Implementation of Clinical Measures in Clinical Practice
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Transcript Implementation of Clinical Measures in Clinical Practice
Disease Activity Measurement in
Clinical Practice
Implementation of Clinical Measures in
Patient Care
Speaker, Degree, Meeting Date, Location
Target Audience
This CME activity is intended for practicing
rheumatologists, whether in office based
practice or academic based practice.
There is no fee for participation in this CME
activity.
This program is made possible through
educational grants from Bristol-Myers Squibb and
Abbott Immunology
Accreditation
This activity has been planned and implemented in accordance with
the Essential Areas and policies of the Accreditation Council for
Continuing Medical Education through the joint sponsorship of
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accredited by the ACCME to provide continuing medical education for
physicians.
CMEsolutions designates this educational activity for a maximum of
1.5 AMA PRA Category 1 Credit™. Physicians should only claim credit
commensurate with the extent of their participation in the activity.
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has any commercial interests relevant to the content of
this activity. The content of this CME activity will not
contain discussion of off-label uses. Please consult the
product prescribing information for full disclosure of
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CME Credit Statements
To receive continuing education credit, please complete
the evaluation and credit request form and submit
following the meeting. Credit Statements will be mailed
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Faculty
Faculty Name and Degree
Affiliation
City and State
Dr. XXXX’s Disclosure Statement indicates that she/he
…:
Dr. XXXX also discloses that there will/will not be
discussion of off-label uses of any products during this
presentation.
Objectives
After completing this activity attendees will be able to
1) Describe the utilization of clinical disease assessment tools used to measure
disease activity in rheumatoid arthritis in clinical trials
a. ACR scoring
b. DAS
c. EULAR
2) Describe and utilize patient based/derived measures of disease activity in
rheumatoid arthritis and other rheumatologic conditions
a. MHAQ
b. RAPID 3,4,5
c. S-DAI
d. C-DAI
e. GAS
3) Describe the utilization of laboratory testing for measurement of disease
activity in rheumatoid arthritis
4) Describe the utilization of imaging tools in assessing rheumatoid arthritis
5) Describe data on approaches to disease activity assessment utilized by their
peers in the assessment of disease activity in clinical practice.
Reasons to Assess/Measure Parameters in the
Course of Managing Patients
Assess prognosis
Guide general approach to therapy
Treatment decisions & changes
Documentation – compare patient from visit to visit
Gold Standard Measures
Blood pressure
Total cholesterol
Creatinine
Glucose- Hgb A1C
INR
ESR
CCP
DXA
We can make a diagnosis or decide to implement
or change treatment based upon these tests
Rheumatology:
No “Gold Standard” for Measuring Disease Activity
•
Laboratory tests
•
Imaging
•
Joint counts
Limited Value
Limited if any use for any one of these parameters alone as
basis for making treatment decisions at each office visit
Rheumatology:
Requirements for a “Gold Standard”
Reliable
Accurate
Validated
Predictive Value
Easily and quickly performed
Information immediately accessible
Harmless
Inexpensive
Evidence that Better Patient Outcomes May Be Achieved Using
Disease Activity Measurement To Guide Treatment Decisions
Disease activity measurement :
demonstrated value in management of rheumatoid
arthritis
– TICORA Trial
– BeST Trial
May determine when patients may change/stop
medications1
Van der Bijl AE, et al Arthritis Rheum 56 (7) 2007
Grigor C et al Lancet 364 (263-9( 2004
TICORA (Tight Control in RA) Study Design
Single-blind RCT in RA patients with DAS > 2.4 (N=111)
Intensive care protocol
– Patients assessed monthly
– After 3 mo, oral treatment escalated if DAS 2.4 at monthly assessment
– Physicians were obligated to change therapy based on DAS results
Routine care protocol
– DMARD monotherapy in patients with active synovitis
– Addition of 2nd DMARD at physician discretion
– Patients assessed at 3-mo intervals with no formal composite measure of disease
activity
Endpoints
– Primary outcome
• Mean drop in DAS
• Proportion of patients with good response (DAS < 2.4 and drop in score from
baseline by > 1.2)
– Secondary outcome measures
• Proportion of patients in remission (DAS < 1.6)
• Modified TSS at 18 mo
Grigor C, et al. Lancet. 2004;364:263-269.
TICORA
Clinical Response
100%
80%
Intensive
Group (n=55)
Routine Group
(n=56)
60%
40%
20%
R
E
EU
LA
R
Grigor C,et al. Lancet 2004; 364:263-269
A
C
R
70
A
C
R
50
A
C
R
20
EU
LA
R
G
M
IS
S
O
IO
O
N
D
0%
Intensive Treatment Resulted in Better
Disease Response
DAS Scores
Intensive group (n=53)
6
Disease Activity Score
Routine group (n=50)
5
4
3
2
1
0
0
3
6
9
Month
12
P <0.0001, Intensive vs Routine after month 3.
Grigor C, et al. Lancet. 2004;364:263-269.
15
18
Intensive Treatment Resulted in Better
Radiologic Scores
Intensive
group
(n=53)
Routine
group
(n=50)
P values
Erosion score
0.5
3
0.002
Joint space narrowing
3.25
4.5
0.331
Total Sharp score
4.5
8.5
0.02
Median parameter
Grigor C, et al. Lancet. 2004;364:263-269.
BeSt Trial Study Design
Study design: multicenter, randomized, single-blind,
intent-to-treat (ITT) analysis
Objective: evaluate clinical and radiologic outcomes
after 1 year
N=508 patients with early RA (<2 years by
ACR criteria)
– DMARD naïve
– Baseline demographics similar in all 4 groups
De Vries-Bouwstra JK, et al. ACR 67th Annual Meeting; 2003. Abstract: #LB18.
De Vries-Bouwstra. EULAR 2004 abstract OP0103.
