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Patient Questionnaires Tutorial: Review of MDHAQ and score RAPID3

Patient Questionnaires Tutorial: Review of MDHAQ and score RAPID3. Theodore Pincus MD Clinical Professor of Medicine New York University tedpincus@gmail.com. Complexities in quantitative assessment of patients with RA and rheumatic diseases.

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Patient Questionnaires Tutorial: Review of MDHAQ and score RAPID3

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  1. Patient Questionnaires Tutorial:Review of MDHAQand score RAPID3 Theodore Pincus MD Clinical Professor of Medicine New York University tedpincus@gmail.com

  2. Complexities in quantitative assessment of patients with RA and rheumatic diseases Laboratory tests are limited in diagnosis and treatment decisions Treat radiograph before damage No single ‘Gold Standard’ measure, eg, blood pressure, cholesterol, glucose, for diagnosis and management in all individual patients Therefore, need indices of 3–7 measures

  3. Complexities in quantitative assessment of patients with RA and rheumatic diseases Patient history and physical examination is more important in clinical management decisions than in diseases with gold standard measure, eg, blood pressure, cholesterol, glucose Patient history information may be captured as quantitative "scientific" data using structured patient self-report questionnaires

  4. MDHAQ: • Page 1 of 2 • a - j: Physical • function • k, l, m: • Psychological distress • 2. Pain • 3. RADAI • Self-report • joint count • 4. Patient global • estimate • RAPID3

  5. 2.7              9.5  9.0 21.2                    Visit 1 – Baseline

  6. Visit 1 N=new drug, C=change in dose, T=taper, D/C=discontinue

  7. 0             0.5   0.5 1.0                    Visit 2 – 2 months after baseline

  8. Visit 2 N = new drug, C = change in dose, T = taper, D/C = discontinue

  9. Visit 5 – 13 months after baseline 0             6.0   5.5 11.5                   

  10. Visit 5 N=new drug, C=change in dose, T=taper, D/C=discontinue

  11. Visit 6 – 15 months after baseline 0             0   0.5 0.5                   

  12. Visit 6 N=new drug, C=change in dose, T=taper, D/C=discontinue

  13. Cross-Sectional Data in Patients With RA: Cohort #2 in 1985 and Cohort #4 in 2000: MDHAQ Scores 1985 2000 2.0 1.5 1.0 0.5 0.0 2.0 1.5 1.0 0.5 0.0 MHAQ MHAQ 0 5 10 15 20 0 5 10 15 20 Disease Duration (Years) Disease Duration (Years) Pincus, Sokka, Kautiainen, Arth Rheum 52:1009, 2005

  14. Cross-Sectional Data in Patients With RA: Cohort #2 in 1985 and Cohort #4 in 2000: Swollen Joint Count Scores 1985 2000 20 16 12 8 4 0 20 16 12 8 4 0 Swollen Joint Count 28 Swollen Joint Count 28 0 5 10 15 20 0 5 10 15 20 Disease Duration (Years) Disease Duration (Years) Pincus, Sokka, Kautiainen, Arth Rheum 52:1009, 2005

  15. Cross-Sectional Data in RA Patients:Cohort #2- 1985 and Cohort #4-2000: Larsen X-Ray score,% of maximum RF- RF+ RF+ RF- 1985 2000

  16. Patients seen for standard rheumatoid arthritis care have significantly better articular, radiographic, laboratory, and functional status in 2000 than in 1985 Pincus, Sokka, Kautiainen, Arth Rheum 52:1009, 2005

  17. Mtx in RA Care: 1980-2005 Jyvaskyla, Finland & Nashville, TN Sokka, Pincus,. Rheumatology (Oxford) 47:1543-1547, 2008.

  18. Indices to assess patients with RA

  19. Spearman correlation rho = 0.657 RAPID3 versus DAS28 in 285 RA patients Pincus, Swearingen, Bergman, Yazici. RAPID3 J Rheumatol. 35:2136-2147, 2008 RAPID=Routine Assessment Patient Index Data; DAS=Disease Activity Score.

  20. RAPID3 versus CDAI in 285 RA patients Pincus, Swearingen, Bergman, Yazici. RAPID3 J Rheumatol. 35:2136-2147, 2008 Spearman correlation rho = 0.738 RAPID=Routine Assessment Patient Index Data; CDAI=Clinical Disease Activity Index.

  21. Time to Score RA Measures - Seconds Pincus et al 2009; Arthritis Care Res. in press

  22. Median Levels of all patients at initiation of Mtx 1996-2001 and mean of 2.6-years later in: 1. 30 incomplete responders initiating biologic agent 2. 63 “control” adequate responders continuing MTX

  23. % of RA patients with abnormal measures at presentation: Evidence – not eminence – based • ESR >28 mm/Hr - 57% • CRP >10 - 58% • Rheumatoid factor positive - 69% • Anti-CCP positive - 67% • Function score >2/10 - 70% • Pain score >2/10 - 89%

  24. Changes in scores (0-10) for DAS28 and RAPID3 from baseline () to endpoint ( ) in two abatacept clinical trials AIM DAS28 RAPID3 ATTAIN Pincus T, et al. Rheumatology (Oxford) 47:345-349, 2008

