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A proposed 15 second checklist of 10 measures for all usual care rheumatology visits

A proposed 15 second checklist of 10 measures for all usual care rheumatology visits Theodore Pincus, MD Clinical Professor of Medicine New York University school of Medicine tedpincus@gmail.com. What is the most significant risk factor for mortality over 5-20 years in patients with RA?. 5.

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A proposed 15 second checklist of 10 measures for all usual care rheumatology visits

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  1. A proposed 15 second checklist of 10 measures for all usual carerheumatology visits Theodore Pincus, MD Clinical Professor of Medicine New York University school of Medicine tedpincus@gmail.com

  2. What is the most significant risk factor for mortality over 5-20 years in patients with RA? 5 • Presence of rheumatoid factor • Poor functional status • Quantitative radiographic score • Presence of ACRA (anti-CCP) • Number of swollen joints

  3. What is the number of units in a Sharp/van der Heidje radiographic score? 5 • 64 • 128 • 224 • 448 • 660

  4. Approximately what proportion of new patients with RA have an ESR greater than 28mm/Hr? 5 • 50% • 60% • 70% • 80% • 90%

  5. Approximately what proportion of new patients with rheumatoid arthritis have anti-citrullinated peptide antibodies (ACPA or anti-CCP)? 5 • 50% • 60% • 70% • 80% • 90%

  6. What is the primary reason that “revolutionary” new biological therapies for RA lead to only 60% ACR 20 responses? 5 • Non-targeted different cytokines causing inflammation • Fibromyalgia • Damage to joints • Design of clinical trails

  7. A proposed 15 second checklist of 10 measures for all usual carerheumatology visits Theodore Pincus, MD Clinical Professor of Medicine New York University school of Medicine tedpincus@gmail.com

  8. A checklist is a type of informational job aid used to reduce failure by compensating for potential limits of human memory and attention. It helps to ensure consistency and completeness in carrying out a task. A basic example is the "to do list.”

  9. An airline pilot (and now often a surgeon) must complete a standard checklist before using his/her skills to fly an airplane (or operate).

  10. Surgical Safety Checklist • Has the patient confirmed his/her identity, site, procedure, and consent? • Is the site marked? • Is the anaesthesia machine and medication • check complete? • Is the pulse oximeter on the patient and • functioning? • Does the patient have a known allergy? • Difficult airway or aspiration risk? • Risk of >500ml blood loss (7ml/kg in children)?

  11. How many agree with these statements? • Rheumatologists help their patients as much as any specialist helps any group of patients • Rheumatology care is underappreciated by the general medical community, public, payers • A primary explanation may be that rheumatologists generally little data to document improvement quantitatively

  12. Why shouldn’t a rheumatologist follow a “scientific” procedure similar to pilots and surgeons to use a quantitative checklist at each patient visit before using skills in clinical care?

  13. 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 32% 25%–49% of visits 11% 50%–74% of visits 14% 75%–99% of visits 16% Always 14% Pincus T, et al. Ann Rheum Dis. 2006;65:820-822.

  14. Clinical Decisions Survey All clinical encounters for diagnosis and management of different diseases include 5 sources of clinical information: Clinician-intensive (1) patient history (2) physical examination Clinician-non-intensive (3) vital signs (4) laboratory tests (5) ancillary data, e.g., imaging studies, endoscopies, etc.

  15. Clinical Decisions Survey Please indicate your opinion of the importance of each of 5 sources to provide 0-20%, 21-40%, 41-60%, 61-80%, or 81-100% of information for diagnosis and management of 8 diseases: hypertension diabetes mellitus rheumatoid arthritis hypercholesterolemia pulmonary fibrosis ulcerative colitis lymphoma congestive heart failure

  16. Highest ranked source of clinical information 588 MDs: McCollum, Durusu Tanriover, Akalžn , H Yazici, Pincus: EULAR 2010

  17. Most rheumatologists say that a patient history and doctor’s physical examination are more important than laboratory tests in clinical decisions. • However, the only quantitative data in the usual medical record are laboratory tests. • Therefore, only “gestalt” narrative “unscientific” MD opinions are available to try to recognize whether patients are better or worse over long periods. • Despite clinical advances, most rheumatology patient encounters are conducted very similarly to 40 years ago.