BeSt Trial Protocol/Groups
Protocol/Groups
– Group 1 (n=125): Sequential monotherapy: MTX up to
25 mg/weekSSZ leflunomide
– Group 2 (n=122): Step-up therapy from MTX add SSZ
add hydroxychloroquine
– Group 3 (n=133): Step-down therapy from MTX + SSZ + prednisone 60
mg tapered to 7.5 mg (Initial COBRA Combination)
– Group 4 (n=128): Treatment with MTX (7.5 mg/wk for 2 weeks,
then 15 mg/wk) and infliximab (3 mg/kg at week 0, 2, and 6,
then every 8 weeks), doses increased or reduced to zero depending on
DAS
Change in treatment protocol dictated by 3 monthly determinations
of DAS with goal of DAS ≤ 2.4
– If DAS > 2.4, next step in protocol
– If DAS ≤ 2.4, maintain or taper, according to protocol
De Vries-Bouwstra JK, et al. ACR 67th Annual Meeting; 2003. Abstract: #LB18.
De Vries-Bouwstra. EULAR 2004 abstract OP0103.
Patients in Remission*
% of Patients
80
70
Mono
60
Step-up
All patients discontinued
infliximab at month 9
Combo
50
Anti-TNF
40
30
20
10
0
0
3
6
Month
*Remission indicates DAS < 2.4.
De Vries-Bouwstra JK, et al. Ann Rheum Dis; 2004;63(1):58.
9
12
Outcome in “5th” BeSt group – 1 year
Routine Care (n=201): Early RA patients from Dutch clinics meeting
BeSt criteria
DAS-driven Therapy (n=234): Groups 1 and 2 from BeSt trial – those
on conventional therapy and not biologics
1-year assessment
HAQ
ΔDAS28
ESR
Routine Care
DAS-driven
Therapy
P-value
0.9 0.7
-1.9
19 (6 to 37)
0.7 0.7
-2.7
13 (3 to 28)
0.029
<0.001
0.011
• Conclusion: Intensive therapy achieves better outcomes than routine
care
Goekoop-Ruiterman YPM, et al. ACR, Washington DC 2006, #843
Consistent Use of Measurement Tools:
Better Practice Outcomes
Requirements for recording/reporting of defined measures by 3rd
parties
– Quality Initiatives
– P4P
– Pre-authorization, renewal of approval
Use of consistent measurement improves documentation, and
the ability to justify billing codes and procedures
Van der Bijl AE, et al Arthritis Rheum 56 (7) 2007
Monitoring of RA Care
Informal Surveys of Rheumatologists
How often do you perform in practice?
– Focused joint exam
>90%
– Scored 28 joint exam
<20%
– HAQ (any version)
10-15%
– DAS (any version)
<2%
– Annual radiographs
<10%
Courtesy—Jack Cush, MD
How Do You Assess Efficacy and Need for
Ongoing TNF Inhibitor Therapy?
Response Mean
Physician joint exam
Patient assessment of response
Drug tolerability
Physician global assessment
Radiographic assessments
ESR or CRP
Functional outcome measures
Disease activity score (DAS)
1.69
1.88
2.04
2.14
2.94
3.18
4.20
5.41
*Importance Ranked (1-7); from most important (1) to never important (7) (n=880)
Cush JJ. Ann Rheum Dis. 2005 Nov;64 Suppl 4:iv18-23
How do you Monitor Response/Safety to TNFi in RA
Frequently done (>66%)
96% Vital signs
81% CBC, ESR
88% AM stiffness
83% MD overall assessment
75% Joint exam (Pt focused)
68% CRP
Seldom done (<33%)
Often done (>33<66%)
59% PPD
54% LFTs
52% CRP
51% Yearly hand X-rays
39,51% Pt Global, Pt Pain
39% Symptom survey
33% MD Global Assessment
27% 28 Joint count
20% 66 Joint count
23% Yearly feet X-rays
21% Yearly chest Xray
21% Hepatitis panel
15% HAQ (some version)
16% Rheumatoid factor
12% CCP antibody
23% Urinalysis
5% MRI
1% Ultrasound
6% DAS (some version)
2.8% ACR20(some vers.)
