Yusuf Yazıcı, MD NYU Hospital for Joint Diseases

1. Implementing Patient Monitoring and Data Collection in Routine CareNYU Hospital for Joint Diseases Arthritis Registry Monitoring Database (ARMD) &Brooklyn Outcomes of Arthritis Registry Database (BOARD) Yusuf Yazıcı, MD NYU Hospital for Joint Diseases

2. Monitoring outcomes in routine care • Why? • What do we do now? • How can we do it? • Our experience • Private practice • Academic center

3. Tight control of disease activity – TICORA study

4. Grigor et al, Lancet 2004

6. Monitoring RA patients • How do rheumatologists follow patients? • In the US, < 10% use questionnaires in routine clinical care • <15% do a joint count at each visit • Treatment decisions made on ESR/CRP values, x-rays? • At initial presentation, 40% of patients have normal ESR or CRP, 30% have no RF, and the best treatment is before X-ray damage. Pincus, Segurado. Ann Rheum Dis 2006

7. Measurement • Most rheumatologists suggest they can recognize extent of pain and disability without questionnaires to provide quantitative data • They are correct • You can also recognize fever or tachycardia without formally measuring temperature or heart rate • Who would accept this kind of management? Pincus, Yazici, Bergman, J Rheumatol 2006

8. Other diseases • HTN – Blood pressure • Hyperlipidemia - Cholesterol • Thyroid - TSH • What does the rheumatologist have?

10. VAS clustering

12. Pincus T, Sokka T. Ann Rheum Dis 2004

13. Questionnaires for standard care must be: • Completed by most patients in 5-10 minutes • Scanned by a clinician in 5-10 seconds • Designed to facilitate scoring, template on questionnaire • Scored and entered into flow sheet in 10-20 seconds • Informative for patients in all rheumatic diseases • All the work done by the patient; physician or staff do minimal work, spend few seconds.

14. MDHAQMulti-Dimensional Health Assessment Questionnaire • 10 ADL: overcome floor effects; normal scores in 688 patients: MHAQ 23%, HAQ 15%, MDHAQ 7% • Review of systems • Distributed at each YY visit of each patient since 2001 • Useful in all rheumatic diseases • Used in conjunction with simple flow sheet - 3 types of data: questionnaire scores, lab data, drugs

16. Time to score

17. Practical considerations in use of MDHAQ, patient questionnaires (1) • Use a questionnaire designed for standard care, not for research • Although the information is often useful for research • Just as differences between antiCCP measurement in clinical care and research differ, no need for lengthy research questionnaires • Orient staff regarding the importance of patient questionnaires in patients care, and mean it • If rationale presented as for research, documentation, reimbursement, collaboration with colleagues, any other reason than better and more efficient patient care, it won’t work

18. Practical considerations in use of MDHAQ (2) • Questionnaires should be part of office infrastructure, completed by every patient, with any diagnosis, every visit. • Only efficient distribution system • Impossible to organize front desk to identify patient, identify intervals for questionnaire distribution • MDHAQ is useful for all patients with all rheumatic diseases* • Data only at periodic intervals may miss important changes • If there is a reason for a visit, there is a reason for a questionnaire * Callahan et al. Arthritis Care Res 1989

19. Practical considerations in use of MDHAQ (3) • Questionnaires should ideally be completed in the waiting room, not the exam room • Most patients spend 10 minutes in the waiting room • An opportunity for the patient to focus on problems • Let the patients do the work; office staff should do as little as possible • Function, pain, fatigue, global status are reported more accurately by patient self report than physicians1 • Only a single observer v second observer • Reproducibility increased2 1 Fries et al, A&R 1980, 2Callahan 1988,

20. Practical considerations in use of MDHAQ (4) • Clinician should review the questionnaire with the patient • Most factual information that would require Q&A is eyeballed in 5 seconds • Scoring template on the questionnaire • RAPID, 0-10 VAS, 0-3, or 0-10 function • Flow sheets can be very useful • Entry into a flow sheet allows for tracking trend • Database output • No computer is required; do not overuse technology • Nothing is as cheap, available, and easy to use as pen/pencil and paper

