Measures in RA Joint counts, radiographsand laboratory tests

Measures in RA: Joint counts, radiographs, laboratory tests, patient questionnaires advantages and disadvantages t.pincus@vanderbilt.edu It’s all about measurement  “When you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it [and] express it in numbers, your knowledge is of a meager and unsatisfactory kind.” Lord Kelvin – quoted by: Buchanan W, Smythe H. J Rheumatol. 1982:9;653–4. Complexities in assessment of patients with rheumatic diseases: 1. 2. 3. No single “gold standard” (eg, blood pressure, cholesterol) for clinical trials or standard care: therefore, indices of 37 measures. Laboratory tests limited in both diagnosis and treatment - primary criteria are clinical. Patient questionnaires to assess physical function, pain, global status, often best quantitative measures. American College of Rheumatology (ACR) Core Data Set & Disease Activity Score (DAS) 3 Physician/Assessor measures 1. Tender joint count (also in DAS) 2. Swollen joint count (also in DAS) 3. Assessor Global status 3 Patient self-report measures 4. Physical Function - HAQ, HAQ II, MDHAQ 5. Pain 6. Patient Global status (also in DAS) 1 Laboratory Measure 7. Acute phase reactant –ESR, CRP–also in DAS (8. Radiograph – longer than 1 year) Felson et al, Arth Rheum 36:729, 1993. van Riel, Br J Rheumatol 31:793, 1994. RA Measures for clinical research vs clinical care Clinical research Joint count 68/70 joints -tender, swollen, limited motion, pain on motion, deformed X-ray Detailed Larsen, Sharpe/ van der Heijde scores Lab ESR, CRP, anti-CCP, RF Patient questionnaires Complete, long Takes time Complex scoring Results to data center Results unknown in care Clinical care 28 joints – tender, swollen ?Erosions ?Joint space narrowing ESR, CRP, anti-CCP, RF Patient friendly,<10 min Saves time for MD “Eyeball” results Results on clinical flowsheet Adds to clinical care Formal Joint Counts in Management of Patients With RA  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 Joints included in various standard joint counts Joint Temporomandibular Sternoclavicular Acromioclavicular Shoulder Elbow Wrist MCP 66/68 Joints + + + + + + + Ritchie Index + + + + + + + 44 Joints + + + + + + 36 Joints 28 Joints 42 Joints + + + + (-1) + + + + + + + Hand PIP DIP Hip Knee Ankle + + + + + + + + + + + + + + + + + + + + + + + + Talocalcaneal Tarsus MTP Foot DIP + + + + + + A simplified twenty-eightjoint quantitative articular index in rheumatoid arthritis HA Fuchs, RH Brooks, LF Callahan, T Pincus Arthritis Rheum 32:531-537, 1989 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 1–24% of visits 25–49% of visits 50–74% of visits 75–99% of visits Always 11% 14% 16% 14% 13% 32% Median number of seconds to score various RA measures 120 100 80 Seconds 60 40 20 0 28 JT CT Rheum #1 Rheum #2 Rheum #3 Mean 84 113 71 90 DAS28 12.9 16.8 14.6 14.6 HAQ MDHAQ RAPID FN + + PN, RAPID2 RAPID 3 4MD PN, GL GL 41.5 42.2 41.9 6.4 8.5 7.5 7.5 4.3 4.4 4 4.3 9.2 12.1 9.1 9.6 11.8 16.1 12 12.2 RAPID RAPID 