly interchangeable! DAS28=1.072(DAS)+0.938 Prevoo ML, et al. Arthritis Rheum 1995; 38: 44-48; www.das-score.nl DAS-44 DAS – Ritchie articular index (0-78) – SJC (0-44) – ESR – Global assessment of disease activity • ≤2.4 = low • 2.4<DAS ≤3.7 = moderate • >3.7 = high – DAS < 1.6 remission EULAR response criteria Current DAS28: Current DAS DAS28 < 3.2 Reduction of DAS28: >1.2 >0.6 and < 1.2 < 0.6 DAS < 2.4 good moderate none 3.2 < DAS28 < 5.1 2.4 < DAS28 < 3.7 moderate moderate none DAS28 > 5.1 DAS28 > 3.7 moderate none none Van Gestel et al. Arthritis Rheum. 1998;41(10):1845-50. DAS Limitations: Requires Laboratory Tests and Computation Current lab tests required for calculation often unavailable at time when DAS needed if to be considered in management DAS calculation requires use of specifically designed calculator or formula available on line – Perceived to be time consuming Simplified Disease Activity Index SDAI Tender joint count (0-28) Swollen joint count (0-28) Patient Global Assessment (0-10) Physician Global Assessment (0-10) CRP (mg/dl) >26 High disease activity 11-26 Moderate disease <11 Mild disease <3.3 Remission Clin Exp Rheumatol 2005; 23 (Suppl. 39):S100-S108. Simplified Disease Activity Index SDAI Tender joint count >26 High disease (0-28) activity Swollen joint count 11-26 Moderate (0-28) disease Patient Global <11 Mild disease Assessment (0-10) <3.3 Remission Physician Global Assessment (0-10) CRP (mg/dl) Requires formal joint count and laboratory test Clin Exp Rheumatol 2005; 23 (Suppl. 39):S100-S108. Clinical Disease Activity Index CDAI Tender joint count (0-28) Swollen joint count (0-28) Patient Global Assessment (0-10) Physician Global Assessment (0-10) – Eliminates ESR/CRP Aletaha and Smolen Clin Exp Rheumatol 23:S100, 2005. Clinical Disease Activity Index CDAI Tender joint count (0-28) Swollen joint count (0-28) Patient Global Assessment (0-10) Physician Global Assessment (0-10) – Eliminates ESR/CRP – Still requires formal joint count Aletaha and Smolen Clin Exp Rheumatol 23:S100, 2005. CDAI Categories – Activity Level Aletaha and Smolen, 2005 Level Interpretation 0-2.8 = Remission – therapy is working 2.81–10 = Low - ?? change therapy 10.1–22 = Moderate – consider strongly change in therapy 22-76 = High - change therapy or have a good reason not to do so SDAI and CDAI Advantages and Disadvantages Relatively easy to calculate SDAI requires formal joint counts and laboratory test CDAI requires formal joint counts Disease Activity Measures Based Upon Patient Reported Data Requirements for Measurement Tools Incorporating Patient Reports Validated –reflects disease activity and predicts outcomes Reliable Feasible – easily completed by patient – focus on major concerns of the patient Saves time for patient and health professional Clinically useful – available for review by MD prior to seeing patient –that day Acceptable to MD and patient Amenable to flow sheet charting Recognize under-appreciated disease severity and patient concerns 9- to 10-Year Survival According to Quantitative Markers in Three Chronic Diseases Pincus T,Callafan LF J Rheumatol 1990:17:1582-585;PincusT,Callahan LF. J Rheumatol 1989:18(S79):67-96;PincusT, Callahan LF, Vaugh WK J Rheumatol 1987: 14:240-251 A Rheumatoid Arthritis – Activities of Daily Living B 100 >90% 81%–90% 80 % Active “With Ease” 60 40 71%–80% Survival (%) Survival (%) 100 Rheumatoid Arthritis – Formal Education Level 70% 20 >12 Years 80 9–12 Years 60 8 Years 40 20 Months 0 40 60 80 100 0 D 100 Stage I 80 60 Stage II All Stages, All Causes Stage III Stage IV 40 Hodgkin Disease Anatomic Stage 20 Survival (%) Survival (%) C 20 Months 20 40 60 80 100 100 Coronary Artery Disease # Involved Vessels 80 1 Artery 60 2 Arteries 40 3 Arteries LCA 20 Years 0 2 4 6 8 10 Years 0 2 4 6 8 10 MDHAQ: Multi-Dimensional Health Assessment Questionnaire 5 scales rated 0-10: – ADL – Psychological status – Pain – Fatigue – Global status HAQ and Multidimensional HAQ (MDHAQ) HAQ 1st report Patient completion No. ADL Pain VAS Pt Global VAS Psych, sleep RADAI self-report joint count Fatigue Review of systems Medical history Demographic data Social history Scoring templates Index MD scan (“eyeball”) Time to score 1980 5–10 min 20 10 cm line 10 cm line No No No No No No No No No 30 secs 40 secs MDHAQ 1999 5–10 min 10 21 circles 21 circles Sleep, anxiety, depression Yes VAS 60 symptoms Surgery, side effects Yes Yes Yes RAPID 5 secs 10 secs HAQ or MDHAQ: High Predictive Value in RA • Functional status • Work disability • Costs • Joint replacement surgery • Death Pincus et al. Arthritis Rheum. 1984, Wolfe et al. J Rheumatol. 1991 Borg et al. J Rheumatol 1991, Callahan et al. J Clin Epidemiol. 1992, Wolfe and Hawley. J Rheumatol. 1998, Fex et al. J Rheumatol 1998, Sokka et al. J Rheumatol 1999, Barrett et al. Rheumatology 2000, Puolakka et al. Ann Rheum Dis 64:130-133, 2005 ) Lubeck et al. Arthritis Rheum. 1986 Wolfe and Zwillich. Arthritis Rheum. 1998 Pincus et al. Arthritis Rheum. 1984, Ann Intern Med.1994, Wolfe et al. J Rheumatol 1988, Leigh&Fries J Rheumatol 1991, Wolfe et al. Arthritis Rheum. 1994, Callahan et al. Arthrits Care Res 1996, 1997, Soderlin et al. J Rheumatol 1998, Maiden et al. Ann Rheum Dis 1999, Sokka et al. Ann Rheum Dis 2004) Global Arthritis Score Easily and rapidly obtained at office visits Correlates with DAS28, SDAI and CDAI – Remission ≤3 – Near-remission ≤7 – No value established for high activity Validated in small group practice and large database (CORRONA) Cush J, et al. ACR, San Diego 2005, #1854 GAS Patient pain (0–10) Raw mHAQ (0–24) TJC (0–28) Total 0–62 What Jack Uses One-Page Pt Self-Report Form Global Assessment Mark or Circle the Joint Pain That Hurts Morning Stiffness Quality of Sleep Comorbities Review of Systems Joint Pain Pain ADL - mHAQ Work/disability PCP, Health, Exercise Courtesy of Jack Cush MD. Global Arthritis Score (GAS): A Quick Practice Tool for RA Assessment GAS = TJC (0-28) + Pt Pain (0-10 VAS) + raw mHAQ (0-24) GAS mHAQ GAS vs. DAS28 R =0.88 SJC 60 DAS28 0.88 0.80 0.59 0.63 0.77 SDAI 0.93 0.71 0.78 CDAI 0.90 0.62 0.81 40 GAS GAS 50 30 20 10 0 -100.02 -20 2.02 4.02 6.02 8.02 DAS-28 GAS Performance (Spearman Rank Correlations) 64 patients; 244 visits J. Cush, MD ACR 2005 GAS in Practice No time No cost 9 Finger addition Better documentation One number/measure tracking (flow chart) Easier communication w/ NP, PA, Colleagues Data (metric) driven treatment changes Utility in OA, FM, PsA, Gout, PMR (not AS, SLE) Routine Assessment of Patient Index Data (RAPID) Mean of the composite score: – RAPID 3 • MDHAQ (0-10) • Patient Pain VAS (0-10) • Patient Global Assessment VAS (0-10) – RAPID 4 • Adds Patient Reported Joint Count (RADAI) (0-10) – RAPID 5 • Adds Physician Global Assessment (0-10) Converts Gestalt into a number! Pincus T, Yazici Y, Bergman M; JRheum. 