21. Practical considerations in use of MDHAQ (5)

22. Things to remember • Data may be influenced by nonspecific factors • So is ESR, so is pain • MDHAQ never replaces a careful history and physical examination, data always need to be interpreted • All data needs to be put into perspective

23. Patient Questionnaires • Most informative quantitative data for patient status from one visit to the next • Patient questionnaires not a joint count, radiographic score or laboratory testare the most significant predictors of all severe long-term outcomes in RA • Functional status1 • Work disability2 • Costs3 • Joint replacement surgery4 • Premature death5 1 Pincus et al, A&R 1984 2 Sokka et al, J Rheumatol 1999 3 Luback et al, A&R 1986, 4 Wolfe et al, A&R 1998, 5 Sokka et al, Ann Rheum Dis 2004

24. Patient–reported outcomes Strand et al, Rheumatology 2004

27. Indices

28. Routine care • Why collect data?

29. Randomized Controlled Clinical Trials 1. Foundation for evaluation of therapies 2. Meet criteria for scientific experiment 3. Only method for study patients not selected for therapies 4. Nonetheless, includes many limitations, and provides only the first stage of evaluation of therapies

30. Some Practical Limitations of Randomized Clinical Trials • Patient selection: exclusion criteria – • only a small minority in trials, e.g., RA in 2001 • Statistically significant results not necessarily clinically important, e.g., ?ACR 20 response • Short observation period in chronic diseases • Inflexible dosage schedules and other drugs • Surrogate markers not necessarily clinically relevant Pincus and Stein. Clin Exp Rheumatol. 1997;15:S27

31. “real world” patients • Most patients receiving routine care for rheumatoid arthritis in 2001 did not meet inclusion criteria for most recent clinical trials or American college of rheumatology criteria for remission. Sokka T, Pincus T. J Rheumatol. 2003 Jun;30(6):1138-46 11% • Eligibility of patients in routine care for major clinical trials of anti-tumor necrosis factor alpha agents in rheumatoid arthritis. Sokka T, Pincus T. Arthritis Rheum. 2003 Feb;48(2):313-8. 7% • Eligibility for inclusion criteria in use for rheumatoid arthritis clinical trials in a Turkish cohort.F. Göğüş, Y. Yazıcı, H Yazıcı(ACR 2003)6% • Majority of rheumatoid arthritis (RA) patients in routine care do not meet inclusion criteria for RA clinical trials. I. Kulman, Y. Yazıcı (EULAR 2004) 5%

32. BOARD Brooklyn Outcomes of Arthritis Registry Database

33. Brooklyn Outcomes of Arthritis Registry Database (BOARD) • Since April 2001 • ~2200 patients • ~200 RA • ~150 SLE • A lot of OA • >19,000 data points (visits) Yazici, Clin Expr Rheumatol, 2005

36. BOARD

37. BOARD

38. BOARD Publications • Racial/ethnic differences among early RA patients • Use of ESR/CRP and correlation with outcomes in RA, SLE, OA patients • MTX efficacy and side effects in RA patients • RAPID/DAS28/CDAI correlation among RA patients

39. 162 RA patients from BOARD

40. HJD ARMD Arthritis Registry Monitoring Database

41. ARMD • September 2005 at NYU-Hospital for Joint Diseases • Each patient multidimensional health assessment questionnaire • functional status • pain • fatigue • patient global assessment of disease activity • RADAI patient self joint count • morning stiffness • questions about current medications • work status • medical and surgical problems since last visit • 60-question symptoms list • comorbitidies • exercise habits • demographic information. • English and Spanish.

42. ARMD (2) • September 2005 to January 2006, 513 patients were enrolled, • 344 from the hospital clinics • 169 from private offices • 400 (78%) female • 253 (49%) Hispanic (white=104, African American=52, Asian=34, others=70). • Mean age was 53 ± 15. • 374 patients used the English version of the forms (73%). • The most common 3 diagnosis were rheumatoid arthritis (n=235), osteoarthritis (n=47) and SLE (n=25). • When individual items were analyzed, the completion rate ranged from 88% (current medications) to 99% (MDHAQ).