Cush JJ. Ann Rheum Dis. 2005 Nov;64 Suppl 4:iv18-23
Measuring Up:
Chronic Disorders and Assessment Standards
Gestalt
Rheumatoid arthritis*
Osteoarthritis*
Ankylosing spondylitis*
Vasculitis*
Psoriasis*
Multiple sclerosis*
Crohn’s disease*
Quantitative
Osteoporosis
Gout
Lupus
Myositis
COPD/Asthma
NIDDM
HIV
CHF
HTN
* Objective validated outcome
measures exist for RCT;
seldom done in practice
Patient Assessment
Physician Global Assessment: Gestalt
Formal Joint Counts
Lab/Imaging results
– Biomarkers
Categorical Outcomes Measures
– ACR*
Continuous Measurement Tools
– Health Assessment Questionnaire
(HAQ)*
– Disease Activity Score
(DAS)*
– Simplified Disease Activity Index
(SDAI)*
– Clinical Disease Activity Index
(CDAI)*
– Global Arthritis Score
(GAS)*
– Routine Assessment of Patient Index Data (RAPID)*
* Contain patient reported outcome measures
Gestalt: Merriam Webster Definition
Gestalt: a structure, configuration, or pattern of physical,
biological, or psychological phenomena so integrated as
to constitute a functional unit with properties not derivable
by summation of its parts
Gestalt is not a metric – it cannot be used to measure anything
in a way that can be communicated
objectively to another scientist
www.merriam webster.com
Problems with Gestalt as Physician Global
Although high in “efficiency”, Gestalt described as “doing better” or
“doing worse” or “doing a lot better” or “doing a lot worse” is
considered arbitrary by third party payers
No standardization
Should be recorded at every visit –but Gestalt cannot be quantified
Assessing Outcomes
Gestalt
Metrics: DAS, ACR, RAPID,
–
Inter and intra observer variation
–
Not reproducible
–
Can be tracked and graphed
–
Hard to track
–
High inter and intra observer reliability
–
Imprecise
–
“The RAPID 5 improved, dropping from
S and C DAI, GAS, etc
• My patient is doing well
4 to 1”
• My patient isn’t doing very well
–
OK when we really did not want to know
exactly how our patients were doing
–
Now that we might be able to achieve
remission, metrics become important
–
If we measure, we find many patients are
doing measurably better
–
We also identify those whose progress does
not measure up and who need management
changes
Formal Joint Counts in Patient Management
Most specific measure to assess RA
Most important measure in clinical trials
28-joint count as useful in clinical trials as
68–70 joint counts
Limitations of Formal Joint Counts
Joint counts may improve over 5 years while
progressive joint damage and functional disability may
occur *
Joint counts have similar or lower relative efficiencies
than global and patient measures to document
differences between active and control treatments in
clinical trials **
* Arthritis Care Res 10:381-394, 1997
** Arthritis Rheum 48:625-630, 2003. Arthritis Rheum 52:1031-1036, 2005. J Rheumatol 33:2146-2152, 2006, Rheumatology
Limitations of Formal Joint Counts
Joint counts are poorly reproducible*
Rheumatologists perform careful non-quantitative
joint examination, but not formal joint count, at most
visits in usual care**
*Lewis et al. Br J Rheumatol 1988; 27:32. Hart et al. J Rheumatol 1985; 12:716.
Klinkhoff et al. J Rheumatol 1988; 15:492. Thompson et al. J Rheumatol 1991; 18:661.
Kvien et al. Ann Rheum Dis 2005; 64:1480. Scott DL et al. 2006; 15:579.
**Pincus and Segurado, Ann Rheum Dis 65:820-822, 2006
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
25–49% of visits
50–74% of visits
75–99% of visits
Always
32%
11%
14%
16%
14%
Pincus and Segurado,
Ann Rheum Dis 65:820-822,2006.
Imaging in Management of RA
Excellent quantitative x-ray scoring systems
- Sharp, van der Heijde, Larsen, Genant
Reflect cumulative damage of disease
Aid in evaluating treatment response and
decision making
Imaging Concerns
X-ray may be too insensitive to change in structure
MRI may find changes earlier than X-ray
–
Active field of investigation to define significance of findings
–
MRI Changes may be predictive of long term outcomes
Ultrasound –
–
Image surface but not deeper erosions
–
Image synovitis
–
Generally accepted quantifiable measures for assessing disease progression
not yet in place
–
Learning curve
Current studies not always available at visit
– In office access for x-ray- widespread
– In office access to ultrasound and MRI- limited
– Performed at multiple referral sites 2nd to payer requirementslimits side by side comparisons
Laboratory Tests in Management
Rheumatoid Factor(RF) and Anti-CCP diagnostic value
ESR; CRP – reflect inflammation,
–
can be discordant and may not always
correlate with one another
CBC, Chemistries- reflect systemic manifestations
of disease and treatment adverse reactions
CCP = cyclic citrullinated proteins.
Limitations of Laboratory Testing
ESR, CRP normal in 40% at presentation
Anti-CCP & RF negative in 20-50% of patients
Positive tests: reassuring
Negative tests:
–
do not exclude diagnosis of RA
–
do not invariably obviate or exclude need for more aggressive
therapies
Current laboratory values are not always available at visit
Quality a concern – if ESR not done stat but delayed (as could happen if
sent to central reference lab) accuracy and reliability diminished
Measurement Tools
ACR20
Pt Function
Pt Pain
Pt Global
MD Global
TJC
DAS28
SDAI
CDAI
SJC
ESR or CRP
ESR
CRP
GAS RAPID*
(5)
*RAPID – Three Options – RAPID 3; RAPID 4; RAPID 5
** RADAI- information provided entirely by patient
(4)**
ACR Core Data Set
SJC
TJC
Physician Global Assessment
ESR or CRP
Physical Function (HAQ, MHAQ, MDHAQ)
Pain
Patient Global Assessment
Radiographs
ACR 20, 50, 70
Categorical- 20%, 50% or 70% response in core data set measures
– Not a continuous measure
Designed for comparing treatments, response
“Change score” not “activity score”
ACR N?
Hybrid ACR?
Disease Activity Score-28 Joints (DAS28)
DAS28 = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH
DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) +
0.014*GH + 0.96
•
•
•
•
TJC=Tender Joint Count
SJC=Swollen Joint Count
ESR=mm/hr
CRP=mg/l
GH=Patient Global Health Visual Analog (0-100mm)
High Disease Activity>5.1; Low Activity<3.2; Remission<2.6
Available at www. DAS-score.nl
The DAS and DAS28 are not directly interchangeable!
DAS28=1.072(DAS)+0.938
Prevoo ML, et al. Arthritis Rheum 1995; 38: 44-48;
www.das-score.nl
DAS-44
DAS
– Ritchie articular index (0-78)
– SJC (0-44)
– ESR
– Global assessment of disease activity
• ≤2.4 = low
• 2.4<DAS ≤3.7 = moderate
• >3.7 = high
– DAS < 1.6 remission
EULAR response criteria
Current DAS28:
Current DAS
DAS28 < 3.2
Reduction of DAS28:
>1.2
>0.6 and < 1.2
< 0.6
DAS < 2.4
good
moderate
none
3.2 < DAS28 < 5.1
2.4 < DAS28 < 3.7
moderate
moderate
none
DAS28 > 5.1
DAS28 > 3.7
moderate
none
none
Van Gestel et al. Arthritis Rheum. 1998;41(10):1845-50.