2006; 33: 448 Pincus, T, et al. Clin Exp Rheum. 2006; 24: S60 RAPID 3 Scoring Categories Proposed RAPID 3 Categories Based Upon RAPID 3 Raw Score Range 0 - 30 <3.0 = Near Remission – therapy is working 3.01–6 = Low Severity – begin to consider change therapy 6.01–12.0 = Moderate Severity – consider strongly change in therapy >12.0 = High Severity – change therapy or have a good reason not to do so The minimally significant change = 3 units. Studies that provide validation for these categories have been submitted for publication RAPID Scoring The RAPID 3 score range is 0 – 30 The RAPID 4 score range is 0 – 40 The RAPID 5 score range is 0 – 50 To bring all RAPID scores into compliance with the suggested disease activity severity scoring categories, the RAPID 4 and RAPID 5 may be converted as follows: – RAPID 4 - divide raw score by 4 and then multiply by 3 – RAPID 5 - divide raw score by 5 and then multiply by 3 Possible RAPID 4 Scoring Categories Proposed RAPID 4 Categories Based Upon RAPID 4 Raw Score 0 - 40 <4.0 = Near Remission – therapy is working 4.01–8 = Low Severity – begin to consider change therapy 8.01–16.0 = Moderate Severity – consider strongly change in therapy >16.0 = High Severity – change therapy or have a good reason not to do so The minimally significant change = 4 units. Studies that provide validation for these categories have been submitted for publication Possible RAPID 5 Scoring Categories Proposed RAPID 5 Categories Based Upon RAPID 5 Raw Score 0 - 50 <5.0 = Near Remission – therapy is working 5.01–10 = Low Severity – begin to consider change therapy 10.01–20.0 = Moderate Severity – consider strongly change in therapy >20.0 = High Severity – change therapy or have a good reason not to do so The minimally significant change = 5 units. Studies that provide validation for these categories have been submitted for publication Spearman Correlation Coefficients in 274 Patients with RA – All p<0.001 (#) = Number of identical measures Measure DASvs CDAI vs CDAI 0.84 (3) --- RAPID3 0.66 (1) 0.74 (1) RAPID4PTJC 0.65 (1) 0.74 (1) RAPID4MDJC 0.73 (3) 0.83 (3) RAPID 5 0.69 (1) 0.80 (2) All results, P <0.001 DAS vs RAPID in AIM Abatacept Trial DAS28 RAPID2 RAPID3 RAPID 4-MD RAPID 4-JC RAPID5 Mean Change ( % ) 0% -10% -20% -30% -21% -25% -28% -27% -30% -32% Control Abatacept -40% -43% -47% -50% -54% -60% -52% -56% -61% -70% Pincus , Maclean, Hines, Bergman, Yazici,. EULAR. 2007 RAPID can be calculated from data used to calculate DAS Number of Patients in Remission at Conclusion of 4 Adalimumab Trials According to DAS28, CDAI, RAPID3, RAPID5 160 140 120 100 ADA PBO 80 60 40 20 0 DAS28 Pincus, Amara, Segurado, Bergman, Koch et al ACR 2007 CDAI RAPID3 RAPID5 RAPID can be calculated from data used to calculate DAS Resistance to Questionnaires What are the 3 most important resistance points when implementing patient questionnaires in standard clinical care? Responses of about 600 rheumatologists on keypads at a meeting to introduce adalimumab to the European market. Data concerning 3 responses normalized to 100%. __________________________________________________________ Response Option Takes too much time Staff will not cooperate Patient will not cooperate No experience – never tried Don’t know how to interpret