1. Yusuf Yazıcı, MD NYU Hospital for Joint Diseases
Implementing Patient Monitoring and Data Collection in Routine Care NYU 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 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. MDHAQ Multi-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)
Constant (Required)
Variable (Encouraged)
Variable (optional)
Physical function
Psychological distress
Review of systems
Pain
Fatigue
Medications
Patient global
Change in status
Recent medical events
AM stiffness
Physician global
RADAI self-report joint count
Physician note
MD joint count

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 test are 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 + DAS28 SDAI CDAI GAS RAPID ACR20 Swollen joints Tender joints
MD global
ESR/CRP
Patient global
Functional score
Pain

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 Jun;30(6): %
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 Feb;48(2): %
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).

54. QUEST-RA (Quantitative Patient Questionnaire Monitoring in Standard Clinical Care of Patients with Rheumatoid Arthritis)
30 rheumatology practices
100 RA patients each
~3000 RA patients
1st phase – cross-sectional
2nd phase – longitudinal
Database creation

55. Conclusion. “A conclusion is the place where you got tired ofthinking”
Conclusion “A conclusion is the place where you got tired ofthinking” Arthur Block
We need to use tools to monitor our patients in routine care
Better medical care, valuable data
Saves time, focuses visits
Saves time!

56. Questions? when I am speaking.
“ I do not object to people looking at their watches
when I am speaking.
But I strongly object when they start shaking them to make certain they are still going.”
Lord Birkett, Observer, Sayings of the Week, 30 October, 1960

57. “We become confident in our educated guesswork to the point where it is easy to confuse personal opinion with evidence, or personal ignorance with scientific uncertainty”
David Naylor, M.D., Ph.D. (1954-)