DAS Limitations: Requires Laboratory Tests
and Computation
Current lab tests required for calculation often
unavailable at time when DAS needed if to be
considered in management
DAS calculation requires use of specifically designed
calculator or formula available on line
– Perceived to be time consuming
Simplified Disease Activity
Index
SDAI
Tender joint count
(0-28)
Swollen joint count
(0-28)
Patient Global
Assessment (0-10)
Physician Global
Assessment (0-10)
CRP (mg/dl)
>26 High disease
activity
11-26 Moderate
disease
<11 Mild disease
<3.3 Remission
Clin Exp Rheumatol 2005; 23 (Suppl. 39):S100-S108.
Simplified Disease Activity
Index
SDAI
Tender joint count
>26 High disease
(0-28)
activity
Swollen joint count
11-26 Moderate
(0-28)
disease
Patient Global
<11 Mild disease
Assessment (0-10)
<3.3 Remission
Physician Global
Assessment (0-10)
CRP (mg/dl)
Requires formal joint count and laboratory test
Clin Exp Rheumatol 2005; 23 (Suppl. 39):S100-S108.
Clinical Disease Activity
Index CDAI
Tender
joint count
(0-28)
Swollen joint count
(0-28)
Patient Global Assessment (0-10)
Physician Global Assessment (0-10)
– Eliminates ESR/CRP
Aletaha and Smolen Clin Exp Rheumatol 23:S100, 2005.
Clinical Disease Activity
Index CDAI
Tender
joint count
(0-28)
Swollen joint count
(0-28)
Patient Global Assessment (0-10)
Physician Global Assessment (0-10)
– Eliminates ESR/CRP
– Still requires formal joint count
Aletaha and Smolen
Clin Exp Rheumatol 23:S100, 2005.
CDAI Categories – Activity Level
Aletaha and Smolen, 2005
Level
Interpretation
0-2.8
= Remission – therapy is working
2.81–10
= Low - ?? change therapy
10.1–22
= Moderate – consider strongly
change in therapy
22-76
= High - change therapy or
have a good reason not to do so
SDAI and CDAI Advantages and Disadvantages
Relatively easy to calculate
SDAI requires formal joint counts
and laboratory test
CDAI requires formal joint counts
Disease Activity Measures Based
Upon Patient Reported Data
Requirements for Measurement
Tools Incorporating Patient Reports
Validated –reflects disease
activity and predicts outcomes
Reliable
Feasible – easily completed by
patient
– focus on major concerns of
the patient
Saves time for patient and
health professional
Clinically useful – available for
review by MD prior to seeing
patient –that day
Acceptable to MD and patient
Amenable to flow sheet
charting
Recognize under-appreciated
disease severity and patient
concerns
9- to 10-Year Survival According to Quantitative
Markers in Three Chronic Diseases
Pincus T,Callafan LF J Rheumatol 1990:17:1582-585;PincusT,Callahan LF. J Rheumatol 1989:18(S79):67-96;PincusT, Callahan LF, Vaugh WK J Rheumatol 1987: 14:240-251
A
Rheumatoid Arthritis – Activities of Daily Living
B
100
>90%
81%–90%
80
% Active “With Ease”
60
40
71%–80%
Survival (%)
Survival (%)
100
Rheumatoid Arthritis – Formal Education Level
70%
20
>12 Years
80
9–12 Years
60
8 Years
40
20
Months
0
40
60
80
100
0
D
100
Stage I
80
60
Stage II
All Stages,
All Causes
Stage III
Stage IV
40
Hodgkin Disease
Anatomic Stage
20
Survival (%)
Survival (%)
C
20
Months
20
40
60
80
100
100
Coronary Artery
Disease
# Involved Vessels
80
1 Artery
60
2 Arteries
40
3 Arteries
LCA
20
Years
0
2
4
6
8
10
Years
0
2
4
6
8
10
MDHAQ: Multi-Dimensional Health
Assessment Questionnaire
5 scales rated 0-10:
– ADL
– Psychological status
– Pain
– Fatigue
– Global status
HAQ and Multidimensional HAQ (MDHAQ)
HAQ
1st report
Patient completion
No. ADL
Pain VAS
Pt Global VAS
Psych, sleep
RADAI self-report
joint count
Fatigue
Review of systems
Medical history
Demographic data
Social history
Scoring templates
Index
MD scan (“eyeball”)
Time to score
1980
5–10 min
20
10 cm line
10 cm line
No
No
No
No
No
No
No
No
No
30 secs
40 secs
MDHAQ
1999
5–10 min
10
21 circles
21 circles
Sleep, anxiety,
depression
Yes
VAS
60 symptoms
Surgery, side effects
Yes
Yes
Yes
RAPID
5 secs
10 secs
HAQ or MDHAQ: High Predictive Value in RA
• Functional status
• Work disability
• Costs
• Joint replacement surgery
• Death
Pincus et al. Arthritis Rheum. 1984, Wolfe et al. J Rheumatol. 1991
Borg et al. J Rheumatol 1991, Callahan et al. J Clin Epidemiol. 1992, Wolfe and Hawley. J Rheumatol. 1998,
Fex et al. J Rheumatol 1998, Sokka et al. J Rheumatol 1999, Barrett et al. Rheumatology 2000, Puolakka et
al. Ann Rheum Dis 64:130-133, 2005 )
Lubeck et al. Arthritis Rheum. 1986
Wolfe and Zwillich. Arthritis Rheum. 1998
Pincus et al. Arthritis Rheum. 1984, Ann Intern Med.1994, Wolfe et al. J Rheumatol 1988, Leigh&Fries J
Rheumatol 1991, Wolfe et al. Arthritis Rheum. 1994, Callahan et al. Arthrits Care Res 1996, 1997, Soderlin et
al. J Rheumatol 1998, Maiden et al. Ann Rheum Dis 1999, Sokka et al. Ann Rheum Dis 2004)
Global Arthritis Score
Easily and rapidly
obtained at office visits
Correlates with DAS28,
SDAI and CDAI
– Remission ≤3
– Near-remission ≤7
– No value established for
high activity
Validated in small group
practice and large
database (CORRONA)
Cush J, et al. ACR, San Diego 2005, #1854
GAS
Patient pain (0–10)
Raw mHAQ (0–24)
TJC (0–28)
Total 0–62
What Jack Uses
One-Page Pt
Self-Report Form
Global Assessment
Mark or Circle the Joint Pain
That Hurts
Morning Stiffness
Quality of Sleep
Comorbities
Review of Systems
Joint Pain
Pain
ADL - mHAQ
Work/disability
PCP, Health, Exercise
Courtesy of Jack Cush MD.