5 4JC 19 22.8 15.3 19 19.4 27.3 17.5 19.4 Relative efficiencies of 7 ACR Core Data Set measures in 4 adalimumab clinical trials a. Arithmetic change 3.00 2.72 2.65 2.14 2.12 1.86 1.48 1.10 1.00 0.92 0.94 1.00 1.00 1.55 1.60 1.42 1.30 1.52 1.48 1.36 1.66 1.43 1.27 1.17 2.50 2.00 1.50 1.00 0.50 2.06 1.12 1.00 0.60 0.22 Tender Joint Count Swollen Joint Coun Assessor Global CRP Function (HAQ) Pain Patient Global 0.00 ARMADA DE011 DE019 STAR Some Problems With Joint Counts in RA 1. Joint counts have lower relative efficiencies than MD global and patient measures 2. Formal studies indicate poor reproducibility 3. Tedious to perform – interrupt visit 4. Most visits to a rheumatologist include a careful joint examination, but do not include a formal joint count 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 Mild Moderate Severe a.LEFT FINGERS  b.LEFT WRIST  c.LEFT ELBOW  d.LEFT SHOULDER  e.LEFT HIP  f.LEFT KNEE  g.LEFT ANKLE  h.LEFT TOES  q.NECK 0 0 0 0 0 0 0 0 0          1 1 1 1 1 1 1 1 1          2 2 2 2 2 2 2 2 2          3 3 3 3 3 3 3 3 3 i.RIGHT FINGERS j.RIGHT WRIST k.RIGHT ELBOW l.RIGHT SHOULDER m.RIGHT HIP n.RIGHT KNEE o.RIGHT ANKLE p.RIGHT TOES r.BACK          0 0 0 0 0 0 0 0 0          1 1 1 1 1 1 1 1 1          2 2 2 2 2 2 2 2 2          3 3 3 3 3 3 3 3 3 Should contemporary rheumatoid arthritis clinical trials be more like standard patient care and vice versa? T Pincus, T Sokka Ann Rheum Dis 63(Suppl II):ii32-ii39, 2004 Radiographs in Diagnosis and Management of Patients With RA  Excellent quantitative scoring systems - Sharp, van der Heijde, Larsen, Genant  Erosions are closest to pathognomonic sign in RA  Reflect cumulative damage of disease Radiographic and joint count findings of the hand in rheumatoid arthritis: related and unrelated findings HA Fuchs, LF Callahan, JJ Kaye, RH Brooks, EP Nance, T Pincus Arthritis Rheum 31:44-51, 1988 Radiographs and joint counts in RA: Related and unrelated findings Fuchs, Callahan, Kaye, Brooks, Nance, Pincus Arthritis Rheum 31:44, 1988 Associations of HLA-DR4 with rheumatoid factor and radiographic severity in rheumatoid arthritis. NJ Olsen, LF Callahan, RH Brooks, EP Nance, JJ Kaye, P Stastny, T Pincus Am J Med 84:257-264, 1988 Strongly and Weakly Related Measures to Assess RA Radiographs ESR, CRP Shared epitope Rheumatoid factor Joint deformity Duration of disease Functional disability Pain Patient global Joint swelling Joint tenderness Age Predicting Mortality in RA: Most Baseline Measures Are Worse in Patients Who Will Die Over a 5-Year Period Mean Baseline Values Age (years) ARA functional class Number of comorbidities Walking time ESR mHAQ score Learned helplessness Global self-report Number of extra-articular features Duration of disease Years of education Joint count Radiograph score RF titer Pain Callahan LF, et al. Arthritis Care Res. 1997;10:381–394. Alive 55.1 2.2 1.1 10.8 33.8 1.98 2.41 2.6 0.2 9.1 10.8 12.8 1.2 2.7 5.40 Dead 65.5 2.6 2.1 16.8 48.3 2.32 2.55 3.0 0.5 12.7 9.4 15.9 1.4 2.9 5.19 P Value < 0.001 < 0.001 < 0.001 < 0.001 0.004 0.005 0.007 0.01 0.02 0.03 0.03 0.04 0.20 0.28 0.68 RA Cohort #2- Cox Proportional Hazards Model Analyses Including Demographic, Functional, SelfReport, Joint Count, X-ray, Laboratory and Disease Variables in 206 patients Univariate RR P (95% CL) Value 1.07 <0.001 1.63 2.00 1.04 0.89 1.01 1.02 1.03 1.40 <0.001 0.003 0.02 0.007 0.005 0.10 0.04 0.17 Stepwise Model RR P (95% CL) Value 1.06 <0.001 1.40 1.76 ------0.02 0.02 ------- Age Comorbidity MHAQ ADL Score Disease duration Education ESR Joint count Walking time X-ray Arthritis Care Res 10:381,1997 5-Year Survival in 206 Patients with RA: 1985-1990 Rheumatoid Factor 100 100 MHAQ Score Survival (%) 60 40 20 0 0 12 24 36 48 60 Survival (%) 80 80 60 40 20 0 0 12 24 36 48 60 Absent (29) Present (175) 1.00 (12) 1.01–1.99 2.00–2.99 (91) 3.00 (21) (86) Months After Baseline Months After Baseline Arthritis Care Res. 1997;10:381. Predictors of mortality in RA n=1922 Odds Ratio HAQ 2.93 Pt Global severity 1.28 Pain 1.25 Depression 1.34 Anxiety 1.28 Grip strength 1.01 ESR 1.01 RF, titer 1.13 Hematocrit 1.06 Larsen X-ray score 1.04 Duration 1.01 Joint count 1.01 Age Comorbidities Male 1.09 1.19 2.10 z score p value 11.1 <0.001 8.5 <0.001 8.3 <0.001 8.8 <0.001 7.2 <0.001 6.2 <0.001 5.7 <0.001 4.6 <0.001 3.8 <0.001 4.7 0.002 2.1 0.036 0.76 0.445 11.9 4.69 5.28 <0.001 <0.001 <0.001 Wolfe et al Arth Rheum 48:1530, 2003 The HAQ or MDHAQ, not a joint count, lab test or X-ray, is Best Predictor in RA of…      Functional status (Pincus et al. Arthritis Rheum. 1984, Wolfe et al. J Rheumatol. 1991) Work disability (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 ) Costs (Lubeck et al. Arthritis Rheum. 1986) Joint replacement surgery (Wolfe and Zwillich. Arthritis Rheum. 1998) Death (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) Some Problems With Radiographs in RA 1. Quantitative score tedious to perform 2. Treatment initiated prior to erosions – MRI, ultrasound are more sensitive 3. Radiographic damage has poor prognostic value for work disability, death and even joint replacement Laboratory Tests in Diagnosis and Management of Patients With RA 1. Most important measure in most clinical situations, e.g., cholesterol, hemoglobin, creatinine, glucose, etc. 2. Many tests may be of value – CBC, ESR, CRP, RF, anti-CCP 3. No work for the rheumatologist ESR Values in Patients With RA ESR ≥ 28 mm/h Females Males 63% 55% ESR < 28 mm/h 37% 45% Wolfe F, Michaud K, J Rheumatol. 1994;21:1227–1237. ESR and CRP at 1st Visit a. Jyvaskyla, FIN CRP ESR ≥28 mm/hr <28 mm/hr >10 mg/L <10 mg/L Total 775 (44%) 199 (11%) 974 (55%) 202 (12%) 568 (33%) 770 (45%) Total 977 (56%) 767 (44%) 1744 (100%) Total b. Nashville, TN, USA CRP ESR ≥28 mm/hr <28 mm/hr >10 mg/L <10 mg/L Total 48 (28%) 29 (17%) 77 (45%) 22 (13%) 71 (42%) 93 (55%) 70 (41%) 100 (59%) 170 (100%) The level of inflammation in rheumatoid arthritis is determined early and remains stable over the longterm course of the illness F Wolfe, T Pincus J Rheumatol 28:1817-1824, 2001 Some Problems With