  25. DAS28, CDAI and RAPID3 show similar scores, categories of high, moderate, low severity and remission, and improvement criteria responses in clinical trials of: • Leflunomide • Methotrexate • Adalimumab • Abatacept • Infliximab • Certolizumab

  26. DAS28, CDAI and RAPID3 Categories

  27. RAPID3 compared to DAS28 categories in 285 RA Patients at 3 Sites Pincus, Swearingen, Yazici, Bergman, J Rheumatol, 35:2136-2147, 2008

  28. Changes in RAPID3 Scores Over 5 Years in RA Patients in Usual Care 1996-2001 RAPID3 categories: 53% 30% 13% 3% 37% 33% 17% 13% 29% 25% 27% 18% 36% 25% 18% 21% 30% 30% 12% 28% High severity(>12) Moderate severity(6.01-12) Low severity(3.01-6) Near remission(3) Patients in Each RAPID3 Category (%) Baseline 6 mo 12 mo 24 mo 60 mo (N=60) (N=60) (N=55) (N=56) (N=43)

  29. Multi-Dimensional Health Assessment Questionnaire (MDHAQ) Page 1

  30. HAQ Page 1 1. Dressing 2. Arising 3. Eating 4. WalkingAids and devicesHelp from an- other person

  31. HAQ & multidimensional HAQ (MDHAQ) HAQ MDHAQ 1st report 1980 1999 Patient completion 5-10 min 5-10 min # ADL 20 10 Psych, sleep No Sleep, anxiety depression Pain VAS 10 cm line 21 circles Pt Global VAS 10 cm line 21 circles Scoring templates No Yes Index No RAPID3 RADAI self-report joint count No Yes MD Global No Optional

  32. HAQ Page 2 5. Hygiene 6. Reach 7. Grip 8. ActivitiesAids and devicesHelp from an- other person

  33. MDHAQ: Page 2 5. Review of systems 6. Morning stiffness 7. Change in status 8. Exercise 9. Fatigue 10. Recent medical history Demographic data MD review

  34. HAQ & multidimensional HAQ (MDHAQ) HAQ MDHAQ Review of Systems No 60 Symptoms Morning stiffness No Yes Change in status No Yes Exercise No Yes Fatigue No VAS Medical history No Surgery, side effects, falls Demographic data No Yes Social history No Yes MD “eyeball” 15 secs 5 secs Time to score 42 secs 10 secs

  35. 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 POORLYVERY ______________________________________________ VERYWELL POORLY

  36. Symptom Checklist From MDHAQ Please check (√) if you have experienced any of the following over the last month: __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 __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

  37. Recent Medical History: Self-report Over the last 6 months have you had [please check (√)]: No Yes An operation No Yes Inpatient hospitalization No Yes A new illness, accident or trauma No Yes An important new symptom No Yes Side effect(s) of any drug No Yes Cigarettes regularly No Yes Change(s) of arthritis drugs or other drugs No Yes Change of address No Yes Change of marital status No Yes Change of job or work duties, quit work, retired No Yes Change of medical insurance, Medicare, etc. No Yes Change of primary care or other doctor Please explain any “yes" answer below, or indicate any other health matter that affects you: ___________________________________________________________

  38. 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 & Hawley J Rheumatol 1998; Fex et al J Rheumatol 1998; Sokka et al J Rheumatol 1999; Barrett et al Rheumatology 2000) Costs(Lubeck et al Arthritis Rheum 1986) Joint replacement surgery(Wolfe & Zwillich Arthritis Rheum 1998) Death(Pincus et al Arthritis Rheum 1984, Ann Intern Med 1994; Wolfe et al J Rheumatol 1988, Arthritis Rheum 1994; Leigh & Fries J Rheumatol 1991; Callahan et al Arthritis Care Res 1996, 1997; Soderlin et al J Rheumatol 1998; Maiden et al Ann Rheum Dis 1999; Sokka et al Ann Rheum Dis 2004)

  39. Time (years) Time (years) Time (years) HAQ ▬▬ < 1 ▬▬ ≥ 1 Pain ▬▬ ≤ 40 ▬▬ > 40 Exercise ▬▬ ≥ 1 ▬▬ < 1 ▬▬ none Mortality in Elderly Normal Finnish population (n=1523)over 5 years by non-biomedical vital signs: a) Functional capacity (HAQ ≥1 vs. <1) b) Pain (>40 vs. ≤40) c) Frequency of physical exercise Cumulative Survival

  40. KeepItSimpleStupid Pincus and Sokka, J Rheumatol, 2009

  41. Complexities in assessment of patients with RA and rheumatic diseases A person with hypertension, hyperlipidemia, osteoporosis, diabetes, goes to the doctor to have a test to find out how she/he is doing. A quantitative measure, e.g., blood pressure, lipid level, bone density, HgA1c supports clinical decisions. No lab test is definitive in all patients with rheumatoid arthritis, and the patient tells the doctor about how she/he is doing. Should a doctor make a clinical decision on medications without recording a quantitative score for the patient’s function and pain?

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