results Measures do not change enough to be helpful Patient results are not valid results % 87 63 39 36 33 24 18 Pincus T, Yazici Y, Bergman M, JRheumatol; 2006, 33(3): 448-454 Incorporating Measures into Practice Commitment to collecting data – Must be useful – Must be consistently and rapidly obtained – Must not interfere with the flow of the practice – Must be accessible for review during the visit The “Ten Commandments” of Questionnaires Use a questionnaire designed for clinical practice, not research Include “constant” and “variable” fields Orient the staff to the importance of collecting the data Complete the questionnaire at every visit Complete the questionnaire in the waiting room The “Ten Commandments” of Questionnaires Have the patient complete the questionnaire, not the staff Review the results at each visit in front of the patient Score the results – Templates help in scoring Use flow sheets or graphs to track results Store the results for future reference – Technology helps, but is not essential Pincus T, Yazici Y, Bergman M, JRheumatol; 2006, 33(3): 448-454 Using Clinical Data Regardless of how it is obtained, Clinical data must be reviewed to be useful Therapy should be adjusted based on measured responses – DAS28<3.2 or DAS < 2.4 – SDAI<22 – GAS<7 – RAPID<2 It Takes Very Little Time to Complete a Patient Report Based Disease Activity Measure Seconds Mean Time to Score Pincus T, et al. Abstract #1764 ACR Washington DC 2006 RAPID 3 Rheumatoid Arthritis Disease Activity Index RADAI Self-Report Joint Count: Fourth Component for RAPID 4 3. Please place a check (√) in the appropriate spot to indicate the amount of pain you are having today in each of the joint areas listed below: None Mild Moderate Severe None a.LEFT FINGERS b.LEFT WRIST c.LEFT ELBOW d.LEFT SHOULDER e.LEFT HIP f.LEFT KNEE g.LEFT ANKLE h.LEFT TOES i.RIGHT FINGERS j.RIGHT WRIST k.RIGHT ELBOW l.RIGHT SHOULDER m.RIGHT HIP n.RIGHT KNEE o.RIGHT ANKLE p.RIGHT TOES q.NECK r.BACK Stucki G et al. Arthritis Rheum. 1995;38:795-798. Mild Moderate Severe RAPID5 Multidimensional Health Assessment Questionnaire (MDHAQ) YOUR NAME:______________________________ Date of Birth: _______________ Today’s Date:______________ 1. OVER THE PAST WEEK, were you able to: Without ANY difficulty □ □ □ □ □ □ □ □ □ □ Dress yourself, including tying shoelaces, doing buttons? Get in and out of bed? Lift a full cup or glass to your mouth? Walk outdoors on flat ground? Wash and dry your entire body? Bend down to pick up clothing from the floor? Turn regular faucets on and off? Get in and out of a car, bus, train, or airplane? Walk two miles? Participate in sports and games as you would like? 2. □ □ □ □ □ □ □ □ □ □ 0 0 0 0 0 0 0 0 0 0 With MUCH difficulty □ □ □ □ □ □ □ □ □ □ 1 1 1 1 1 1 1 1 1 1 UNABLE to do 2 2 2 2 2 2 2 2 2 2 □ □ □ □ □ □ □ □ □ □ 3 3 3 3 3 3 3 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 8 8.5 9 9.5 None Mild □0 □0 □0 □0 □0 □0 □0 □0 □0 Moderate Severe □1 □1 □1 □1 □1 □1 □1 □1 □1 □2 □2 □2 □2 □2 □2 □2 □2 □2 3 RAPID3 0-30 □1 □1 □1 □1 □1 □1 □1 □1 □1 Moderate □2 □2 □2 □2 □2 □2 □2 □2 □2 Severe □3 □3 □3 □3 □3 □3 □3 □3 □3 Considering all the ways in which illness and health conditions may affect you at this time, please indicate below how you are doing: VERY WELL 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 8 8.5 9 9.5 PTGL 0-10 JT CT 0-10 Mild □0 □0 □0 □0 □0 □0 □0 □0 □0 RIGHT FINGERS RIGHT WRIST RIGHT ELBOW RIGHT SHOULDER RIGHT HIP RIGHT KNEE RIGHT ANKLE RIGHT TOES BACK PN 0-10 3 10 None □3 □3 □3 □3 □3 □3 □3 □3 □3 16=5.3 17=5.7 18=6.0 19=6.3 20=6.7 21=7.0 22=7.3 23=7.7 24=8.0 25=8.3 26=8.7 27=9.0 28=9.3 29=9.7 30=10 3 Please place a check (√) in the appropriate spot to indicate the amount of pain you are having today in each of the joint areas listed below: LEFT FINGERS LEFT WRIST LEFT ELBOW LEFT SHOULDER LEFT HIP LEFT KNEE LEFT ANKLE LEFT TOES NECK 1=0.3 2=0.7 3=1.0 4=1.3 5=1.7 6=2.0 7=2.3 8=2.7 9=3.0 10=3.3 11=3.7 12=4.0 13=4.3 14=4.7 15=5.0 PAIN AS BAD AS IT COULD BE 0 4. With SOME difficulty How much pain have you had because of your condition OVER THE PAST WEEK? Please indicate below how severe your pain has been: NO PAIN 3. FN 0-10 Please check () the ONE best answer for your abilities at this time: 10 VERY POORLY 1=0.2 2=0.4 3=0.6 4=0.8 5=1.0 6=1.3 7=1.5 8=1.7 9=1.9 10=2.1 11=2.3 12=2.5 13=2.7 14=2.9 15=3.1 16=3.3 17=3.5 18=3.8 19=4.0 20=4.2 21=4.4 22=4.6 23=4.8 24=5.0 25=5.2 26=5.4 27=5.6 28=5.8 29=6.0 30=6.3 31=6.4 32=6.7 33=6.9 34=7.1 35=7.3 36=7.5 37=7.7 38=7.9 39=8.1 40=8.3 41=8.5 42=8.8 43=9.0 44=9.2 45=9.4 46=9.6 47=9.8 48=10 RAPID4 0-40 DO NOT WRITE BELOW THIS – FOR DOCTOR’S USE ONLY – MD Global VERY WELL 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 8 8.5 9 9.5 VERY POORLY MDGL:0-10 10 RAPID5 0-50 The Short Distance From Where We Are To Where We Need To Go Survey 138 conducted Spring 2007 Surveys Analyzed Survey 2007 Item Yes Swollen Joint Count* 97% Tender Joint Count* 97% Morning Stiffness 93% Medications 91% Pain* 88% ESR 86% Physician Global Assessment* 81% CRP 79% Fatigue 77% Physical exam other than joint exam 76% Do you record pain on range of motion 75% Gestalt 70% Patient Global* 67% Do you record a numerical value for any variable 49% *Parameters used to calculate RAPID Survey 2007 Results of radiographs 39% HAQ 34% Is your Gestalt the same for each patient? 31% MRI 17% MHAQ 12% Ultrasound 7% RAPID 7% MD HAQ functional score 6% DAS 28 ( CRP or ESR) 6% ACR Score 4% Ritchie Articular Index 3% GAS 3% SDAI 1% CDAI 0% We are Very Close: Frequently Measured Parameters that are Included in the RAPID Item Yes Swollen Joint Count 97% Tender Joint Count 97% Pain 88% Physician Global Assessment 81% Patient Global 67% Exercise habits 49% Depression and anxiety 47% Strength 47% Disability status 41% Benefits of Using Patient Reported Measures Standardization enhances consistent data collection Better reimbursement (level 4,5) – Review your charts with coding expert – Custom design your office visit template incorporating data from PRO – Patient entered data can be counted in coding process Pay for Performance Numeric Flow Charts allow for facile justification of Rx decisions by 3rd party payers Benefits of Using Patient Reported Measurements Better use of waiting room time- patient completes forms while waiting Replace patient list of symptoms and issues with preformatted list that “talks to physician” Provides for consistent data collection Append serial PROs to treatment authorization requests- answers payer question of “what is the patient’s ACR score?” Benefits of Using Patient Reported Measures Patient does most of workMD time minimal Numerical surrogate for response to management Focuses visit Serial results support management decisions