Laboratory Tests in Diagnosis and Management of RA 1. ESR & CRP - normal in 40% at presentation 2. Anti-CCP & RF - negative in 20–50% of patients 3. Treatment decisions are based primarily on clinical criteria 4. Lab tests have good prognostic value for radiographic damage but poor prognostic value for work disability or death CRP = C-reactive protein; CCP = cyclic citrullinated protein Why should rheumatologists collect patient self-report data in routine clinical care? 1. Significant correlation with joint counts, ESR, X-ray 2. More reproducible than joint counts, lab, X-ray score 3. As informative as ACR20/50/70 or DAS in clinical trials 4. Predict work disability, costs, TJR, and premature death more significantly than traditional measures 5. Data most relevant to patient and family 6. Saves time for patient and MD to focus on major patient matters including under-appreciated concerns 7. Record quantitative data to document status from one visit to the next, particularly over long periods 8. Doctor does not measure but interprets measures 9. MDHAQ- all key data and indices one side of one page 10.Adds to the rheumatologist to be a better doctor ACR Core Data Set Measure changes - 12 Months: Leflunomide (LEF) vs Methotrexate (MTX) vs Placebo (PBO) Measure: Tender Jts Swollen Jts MD Global ESR FN- HAQ FN-MHAQ Pain Pt Global LEF -7.7 -5.7 -2.8 -6.3 -0.45 -0.29 -2.2 -2.1 PBO MTX -3.0 -2.9 -1.0 +2.6 +0.03 +0.07 -0.4 +0.1 -6.6 -5.4 -2.4 -6.5 -0.26 -0.15 -1.7 -1.5 Effect Relative Size Efficiency -0.59 1.00 -0.44 0.56 -0.68 1.33 -0.41 0.48 -0.80 1.84 -0.69 1.37 -0.65 1.21 -0.81 1.88 Strand V, et al. Arch Intl Med. 1999; 159:2542-2550; Tugwell P, et al. Arthritis Rheum. 2000; 43:506-514. 9- to 10-Year Survival According to Quantitative Markers in Three Chronic Diseases A Survival (%) Rheumatoid Arthritis – Activities of Daily Living 100 B Survival (%) Rheumatoid Arthritis – Formal Education Level 100 >12 Years 9–12 Years 80 60 40 20 (Data from Pincus et al, 1987) >90% 81%–90% 80 60 40 20 (Data from Pincus et al, 1987) % Active “With Ease” 8 Years 71%–80% 70% Months 0 20 40 60 80 100 0 20 40 60 80 100 Months C Survival (%) Hodgkin’s Disease – Anatomic Stage 100 80 60 40 20 (Data from Kaplan, 1972) D Survival (%) Coronary Artery Disease – # of Involved Vessels 100 80 60 40 20 (Data from Proudfit et al, 1978) Stage I Stage II All Stages, All Causes 1 Artery 2 Arteries 3 Arteries LCA Stage III Stage IV Years 8 10 Years 10 0 2 4 6 0 2 4 6 8 Relative Risk of Death Over 12-15 Years in rheumatoid arthritis (RA) and cardiovascular (CV) disease according to baseline severity indicators RA – 75 pts – 15 yrs - Pincus et al, Ann Int Med 120:26,1994 Functional status on patient questionnaire # of Involved Joints < vs > 91.5% “with ease” > vs < 18 joints 2.9:1 3.0:1 CV disease – 312,000 pts – 12 yrs – Neaton et al, Arch Int Med 152:56,1992 Serum cholesterol Systolic blood pressure Diastolic blood pressure Smoking >245 vs <182 mg/Dl >142 vs <118 mmHg >92 vs <76 mmHg >26 vs 0 cigarettes/day 2.9:1 3.0:1 2.9:1 2.9:1 