Transcript Slide 1

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
Monitoring outcomes
in routine care
• Why?
• What do we do now?
• How can we do it?
• Our experience
• Private practice
• Academic center
Tight control
of disease
activity –
TICORA study
Grigor et al, Lancet 2004
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 Xray damage.
Pincus, Segurado. Ann Rheum Dis 2006
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
Other diseases
• HTN – Blood pressure
• Hyperlipidemia - Cholesterol
• Thyroid - TSH
• What does the rheumatologist have?
VAS clustering
Clustering
18%
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16%
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14%
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10%
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Format 7
Format 8
Format 9
8%
Format 10
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6%
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4%
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2%
0%
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5
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5
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9.
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10
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Percent
12%
* denotes square
Value
Pincus T, Sokka T. Ann Rheum Dis 2004
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.
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
Time to score
Mean Time to Score
120
100
Seconds
80
60
40
20
0
28 Joint
Count
DAS 28 – HAQ FN
enter
+ PN, GL
numbers
VAS
Rheum #1
84
12.9
41.5
Rheum #2
113
16.8
42.2
Rheum #3
71
14.6
Mean of Rheum #1 #2 #3
90
14.6
41.9
HAQ –
VAS
MDHAQ
FN + PN,
GL VAS
RAPID2
RAPID 3 = RAPID
RAPID
FN, PN, 4MD=RAP 4JC =
RAPID 5
GL
ID 3+MD RAPID 3 +
6.4
4.3
9.2
11.8
19
19.4
23.9
8.5
4.4
12.1
16.1
22.8
27.3
24.1
7.5
4
9.1
12
15.3
17.5
24
7.5
4.3
9.6
12.2
19
19.4
Format
Practical considerations in use of
MDHAQ, patient questionnaires (1)
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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
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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
Practical considerations in use of MDHAQ
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(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
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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
Practical considerations in use of MDHAQ
• 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,
(3)
Practical considerations in use of MDHAQ
• 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
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• 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
(4)
Practical considerations in use of MDHAQ
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
(5)
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
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 longterm outcomes in RA
• Functional status1
• Work disability2
• Costs3
• Joint replacement surgery4
• Premature death5
1
Pincus et al, A&R 1984
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
2 Sokka
Patient–reported outcomes
Strand et al, Rheumatology 2004
Indices
Swollen joints
Tender joints
DAS28
SDAI
CDAI
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MD global
ESR/CRP
Patient global
Functional score
Pain
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GAS RAPID ACR20
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Routine care
• Why collect data?
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
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
“real world” patients
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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%
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Eligibility of patients in routine care for major clinical trials of antitumor necrosis factor alpha agents in rheumatoid arthritis.
Sokka T, Pincus T. Arthritis Rheum. 2003 Feb;48(2):313-8. 7%
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Eligibility for inclusion criteria in use for rheumatoid arthritis clinical
trials in a Turkish cohort. F. Göğüş, Y. Yazıcı, H Yazıcı (ACR 2003) 6%
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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%
BOARD
Brooklyn Outcomes of Arthritis Registry Database
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
BOARD
BOARD
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
162 RA patients from BOARD
0
SJC
1
-5
TJC
-4 -4 -3
-10
-7
-9
Pain
-15
Patient global
-20
-17
-18 -19
Fatigue
mHAQ
-25
-27
-30
-45
Morning stiffness
MD global
-35
-40
ESR
DAS28
-37 -36
CDAI
-41
RAPID
HJD ARMD
Arthritis Registry Monitoring Database
ARMD
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September 2005 at NYU-Hospital for Joint Diseases
Each patient multidimensional health assessment questionnaire
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English and Spanish.
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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.
ARMD
(2)
• September 2005 to January 2006, 513 patients were
enrolled,
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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).
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
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!
Questions?
“ 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
“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-)