Physician chooses measurement tool Consistent recording of information from visit to visit – Important for each physician – Important for communication between physicians – – Saves time Avoids wandering discussion Reminds patient of variables they may not remember Objective documentation of patient status in patient’s own hand Limitations of Patient Self-Report Questionnaires 1. Need for translation –language issues 2. Cultural and linguistic issues 3. Possibility of “gaming” by patient, health professional to provide desired responses 4. Not specific to any disease Answers to Objections Takes too much time Staff will not cooperate Patient will not cooperate No experience – never tried Don’t know how to interpret results Measures do not change enough to be helpful Patient results are not valid results Takes 20 seconds and helps to focus visit Will staff decline to do vital signs? Make a DAM a vital sign Patients positive about completing form- helps them remember See one, do one, teach one You have seen suggested use of scoring which you will enhance with experience Measures do change Patient reported measures generate valid results Conclusions Patient Outcome Measures are of significant utility to the patient and to the physician Utilization requires a commitment on the part of the physician Data acquisition should be routine and performed on every patient, at every visit Once obtained, the data should help “drive” decision-making Patient collected data is reliable, correlates with other established measures and IS MOSTLY DONE BY THE PATIENT, THUS SAVING TIME FOR THE HEALTHCARE TEAM WITHOUT COMPROMISING DATA CREDIABILITY! Examples of Forms RAPID5 Multidimensional Health Assessment Questionnaire (MDHAQ) YOUR NAME:______________________________ Date of Birth: _______________ Today’s Date:______________ 1. OVER THE PAST WEEK, were you able to: Without ANY difficulty Get in and out of bed? Lift a full cup or glass to your mouth? Walk outdoors on flat ground? Wash and dry your entire body? Bend down to pick up clothing from the floor? Turn regular faucets on and off? Get in and out of a car, bus, train, or airplane? Walk two miles? Participate in sports and games as you would like? □1 □1 □1 □1 □1 □1 □1 □1 □1 □1 UNABLE to do □2 □2 □2 □2 □2 □2 □2 □2 □2 □2 □3 □3 □3 □3 □3 □3 □3 □3 □3 □3 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 8 8.5 9 None Mild □0 □0 □0 □0 □0 □0 □0 □0 □0 Moderate Severe □1 □1 □1 □1 □1 □1 □1 □1 □1 □2 □2 □2 □2 □2 □2 □2 □2 □2 □0 □0 □0 □0 □0 □0 □0 □0 □0 RIGHT FINGERS RIGHT WRIST RIGHT ELBOW RIGHT SHOULDER RIGHT HIP RIGHT KNEE RIGHT ANKLE RIGHT TOES BACK Mild □1 □1 □1 □1 □1 □1 □1 □1 □1 Moderate □2 □2 □2 □2 □2 □2 □2 □2 □2 Severe □3 □3 □3 □3 □3 □3 □3 □3 □3 Considering all the ways in which illness and health conditions may affect you at this time, please indicate below how you are doing: VERY WELL 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 8 8.5 9 PN 0-10 PTGL 0-10 JT CT 0-10 9.5 10 None □3 □3 □3 □3 □3 □3 □3 □3 □3 16=5.3 17=5.7 18=6.0 19=6.3 20=6.7 21=7.0 22=7.3 23=7.7 24=8.0 25=8.3 26=8.7 27=9.0 28=9.3 29=9.7 30=10 RAPID3 0-30 Please place a check (√) in the appropriate spot to indicate the amount of pain you are having today in each of the joint areas listed below: LEFT FINGERS LEFT WRIST LEFT ELBOW LEFT SHOULDER LEFT HIP LEFT KNEE LEFT ANKLE LEFT TOES NECK 1=0.3 2=0.7 3=1.0 4=1.3 5=1.7 6=2.0 7=2.3 8=2.7 9=3.0 10=3.3 11=3.7 12=4.0 13=4.3 14=4.7 15=5.0 PAIN AS BAD AS IT COULD BE 0 4. With MUCH difficulty How much pain have you had because of your condition OVER THE PAST WEEK? Please indicate below how severe your pain has been: NO PAIN 3. With SOME difficulty □0 □0 □0 □0 □0 □0 □0 □0 □0 □0 Dress yourself, including tying shoelaces, doing buttons? 