Data adjusted for age, sex, education, disease duration Treatment with TNF blockers is associated with reduced premature mortality in patients with rheumatoid arthritis LTH Jacobsson, C Turesson, JA Nilsson, IF Petersson, E Lindqvist, T Saxne, P Geborek Arthritis Rheumatism 54:S330, 2006 A Practical System That (Almost) Works For Routine Assessment of Functional Status, Fatigue and Psychological Distress 1. Patient given 2-page questionnaire by receptionist: completed in waiting room 2. Nurse (or physician) reviews and/or completes medication data 3. Physician does as little as possible: completes brief data (may include joint count) 4. Office staff enters flow sheet with laboratory data Patient questionnaires in clinical research vs clinical care Clinical research Complete, long Takes time Complex scoring No scoring at visit Results unknown in care Send to data center Enter into computer Clinical care Patient friendly,<10 min Saves time for MD “Eyeball” results Scoring templates for MD Adds to clinical care Review with patient Enter unto flowsheet add to care, documentation HAQ & multidimensional HAQ (MDHAQ) HAQ MDHAQ 1st report 1980 1999 Patient completion 5-10 min 5-10 min # ADL 20 10 Pain VAS 10 cm line 21 circles Pt Global VAS 10 cm line 21 circles Psych, sleep No Sleep, anxiety RADAI self-report depression joint count No Yes Fatigue No VAS Review of Systems No 60 Symptoms Medical history No Surgery, side effects Demographic data No Yes Social history No Yes Scoring templates No Yes Index No RAPID MD scan (“eyeball”) 30 secs 5 secs Time to score 41.8 secs7.5 secs This questionnaire includes information not available from blood tests, X-rays, or any source other than you. Please try to answer each question, even if you do not think it is related to you at this time. Try to complete as much as you can yourself, but if you need help, please ask. There are no right or FOR OFFICE wrong answers. Please answer exactly as you think or feel. Thank you. USE ONLY Multi-Dimensional Health Assessment Questionnaire (R771-NP2) MDHAQ Page 1 1. Please check (√) the ONE best answer for your abilities at this time: Without With With OVER THE LAST WEEK, were you able to: ANY SOME MUCH Difficulty Difficulty Difficulty a. Dress yourself, including tying shoelaces and doing buttons? _____0 _____1 _____2 b. Get in and out of bed? _____0 _____1 _____2 c. Lift a full cup or glass to your mouth? _____0 _____1 _____2 d. Walk outdoors on flat ground? _____0 _____1 _____2 e. Wash and dry your entire body? _____0 _____1 _____2 f. Bend down to pick up clothing from the floor? _____0 _____1 _____2 g. Turn regular faucets on and off? _____0 _____1 _____2 h. Get in and out of a car, bus, train, or airplane? _____0 _____1 _____2 i. Walk two miles or three kilometers, if you wish? _____0 _____1 _____2 j. Participate in recreational activities and sports _____0 _____1 _____2 as you would like, if you wish? k. Get a good night’s sleep? _____0 _____1.1 _____2.2 l. Deal with feelings of anxiety or being nervous? _____0 _____1.1 _____2.2 m.Deal with feelings of depression or feeling blue? _____0 _____1.1 _____2.2 UNABLE To Do _____3 _____3 _____3 _____3 _____3 _____3 _____3 _____3 _____3 _____3 _____3.3 _____3.3 _____3.3 1.a-j FN (0-10) 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 2.PN (0-10) 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 4.PTGL (0-10) 2. 