Global Arthritis Score (GAS):
A Quick Practice Tool for RA Assessment
GAS = TJC (0-28) + Pt Pain (0-10 VAS) + raw mHAQ (0-24)
GAS
mHAQ
GAS vs. DAS28
R =0.88
SJC
60
DAS28
0.88
0.80
0.59
0.63
0.77
SDAI
0.93
0.71
0.78
CDAI
0.90
0.62
0.81
40
GAS
GAS
50
30
20
10
0
-100.02
-20
2.02
4.02
6.02
8.02
DAS-28
GAS Performance (Spearman Rank Correlations) 64 patients; 244 visits
J. Cush, MD ACR 2005
GAS in Practice
No time
No cost
9 Finger addition
Better documentation
One number/measure tracking (flow chart)
Easier communication w/ NP, PA, Colleagues
Data (metric) driven treatment changes
Utility in OA, FM, PsA, Gout, PMR
(not AS, SLE)
Routine Assessment of Patient Index Data
(RAPID)
Mean of the composite score:
– RAPID 3
• MDHAQ (0-10)
• Patient Pain VAS (0-10)
• Patient Global Assessment VAS (0-10)
– RAPID 4
• Adds Patient Reported Joint Count (RADAI) (0-10)
– RAPID 5
• Adds Physician Global Assessment (0-10)
Converts Gestalt into a number!
Pincus T, Yazici Y, Bergman M; JRheum. 2006; 33: 448
Pincus, T, et al. Clin Exp Rheum. 2006; 24: S60
RAPID 3 Scoring Categories
Proposed RAPID 3 Categories Based Upon
RAPID 3 Raw Score Range 0 - 30
<3.0
=
Near Remission – therapy is working
3.01–6
=
Low Severity – begin to consider
change therapy
6.01–12.0
=
Moderate Severity – consider strongly
change in therapy
>12.0
=
High Severity – change therapy or have
a good reason not to do so
The minimally significant change = 3 units.
Studies that provide validation for these categories have been submitted for publication
RAPID Scoring
The RAPID 3 score range is 0 – 30
The RAPID 4 score range is 0 – 40
The RAPID 5 score range is 0 – 50
To bring all RAPID scores into compliance with the suggested disease
activity severity scoring categories, the RAPID 4 and RAPID 5 may be
converted as follows:
– RAPID 4 - divide raw score by 4 and then multiply by 3
– RAPID 5 - divide raw score by 5 and then multiply by 3
Possible RAPID 4 Scoring Categories
Proposed RAPID 4 Categories Based Upon
RAPID 4 Raw Score 0 - 40
<4.0
=
Near Remission – therapy is working
4.01–8
=
Low Severity – begin to consider
change therapy
8.01–16.0
=
Moderate Severity – consider strongly
change in therapy
>16.0
=
High Severity – change therapy or have
a good reason not to do so
The minimally significant change = 4 units.
Studies that provide validation for these categories have been submitted for publication
Possible RAPID 5 Scoring Categories
Proposed RAPID 5 Categories Based Upon
RAPID 5 Raw Score 0 - 50
<5.0
=
Near Remission – therapy is working
5.01–10
=
Low Severity – begin to consider
change therapy
10.01–20.0
=
Moderate Severity – consider strongly
change in therapy
>20.0
=
High Severity – change therapy or have
a good reason not to do so
The minimally significant change = 5 units.
Studies that provide validation for these categories have been submitted for publication
Spearman Correlation Coefficients in 274 Patients with RA – All
p<0.001
(#) = Number of identical measures
Measure
DASvs
CDAI vs
CDAI
0.84 (3)
---
RAPID3
0.66 (1)
0.74 (1)
RAPID4PTJC
0.65 (1)
0.74 (1)
RAPID4MDJC
0.73 (3)
0.83 (3)
RAPID 5
0.69 (1)
0.80 (2)
All results, P <0.001
DAS vs RAPID in AIM Abatacept Trial
DAS28 RAPID2 RAPID3
RAPID
4-MD
RAPID
4-JC
RAPID5
Mean Change ( % )
0%
-10%
-20%
-30%
-21%
-25%
-28%
-27%
-30%
-32%
Control
Abatacept
-40%
-43%
-47%
-50%
-54%
-60%
-52%
-56%
-61%
-70%
Pincus , Maclean, Hines,
Bergman, Yazici,. EULAR. 2007
RAPID can be calculated from data used to calculate DAS
Number of Patients in Remission at Conclusion of 4 Adalimumab
Trials According to DAS28, CDAI, RAPID3, RAPID5
160
140
120
100
ADA
PBO
80
60
40
20
0
DAS28
Pincus, Amara, Segurado,
Bergman, Koch et al ACR 2007
CDAI
RAPID3
RAPID5
RAPID can be calculated from data used to calculate DAS
Resistance to Questionnaires
What are the 3 most important resistance points when implementing patient
questionnaires in standard clinical care? Responses of about 600
rheumatologists on keypads at a meeting to introduce adalimumab to the
European market. Data concerning 3 responses normalized to 100%.