  18. Standard scientific measures in medical care

  19. Standard scientific measures in medical care

  20. Why is a checklist needed for optimal assessment of patients with rheumatic diseases? No single ‘Gold Standard’ measure, e.g., blood pressure, cholesterol, glucose, for diagnosis and management in all individual patients Laboratory tests, the primary source of quantitative data in many diseases, are limited in rheumatic diseases Indices of 3–7 measures, based on Core Data Set used in formal clinical research

  21. RA Core Data Set – 7 or 8 measures Felson et al, Arthritis Rheum 36:729, 1993. van Riel, Br J Rheumatol 31:793, 1994.

  22. What should be included in a rheumatology visit checklist? • Types of measures in care of patients with rheumatic diseases: • Laboratory tests • Joint counts • Radiographic scores • Patient questionnaire scores

  23. Laboratory tests for a rheumatology visit checklist?

  24. "the erythrocyte sedimentation rate is increased in nearly all patients with active RA” Lipsky PE. Rheumatoid arthritis. In: Fauci AS, Langford CA, eds. Harrison's Medicine. New York: McGraw-Hill,2006:85. “at least 5% of patients with clinically active disease may have a normal ESR” Chatham WW, Blackburn WD, Jr. Laboratory findings in rheumatoid arthritis. In: Koopman WJ, Moreland LW, editors. Arthritis and allied conditions: a textbook of rheumatology. Philadelphia, PA: Lippincott, Williams & Wilkins, 2005:1207 Textbook statements concerning ESR in RA

  25. Traditional approaches to clinical expertise: EMINENCE BASED MEDICINE - making the same mistakes with increasing confidence over an impressive number of years ELOQUENCE BASED MEDICINE - a year-roundsuntan and brilliant oratory may overcome absence of any supporting data ELEGANCE BASED MEDICINE - where the sartorialsplendor of a silk-suited sycophant substitutes for substance The modern alternative? EVIDENCE BASED MEDICINE- the best approach to clinical data - requires information from clinical observational data in addition to clinical trials Pincus and Tugwell J Rheumatol 2006

  26. ESR Values in Patients With RA Wolfe F, Michaud K, J Rheumatol. 1994;21:1227–1237. Wichita KS, USA Similar results have been reported from: Nashville, TN, USA Jyvaskyla, Finland Oslo, Norway Nancy, France Groningen, The Netherlands Belfast, Ireland

  27. ESR in 7 Locations 1994-2005 1- Wolfe and Michaud, J Rheumatol. 1994;21:1227–1237. 2- Smedstad, Kvein, et al. Br J Rheumatol 1996;35:746-751. 3- Sokka T, Kauitinen, Pincus. J Rheumatol. 2009;36(1):1387-1390.

  28. Meta-analysis: Anti-cyclic citrullinated peptide (CCP) antibody and rheumatoid factor (RF) Nishimura K et al. Annals of Internal Medicine 146:797-808, 2007

  29. Meta-analysis: Anti-cyclic citrullinated peptide (CCP) antibody and rheumatoid factor (RF) Nishimura K et al. Annals of Internal Medicine 146:797-808, 2007

  30. % 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% Wolfe F, et al. J Rheumatol. 1994;21:1227-37. Sokka T, et al. J Rheumatol. 2009;36:1387-90. Nishimura K, et al. Ann Intern Med. 2007;146:797-808. Pincus T, Swearingen CJ. [Abstract #432] Arthritis Rheum 2009;60(Suppl):S160

  31. Proposed Laboratory Biomarkers for Rheumatoid Arthritis Over 60 Years 1950s Rheumatoid factor 1960s Immune complexes 1970s HLA type, Prostaglandins 1980s Shared epitope 1990s Monoclonal Abs,Anti-CCP 2000s Genes, cytokine targets

  32. Of course, the laboratory remainsthe primary source of further understanding of pathogenesisand advances in therapy. • Nonetheless, for clinical care, laboratory tests have substantial limitations, including normal values in 30-50% of individual patients with many diseases, and often do not change decisions about therapy.