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 AS BAD AS PAIN 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 IT COULD BE 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 Mild Moderate Severe a.LEFT FINGERS  b.LEFT WRIST  c.LEFT ELBOW  d.LEFT SHOULDER  e.LEFT HIP  f.LEFT KNEE  g.LEFT ANKLE  h.LEFT TOES  q.NECK RAPID 3 (0-30) 3.a-pPTJT(0-10) 0 0 0 0 0 0 0 0 0          1 1 1 1 1 1 1 1 1          2 2 2 2 2 2 2 2 2          3 3 3 3 3 3 3 3 3 i.RIGHT FINGERS j.RIGHT WRIST k.RIGHT ELBOW l.RIGHT SHOULDER m.RIGHT HIP n.RIGHT KNEE o.RIGHT ANKLE p.RIGHT TOES r.BACK          0 0 0 0 0 0 0 0 0          1 1 1 1 1 1 1 1 1          2 2 2 2 2 2 2 2 2          3 3 3 3 3 3 3 3 3 4. 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 1.0 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 For Office Use Only: RAPID 3 VERY POORLY RAPID 4 (0-10) 1=0.2 25=5.2 2=0.4 26=5.4 3=0.6 27=5.6 4=0.8 28=5.8 5=1.0 29=6.0 6=1.3 30=6.3 7=1.5 31=6.4 8=1.7 32=6.7 9=1.9 33=6.9 10=2.1 34=7.1 11=2.3 35=7.3 12=2.5 36=7.5 13=2.7 37=7.7 14=2.9 38=7.9 15=3.1 39=8.1 16=3.3 40=8.3 17=3.5 41=8.5 18=3.8 42=8.8 19=4.0 43=9.0 20=4.2 44=9.2 21=4.4 45=9.4 22=4.6 46=9.6 23=4.8 47=9.8 24=5.0 48=10 RAPID 4 (0-40) Please turn to the other side RAPID 3 (0-10) RAPID 4 NR: 1=0.3, 2=0.7, 3=1.0 LS: 4=1.3, 5=1.7, 6=2.0 NR: 1=0.3, 2=0.5, 3=0.8, 4=1.0 LS: 5=1.3, 6=1.5, 7=1.8, 8=2.0 MS: 7=2.3, 8=2.7, 9=3.0, 10=3.3, 11=3.7, 12=4.0 MS: 9=2.3, 10=2.5, 11=2.8, 12=3.0, 13=3.3, 14=3.5, 15=3.8, 16=4.0 HS: 13=4.3, 14=4.7, 15=5.0, 16=5.3, 17=5.7,18=6.0, HS: 17=4.3, 18=4.5, 19=4.8, 20=5.0, 21=5.3, 22=5.5, 23=5.8, 24=6.0, 19=6.3, 20=6.7, 21=7.0, 22=7.3, 23=7.7, 24=8.0, 25=6.3, 26=6.5, 27=6.8, 28=7.0, 29=7.3, 30=7.5, 31=7.8, 32=8.0, 25=8.3, 26=8.7, 27=9.0, 28=9.3, 29=9.7, 30=10.0 33=8.3, 34=8.5, 35=8.7, 36=9.0, 37=9.3, 38=9.5, 39=9.8, 40=10.0 NR: 1=0.2, 2=0.4, 3=0.6, 4=0.8 5=1.0 LS: 6=1.2, 7=1.4, 8=1.6, 9=1.8, 10=2.0, RAPID 5 MS:11=2.2, 12=2.4, 13=2.6, 14=2.8, 15=3.0, 16=3.2, 17=3.4, 18=3.6, 19=3.8, 20=4.0 (0-10) HS: 21=4.2, 22=4.4, 23=4.6, 24=4.8, 25=5.0, 26=5.2, 27=5.4, 28=5.6, 29=5.8, 30=6.0, 31=6.2, 32=6.4, 33=6.6, 34=6.8, 35=7.0, 36=7.2, 37=7.4, 38=7.6, 39=7.8, 40=8.0, 41=8.2, 42=8.4, 43=8.6, 44=8.8, 45=9.0, 46=9.2, 47=9.4, 48=9.6, 49=9.8, 50=10.0 \ \\ MDGLOBAL(0-10)) RAPID 5 (0-50) Copyright: Health Report Services, Telephone 615-936-2151, E-mail t.pincus@vanderbilt.edu ? ? ? ? 