__________________________________________________________
Response Option
Takes too much time
Staff will not cooperate
Patient will not cooperate
No experience – never tried
Don’t know how to interpret results
Measures do not change enough to be helpful
Patient results are not valid results
%
87
63
39
36
33
24
18
Pincus T, Yazici Y, Bergman M, JRheumatol; 2006, 33(3): 448-454
Incorporating Measures into Practice
Commitment to collecting data
– Must be useful
– Must be consistently and rapidly obtained
– Must not interfere with the flow of the practice
– Must be accessible for review during the visit
The “Ten Commandments” of Questionnaires
Use a questionnaire designed for clinical practice, not research
Include “constant” and “variable” fields
Orient the staff to the importance of collecting the data
Complete the questionnaire at every visit
Complete the questionnaire in the waiting room
The “Ten Commandments” of Questionnaires
Have the patient complete the questionnaire, not the staff
Review the results at each visit in front of the patient
Score the results
– Templates help in scoring
Use flow sheets or graphs to track results
Store the results for future reference
– Technology helps, but is not essential
Pincus T, Yazici Y, Bergman M, JRheumatol; 2006, 33(3): 448-454
Using Clinical Data
Regardless of how it is obtained,
Clinical data must be reviewed to be useful
Therapy should be adjusted based on measured
responses
– DAS28<3.2 or DAS < 2.4
– SDAI<22
– GAS<7
– RAPID<2
It Takes Very Little Time to Complete a
Patient Report Based Disease Activity
Measure
Seconds
Mean Time to Score
Pincus T, et al. Abstract #1764 ACR Washington DC 2006
RAPID 3
Rheumatoid Arthritis Disease Activity Index RADAI
Self-Report Joint Count:
Fourth Component for RAPID 4
3. Please place a check (√) in the appropriate spot to indicate the amount of pain you
are having today in each of the joint areas listed below:
None
Mild
Moderate Severe
None
a.LEFT FINGERS
b.LEFT WRIST
c.LEFT ELBOW
d.LEFT SHOULDER
e.LEFT HIP
f.LEFT KNEE
g.LEFT ANKLE
h.LEFT TOES
i.RIGHT FINGERS
j.RIGHT WRIST
k.RIGHT ELBOW
l.RIGHT SHOULDER
m.RIGHT HIP
n.RIGHT KNEE
o.RIGHT ANKLE
p.RIGHT TOES
q.NECK
r.BACK
Stucki G et al. Arthritis Rheum. 1995;38:795-798.
Mild
Moderate Severe
RAPID5 Multidimensional Health Assessment Questionnaire (MDHAQ)
YOUR NAME:______________________________ Date of Birth: _______________ Today’s Date:______________
1.
OVER THE PAST WEEK, were you able to:
Without
ANY
difficulty
□
□
□
□
□
□
□
□
□
□
Dress yourself, including tying shoelaces, doing buttons?
Get in and out of bed?
Lift a full cup or glass to your mouth?
Walk outdoors on flat ground?
Wash and dry your entire body?
Bend down to pick up clothing from the floor?
Turn regular faucets on and off?
Get in and out of a car, bus, train, or airplane?
Walk two miles?
Participate in sports and games as you would like?
2.
□
□
□
□
□
□
□
□
□
□
0
0
0
0
0
0
0
0
0
0
With
MUCH
difficulty
□
□
□
□
□
□
□
□
□
□
1
1
1
1
1
1
1
1
1
1
UNABLE to
do
2
2
2
2
2
2
2
2
2
2
□
□
□
□
□
□
□
□
□
□
3
3
3
3
3
3
3
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
5.5
6
6.5
7
7.5
8
8.5
9
9.5
None
Mild
□0
□0
□0
□0
□0
□0
□0
□0
□0
Moderate Severe
□1
□1
□1
□1
□1
□1
□1
□1
□1
□2
□2
□2
□2
□2
□2
□2
□2
□2
3
RAPID3 0-30
□1
□1
□1
□1
□1
□1
□1
□1
□1
Moderate
□2
□2
□2
□2
□2
□2
□2
□2
□2
Severe
□3
□3
□3
□3
□3
□3
□3
□3
□3
Considering all the ways in which illness and health conditions may affect you at this time,
please indicate below how you are doing:
VERY
WELL
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
5.5
6
6.5
7
7.5
8
8.5
9
9.5
PTGL 0-10
JT CT 0-10
Mild
□0
□0
□0
□0
□0
□0
□0
□0
□0
RIGHT FINGERS
RIGHT WRIST
RIGHT ELBOW
RIGHT SHOULDER
RIGHT HIP
RIGHT KNEE
RIGHT ANKLE
RIGHT TOES
BACK
PN 0-10
3
10
None
□3
□3
□3
□3
□3
□3
□3
□3
□3
16=5.3
17=5.7
18=6.0
19=6.3
20=6.7
21=7.0
22=7.3
23=7.7
24=8.0
25=8.3
26=8.7
27=9.0
28=9.3
29=9.7
30=10
3
Please place a check (√) in the appropriate spot to indicate the amount of pain you are
having today in each of the joint areas listed below:
LEFT FINGERS
LEFT WRIST
LEFT ELBOW
LEFT SHOULDER
LEFT HIP
LEFT KNEE
LEFT ANKLE
LEFT TOES
NECK
1=0.3
2=0.7
3=1.0
4=1.3
5=1.7
6=2.0
7=2.3
8=2.7
9=3.0
10=3.3
11=3.7
12=4.0
13=4.3
14=4.7
15=5.0
PAIN AS BAD AS
IT COULD BE
0
4.