  33. Formal quantitative joint count for a rheumatology visit checklist?

  34. A simplified twenty-eight-joint quantitative articular index in rheumatoid arthritis HA Fuchs, RH Brooks, LF Callahan, T Pincus Arthritis Rheum 32:531-537, 1989

  35. Relative efficiencies of 7 ACR Core Data Set measures in 4 adalimumab clinical trials

  36. Relative efficiencies of 7 Core Data Set measures and 3 Indices, DAS28, CDAI, and RAPID3, to distinguish patients treated with infliximab vs control therapies in ATTRACT and ASPIRE clinical trials Furer, Pincus, et al, EULAR 2009

  37. Changes in measures in 100 RA patients – 1985-1990 over 5 years - effect size Type of measure: Tenderness Swelling Joint count Pain on motion Deformity Better Limited motion Radiographic Joint space narrowing Worse Erosions Malalignment Erythrocyte sedimentation rate Laboratory Rheumatoid factor titer Hemoglobin Morning stiffness Clinical Grip strength Walk time Button time Functional status–MHAQ Patient questionnaire Globalstatus Pain–visual analog scale Helplessness –1.5 –1.3 – 1.1 – 0.9 – 0.7 – 0.5 – 0.3 – 0.1 0.1 0.5 0.3 Effect Size MHAQ=modified Health Assessment Questionnaire. Callahan, Pincus et al. Arthritis Care Res 1997;10:381–94

  38. Some Limitations of Formal Swollen and Tender Joint Counts Relative efficiencies to distinguish active from control treatments in clinical trials are similar or lower than global and patient measures May improve over 5 years while joint deformity and functional disability may progress

  39. Joint counts in RA Of course, joint count is the most specific measure of RA status. The most specific measure is not necessarily most informative. Poorly reproducible by different observers - must be done by same observer – not GP, infusion, etc. Rigorous formal joint count not performed at most visits

  40. A careful joint examination, rather than a formal joint count may be appropriate for a rheumatology visit.

  41. Radiographs and imaging studies for a rheumatology visit checklist?

  42. 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

  43. TEMPO Trial: Year 2 Radiograph:Change in Total Sharp Score from Baseline to Year 2 3.34 (CI 1.18, 5.50) 1.10* (CI 0.13, 2.07) * p < 0.05, E vs MTX † p < 0.05, Combination vs MTX ‡ p < 0.05, Combination vs E -0.56†‡(CI –1.05, -0.06)

  44. Yazıcı Y, Yazıcı H, Arthritis Rheum 2006;54(supl)

  45. Change in Total Sharp/van der Heijde radiographic scores (0-448) in TEMPO trial over 2 years Van der Heijde A&R2006

  46. RA Cohort #2-Cox Proportional Hazards Model Analyses Including Demographic, Functional, Self-Report, Joint Count, X-ray, Laboratory and Disease Variables in 206 patients 1985-1990 Univariate Stepwise Model RR (95% CL) RR (95% CL) P Value P Value 1.07 <0.001 1.06 <0.001 Age 1.63 <0.001 1.40 0.02 Comorbidity 2.00 0.003 1.76 0.02 MHAQ ADL Score 1.04 0.02 -- -- Disease duration 0.89 0.007 -- -- Education 1.01 0.005 -- -- ESR 1.02 0.10 -- -- Joint count 1.03 0.04 -- -- Walking time 1.40 0.17 -- -- X-ray Callahan, Brooks, Pincus, Arthritis Care Res 10:381,1997

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