43 Keep It Simple Stupid Considering all the ways in which illness and health conditions may affect you at this time, please indicate below how you are doing: VERY                      VERY WELL 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 POORLY VERY WELL ______________________________________________ VERY POORLY RADAI vs Core Data Set measures (n=274) RADAI Swollen 28 JC Tender 28 JC MDGlobal VAS ESR CRP FN MDHAQ Pt Global VAS Pain VAS RADAI --0.42 0.55 0.52 0.13* 0.08*** 0.68 0.69 0.71 SJC 28 0.42 --0.55 0.74 0.23 0.18** 0.47 0.36 0.39 TJC 28 0.55 0.55 --0.57 0.32 0.21 0.52 0.53 0.56 ESR 0.13* 0.23 0.32 0.26 --0.50 0.25 0.21 0.21 Adjusted for age, disease duration, education and center, All p<0.0001, except *p=0.035, **p=0.003, ***p>0.05 RA 35 yo F (#13) Onset: 02/2003 Visit 1 Visit Date Function (0-10) Pain (0-10) 3/5/03 6.33 7.8 9.1 N-10qd N15qw N-1qd 200prn Global (0-10) ESR Prednisone Methotrexate Folic Acid Ibuprofen Hydrocodone 1q6h N = new drug, C = change in dose, T = taper, D/C = discontinue RA 35 yo F (#13) Onset: 02/2003 Visit 2 Visit Date Function (0-10) Pain (0-10) 3/5/03 3/11/03 6.33 2.00 7.8 9.1 N-10qd N15qw 5.6 5.6 17 C-5bid 15qw n25biw Global (0-10) ESR Prednisone Methotrexate Etanercept Folic Acid N-1qd 1qd Ibuprofen Hydrocodone 200prn 1q6h 200prn 1q6h N = new drug, C = change in dose, T = taper, D/C = discontinue RA 35 yo F (#13) Onset: 02/2003 Visit 3 Visit Date Function (0-10) Pain (0-10) 3/5/03 3/11/03 3/25/03 6.33 2.00 2.00 7.8 9.1 N-10qd N15qw 5.6 5.6 17 C-5bid 15qw n25biw 1.8 2.8 11 T-5qd 15qw 25biw 1qd Global (0-10) ESR Prednisone Methotrexate Etanercept Folic Acid N-1qd 1qd Ibuprofen Hydrocodone 200prn 1q6h 200prn 1q6h 200prn 1q6h N = new drug, C = change in dose, T = taper, D/C = discontinue RA 35 yo F (#13) Onset: 02/2003 Visit 4 Visit Date Function (0-10) Pain (0-10) 3/5/03 3/11/03 3/25/03 5/20/03 6.33 2.00 2.00 1.67 7.8 9.1 N-10qd N15qw 5.6 5.6 17 C-5bid 15qw n25biw 1.8 2.8 11 T-5qd 15qw 25biw 1qd 1.7 2.4 30 5qd C20qw 25biw 1qd Global (0-10) ESR Prednisone Methotrexate Etanercept Folic Acid N-1qd 1qd Ibuprofen Hydrocodone 200prn 1q6h 200prn 1q6h 200prn 1q6h 200prn D/C N = new drug, C = change in dose, T = taper, D/C = discontinue RA 35 yo F (#13) Onset: 02/2003 Visit 5 Visit Date Function (0-10) Pain (0-10) 3/5/03 3/11/03 3/25/03 5/20/03 8/19/03 6.33 2.00 2.00 1.67 1.00 7.8 9.1 N-10qd N15qw 5.6 5.6 17 C-5bid 15qw n25biw 1.8 2.8 11 T-5qd 15qw 25biw 1qd 1.7 2.4 30 5qd C20qw 25biw 1qd 1.3 1.6 16 C-4qd 20qw 25biw 1qd Global (0-10) ESR Prednisone Methotrexate Etanercept Folic Acid N-1qd 1qd Ibuprofen Hydrocodone 200prn 1q6h 200prn 1q6h 200prn 1q6h 200prn D/C 200prn N = new drug, C = change in dose, T = taper, D/C = discontinue RA 35 yo F (#13) Onset: 02/2003 Visit 10 Visit Date Function (0-10) Pain (0-10) 3/5/03 3/11/03 3/25/03 5/20/03 8/19/03 1/24/06 6.33 2.00 2.00 1.67 1.00 0.67 7.8 9.1 N-10qd N15qw 5.6 5.6 17 C-5bid 15qw n25biw 1.8 2.8 11 T-5qd 15qw 25biw 1qd 1.7 2.4 30 5qd C20qw 25biw 1qd 1.3 1.6 16 C-4qd 20qw 25biw 1qd 2.8 2.2 6 4qd 20qw 50qw 1qd Global (0-10) ESR Prednisone Methotrexate Etanercept Folic Acid N-1qd 1qd Ibuprofen Hydrocodone 200prn 1q6h 200prn 1q6h 200prn 1q6h 200prn D/C 200prn 200prn N = new drug, C = change in dose, T = taper, D/C = discontinue The MDHAQ in Clinical Rheumatology • In rheumatoid arthritis, the MDHAQ distinguishes MTX or LEF from