With
SOME
difficulty
How much pain have you had because of your condition OVER THE PAST WEEK?
Please indicate below how severe your pain has been:
NO
PAIN
3.
FN 0-10
Please check () the ONE best answer for your abilities at this time:
10
VERY
POORLY
1=0.2
2=0.4
3=0.6
4=0.8
5=1.0
6=1.3
7=1.5
8=1.7
9=1.9
10=2.1
11=2.3
12=2.5
13=2.7
14=2.9
15=3.1
16=3.3
17=3.5
18=3.8
19=4.0
20=4.2
21=4.4
22=4.6
23=4.8
24=5.0
25=5.2
26=5.4
27=5.6
28=5.8
29=6.0
30=6.3
31=6.4
32=6.7
33=6.9
34=7.1
35=7.3
36=7.5
37=7.7
38=7.9
39=8.1
40=8.3
41=8.5
42=8.8
43=9.0
44=9.2
45=9.4
46=9.6
47=9.8
48=10
RAPID4 0-40
DO NOT WRITE BELOW THIS – FOR DOCTOR’S USE ONLY – MD Global
VERY WELL
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
5.5
6
6.5
7
7.5
8
8.5
9
9.5
VERY POORLY
MDGL:0-10
10
RAPID5 0-50
The Short Distance From Where We
Are To Where We Need To Go
Survey
138
conducted Spring 2007
Surveys Analyzed
Survey 2007
Item
Yes
Swollen Joint Count*
97%
Tender Joint Count*
97%
Morning Stiffness
93%
Medications
91%
Pain*
88%
ESR
86%
Physician Global Assessment*
81%
CRP
79%
Fatigue
77%
Physical exam other than joint exam
76%
Do you record pain on range of motion
75%
Gestalt
70%
Patient Global*
67%
Do you record a numerical value for any variable
49%
*Parameters used to calculate RAPID
Survey 2007
Results of radiographs
39%
HAQ
34%
Is your Gestalt the same for each patient?
31%
MRI
17%
MHAQ
12%
Ultrasound
7%
RAPID
7%
MD HAQ functional score
6%
DAS 28 ( CRP or ESR)
6%
ACR Score
4%
Ritchie Articular Index
3%
GAS
3%
SDAI
1%
CDAI
0%
We are Very Close:
Frequently Measured Parameters that are Included in
the RAPID
Item
Yes
Swollen Joint Count
97%
Tender Joint Count
97%
Pain
88%
Physician Global Assessment
81%
Patient Global
67%
Exercise habits
49%
Depression and anxiety
47%
Strength
47%
Disability status
41%
Benefits of Using Patient Reported
Measures
Standardization enhances consistent data collection
Better reimbursement (level 4,5)
– Review your charts with coding expert
– Custom design your office visit template incorporating data from
PRO
– Patient entered data can be counted in coding process
Pay for Performance
Numeric Flow Charts allow for facile justification of Rx decisions by
3rd party payers
Benefits of Using Patient Reported
Measurements
Better use of waiting room time- patient completes forms while waiting
Replace patient list of symptoms and issues with preformatted list that
“talks to physician”
Provides for consistent data collection
Append serial PROs to treatment authorization requests- answers
payer question of “what is the patient’s ACR score?”
Benefits of Using Patient Reported
Measures
Patient does most of workMD time minimal
Numerical surrogate for response to
management
Focuses visit
Serial results support management
decisions
Physician chooses measurement tool
Consistent recording of information
from visit to visit
– Important for each physician
– Important for communication
between physicians
–
–
Saves time
Avoids wandering discussion
Reminds patient of variables
they may not remember
Objective documentation of
patient status in patient’s own
hand
Limitations of Patient Self-Report Questionnaires
1.
Need for translation –language issues
2.
Cultural and linguistic issues
3.
Possibility of “gaming” by patient, health professional to provide
desired responses
4.
Not specific to any disease
Answers to Objections
Takes too much time
Staff will not cooperate
Patient will not cooperate
No experience – never tried
Don’t know how to interpret results
Measures do not change enough to be
helpful
Patient results are not valid results
Takes 20 seconds and helps to focus
visit
Will staff decline to do vital signs? Make
a DAM a vital sign
Patients positive about completing
form- helps them remember
See one, do one, teach one
You have seen suggested use of
scoring which you will enhance with
experience
Measures do change
Patient reported measures generate
valid results
Conclusions
Patient Outcome Measures are of significant utility to the patient and to the
physician
Utilization requires a commitment on the part of the physician
Data acquisition should be routine and performed on every patient, at every
visit
Once obtained, the data should help “drive” decision-making
Patient collected data is reliable, correlates with other established
measures and IS MOSTLY DONE BY THE PATIENT, THUS SAVING
TIME FOR THE HEALTHCARE TEAM WITHOUT COMPROMISING DATA
CREDIABILITY!
Examples of Forms
RAPID5 Multidimensional Health Assessment Questionnaire (MDHAQ)
YOUR NAME:______________________________ Date of Birth: _______________ Today’s Date:______________
1.
OVER THE PAST WEEK, were you able to:
Without
ANY
difficulty
Get in and out of bed?
Lift a full cup or glass to your mouth?
Walk outdoors on flat ground?
Wash and dry your entire body?
Bend down to pick up clothing from the floor?
Turn regular faucets on and off?
Get in and out of a car, bus, train, or airplane?
Walk two miles?
Participate in sports and games as you would like?