2. FN 0-10 Please check () the ONE best answer for your abilities at this time: 9.5 10 VERY POORLY 1=0.2 2=0.4 3=0.6 4=0.8 5=1.0 6=1.3 7=1.5 8=1.7 9=1.9 10=2.1 11=2.3 12=2.5 13=2.7 14=2.9 15=3.1 16=3.3 17=3.5 18=3.8 19=4.0 20=4.2 21=4.4 22=4.6 23=4.8 24=5.0 25=5.2 26=5.4 27=5.6 28=5.8 29=6.0 30=6.3 31=6.4 32=6.7 33=6.9 34=7.1 35=7.3 36=7.5 37=7.7 38=7.9 39=8.1 40=8.3 41=8.5 42=8.8 43=9.0 44=9.2 45=9.4 46=9.6 47=9.8 48=10 RAPID4 0-40 DO NOT WRITE BELOW THIS – FOR DOCTOR’S USE ONLY – MD Global VERY WELL 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 5.5 6 6.5 7 7.5 8 8.5 9 VERY POORLY MDGL:0-10 9.5 10 RAPID5 0-50 5. Please check (√) if you have experienced any of the following over the last month: __ Fever __ Lump in your throat __ Paralysis of arms or legs __ Weight gain (>10 lbs) __ Cough __ Numbness or tingling of arms or legs __ Weight loss (<10 lbs) __ Shortness of breath __ Fainting spells __ Feeling sickly __ Wheezing __ Swelling of hands __ Headaches __ Pain in the chest __ Swelling of ankles __ Unusual fatigue __ Heart pounding (palpitations) __ Swelling in other joints __ Swollen glands __ Trouble swallowing __ Joint pain __ Loss of appetite __ Heartburn or stomach gas __ Back pain __ Skin rash or hives __ Stomach pain or cramps __ Neck pain __ Unusual bruising or bleeding __ Nausea __ Use of drugs not sold in stores __ Other skin problems __ Vomiting __ Smoking cigarettes __ Loss of hair __ Constipation __ More than 2 alcoholic drinks per day __ Dry eyes __ Diarrhea __ Depression - feeling blue __ Other eye problems __ Dark or bloody stools __ Anxiety - feeling nervous __ Problems with hearing __ Problems with urination __ Problems with thinking __ Ringing in the ears __ Gynecological (female) problems __ Problems with memory __ Stuffy nose __ Dizziness __ Problems with sleeping __ Sores in the mouth __ Losing your balance __ Sexual problems __ Dry mouth __ Muscle pain, aches, or cramps __ Burning in sex organs __ Problems with smell or taste __ Muscle weakness __ Problems with social activities 6. When you awakened in the morning OVER THE LAST WEEK, did you feel stiff? �No �Yes If “No,” please go to Item 7. If “Yes,” please indicate the number of minutes_______, or hours _____ until you are as limber as you will be for the day. 7. How do you feel TODAY compared to ONE WEEK AGO? Please check (�) only one. Much Better � (1), Better � (2), the Same � (3), Worse � (4), Much Worse � (5) than one week ago 8. How often do you exercise aerobically (sweating, increased heart rate, shortness of breath) for at least one-half hour (30 minutes)? Please check (�) only one. � 3 or more times a week (3) � 1-2 times per month (1) � 1-2 times per week (2) � Do not exercise regularly (0) � Cannot exercise due to disability/ handicap (9) 9. How much of a problem has UNUSUAL fatigue or tiredness been for you OVER THE PAST WEEK? FATIGUE IS � � � � � � � � � � � � � � � � � � � � � FATIGUE IS A NO PROBLEM 0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 9.5 10 