placebo in a clinical trial as effectively as a joint count or the ACR 20 • In osteoarthritis, the MDHAQ distinguishes NSAID from acetaminophen as effectively as the WOMAC • In fibromyalgia, the MDHAQ distinguishes patients from those with rheumatoid arthritis as effectively as an ESR Pain/MHAQ Ratio in RA and Fibromyalgia 10 9 8 2 Years >2 Years P-VAS/D-ADL Ratio 7 6 5 4 3 2 1 0 Rheumatoid Arthritis Non-Inflammatory Diffuse Muskuloskeletal Pain Callahan and Pincus. Arthritis and Rheumatism. 1990;33:1317. DNA Binding of Serums- SLE and Control Patients 100 90 Other = Diseased controls SS = Sjögren’s Syndrome SLE = Unselected Patients with SLE % DNA Bound 80 70 60 50 40 30 20 10 0 Value of 20% indicates abnormal binding activity Normal (84)Other (57)SS (24) SLE (44) Pincus et al. NEJM. 1969;281:701. Further clues to recognition of patients with fibromyalgia from a simple 2-page patient multidimensional health assessment questionnaire (MDHAQ) DA DeWalt, GW Reed, T Pincus Clin Exp Rheumatol 22:453-461, 2004 Activities of Daily Living (ADL) in prognosis of non- Rheumatic Diseases • In congestive heart failure, ADL predict 36 month mortality as ejection fraction Konstam, Am J Cardiology 78:890, 1996 • In AIDS, ADL predict 36 month mortality as CD4/CD8 ratios, clinical AIDS prognostic staging (CAPS), severity classification for AIDS hospitalzations (SCAH) Justice, J Clin Epidemiology 49:193, 1996 • In hospitalized elder patients, ADL predict one year mortality beyond physiologic data and comorbidities Covinsky, J Gen Intern Med 12:203, 1997 Some 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 Multidimensional Health Assessment Questionnaire AT THIS MOMENT, are you able to: Dress yourself, including tying shoelaces and 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 2 miles or 3 kilometers? Participate in sports and games as you would like? Get a good night’s sleep? Deal with feelings of anxiety or being nervous? Deal with feelings of depression or feeling blue? Without ANY Difficulty ---------------------------------------With SOME Difficulty ---------------------------------------With MUCH Difficult ---------------------------------------UNABLE To Do ---------------------------------------- How much pain have you had because of your condition IN THE PAST WEEK? Place a mark on the line below to indicate how severe your pain has been: NO PAIN Considering all the ways in which your illness and and health conditions may affect you at this time, place a mark to show how you are doing: PAIN AS BAD AS IT COULD BE VERY WELL VERY POORLY 5-Year Survival in 206 Patients With RA: Cohort #2 – 19851990 Rheumatoid Factor 100 100 MHAQ Score Survival (%) 60 40 20 0 0 12 24 36 48 60 Survival (%) 80 80 60 40 20 0 0 12 24 36 48 60 Absent (29) Present (175) 0.00 (12) 0.01–0.99 (91) 1.00–1.99 (86) >2.00 (21) Months After Baseline Arthritis Care Res 10:381,1997 Months After Baseline Evidence-Based Practice or Practice-Based Evidence T Pincus, T Sokka? Nature Clinical Practice Rheumatology 2:114-115, 2006