MAJOR PROBLEM 10. Over the last 6 months have you had: [Please check (√)] �No �Yes An operation �No �Yes �No �Yes Inpatient hospitalization �No �Yes �No �Yes A new illness, accident or trauma �No �Yes �No �Yes An important new symptom �No �Yes �No �Yes Side effect(s) of any drug �No �Yes �No �Yes Smoke cigarettes regularly �No �Yes Change(s) of arthritis drugs or other drugs Change(s) of address Change(s) of marital status Change job or work duties, quit work, retired Change of medical insurance, Medicare, etc. Change of primary care or other doctor Please explain any "Yes" answer below, or indicate any other health matter that affects you: ____________________________________________________________ ____________________________________________________________ SEX: � Female, � Male ETHNIC GROUP: � Asian, � Black, � Hispanic, � White, � Other______________ Your Occupation __________________________ Circle the number of years of school you have completed: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Work Status: � Full-time � Part-time � Disabled � Homemaker � Self-Employed �Retired � Seeking work � Other_____________________ Record your weight: _____ lbs. height: _____ inches Your Name_____________________________________ Date of Birth ___________ Today’s Date ___________ Thank you for completing this questionnaire to help keep track of your medical care Symptom Checklist From MDHAQ Please check (√) if you have experienced any of the following over the last month: __Fever Weight gain (>10 lb) Weight loss (<10 lb) Feeling sickly Headaches Unusual fatigue Swollen glands Loss of appetite Skin rash or hives Unusual bruising or bleeding Other skin problems Loss of hair Dry eyes Other eye problems Problems with hearing Ringing in the ears Stuffy nose Sores in the mouth Dry mouth Problems with smell or taste __Lump in your throat Cough Shortness of breath Wheezing Pain in the chest Heart pounding (palpitations) Trouble swallowing Heartburn or stomach gas Stomach pain or cramps Nausea Vomiting Constipation Diarrhea Dark or bloody stools Problems with urination Gynecologic (female) problems Dizziness Loss of balance Muscle pain, aches, or cramps Muscle weakness __Paralysis of arms or legs Numbness or tingling in arms/legs Fainting spells Swelling of hands Swelling of ankles Swelling in other joints Joint pain Back pain Neck pain Use of drugs not sold in stores Smoked cigarettes More than 2 alcoholic drinks/day Depression - feeling blue Anxiety - feeling nervous Problems with thinking Problems with memory Problems with sleeping Sexual problems Burning in sex organs Problems with social activities Recent Medical History – Self-report Over the last 6 months have you had [please check (√)]: No No No No No No No No No No No No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes An operation Inpatient hospitalization A new illness, accident or trauma An important new symptom Side effect(s) of any drug Cigarettes regularly Change(s) of arthritis drugs or other drugs Change of address Change of marital status Change of job or work duties, quit work, retired Change of medical insurance, Medicare, etc. Change of primary care or other doctor Please explain any “yes" answer below, or indicate any other health matter that affects you: ___________________________________________________________ HAQ, Pt Global, ROS, Meds, MD Global