□1
□1
□1
□1
□1
□1
□1
□1
□1
□1
UNABLE to
do
□2
□2
□2
□2
□2
□2
□2
□2
□2
□2
□3
□3
□3
□3
□3
□3
□3
□3
□3
□3
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
5.5
6
6.5
7
7.5
8
8.5
9
None
Mild
□0
□0
□0
□0
□0
□0
□0
□0
□0
Moderate Severe
□1
□1
□1
□1
□1
□1
□1
□1
□1
□2
□2
□2
□2
□2
□2
□2
□2
□2
□0
□0
□0
□0
□0
□0
□0
□0
□0
RIGHT FINGERS
RIGHT WRIST
RIGHT ELBOW
RIGHT SHOULDER
RIGHT HIP
RIGHT KNEE
RIGHT ANKLE
RIGHT TOES
BACK
Mild
□1
□1
□1
□1
□1
□1
□1
□1
□1
Moderate
□2
□2
□2
□2
□2
□2
□2
□2
□2
Severe
□3
□3
□3
□3
□3
□3
□3
□3
□3
Considering all the ways in which illness and health conditions may affect you at this time,
please indicate below how you are doing:
VERY
WELL
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
5.5
6
6.5
7
7.5
8
8.5
9
PN 0-10
PTGL 0-10
JT CT 0-10
9.5 10
None
□3
□3
□3
□3
□3
□3
□3
□3
□3
16=5.3
17=5.7
18=6.0
19=6.3
20=6.7
21=7.0
22=7.3
23=7.7
24=8.0
25=8.3
26=8.7
27=9.0
28=9.3
29=9.7
30=10
RAPID3 0-30
Please place a check (√) in the appropriate spot to indicate the amount of pain you are
having today in each of the joint areas listed below:
LEFT FINGERS
LEFT WRIST
LEFT ELBOW
LEFT SHOULDER
LEFT HIP
LEFT KNEE
LEFT ANKLE
LEFT TOES
NECK
1=0.3
2=0.7
3=1.0
4=1.3
5=1.7
6=2.0
7=2.3
8=2.7
9=3.0
10=3.3
11=3.7
12=4.0
13=4.3
14=4.7
15=5.0
PAIN AS BAD AS
IT COULD BE
0
4.
With
MUCH
difficulty
How much pain have you had because of your condition OVER THE PAST WEEK?
Please indicate below how severe your pain has been:
NO
PAIN
3.
With
SOME
difficulty
□0
□0
□0
□0
□0
□0
□0
□0
□0
□0
Dress yourself, including tying shoelaces, doing buttons?
2.
FN 0-10
Please check () the ONE best answer for your abilities at this time:
9.5 10
VERY
POORLY
1=0.2
2=0.4
3=0.6
4=0.8
5=1.0
6=1.3
7=1.5
8=1.7
9=1.9
10=2.1
11=2.3
12=2.5
13=2.7
14=2.9
15=3.1
16=3.3
17=3.5
18=3.8
19=4.0
20=4.2
21=4.4
22=4.6
23=4.8
24=5.0
25=5.2
26=5.4
27=5.6
28=5.8
29=6.0
30=6.3
31=6.4
32=6.7
33=6.9
34=7.1
35=7.3
36=7.5
37=7.7
38=7.9
39=8.1
40=8.3
41=8.5
42=8.8
43=9.0
44=9.2
45=9.4
46=9.6
47=9.8
48=10
RAPID4 0-40
DO NOT WRITE BELOW THIS – FOR DOCTOR’S USE ONLY – MD Global
VERY WELL
0
0.5
1
1.5
2
2.5
3
3.5 4
4.5
5
5.5
6
6.5
7
7.5
8
8.5
9
VERY POORLY
MDGL:0-10
9.5 10
RAPID5 0-50
5. Please check (√) if you have experienced any of the following over the last month:
__ Fever
__ Lump in your throat
__ Paralysis of arms or legs
__ Weight gain (>10 lbs)
__ Cough
__ Numbness or tingling of arms or legs
__ Weight loss (<10 lbs)
__ Shortness of breath
__ Fainting spells
__ Feeling sickly
__ Wheezing
__ Swelling of hands
__ Headaches
__ Pain in the chest
__ Swelling of ankles
__ Unusual fatigue
__ Heart pounding (palpitations)
__ Swelling in other joints
__ Swollen glands
__ Trouble swallowing
__ Joint pain
__ Loss of appetite
__ Heartburn or stomach gas
__ Back pain
__ Skin rash or hives
__ Stomach pain or cramps
__ Neck pain
__ Unusual bruising or bleeding
__ Nausea
__ Use of drugs not sold in stores
__ Other skin problems
__ Vomiting
__ Smoking cigarettes
__ Loss of hair
__ Constipation
__ More than 2 alcoholic drinks per day
__ Dry eyes
__ Diarrhea
__ Depression - feeling blue
__ Other eye problems
__ Dark or bloody stools
__ Anxiety - feeling nervous
__ Problems with hearing
__ Problems with urination
__ Problems with thinking
__ Ringing in the ears
__ Gynecological (female) problems
__ Problems with memory
__ Stuffy nose
__ Dizziness
__ Problems with sleeping
__ Sores in the mouth
__ Losing your balance
__ Sexual problems
__ Dry mouth
__ Muscle pain, aches, or cramps
__ Burning in sex organs
__ Problems with smell or taste
__ Muscle weakness
__ Problems with social activities
6. When you awakened in the morning OVER THE LAST WEEK, did you feel stiff? �No �Yes
If “No,” please go to Item 7. If “Yes,” please indicate the number of minutes_______, or hours _____
until you are as limber as you will be for the day.
7. How do you feel TODAY compared to ONE WEEK AGO? Please check (�) only one.
Much Better � (1), Better � (2), the Same � (3), Worse � (4), Much Worse � (5) than one week ago
8. How often do you exercise aerobically (sweating, increased heart rate, shortness of breath) for at least
one-half hour (30 minutes)? Please check (�) only one.
� 3 or more times a week (3) � 1-2 times per month (1)
� 1-2 times per week (2)
� Do not exercise regularly (0) � Cannot exercise due to disability/ handicap (9)
9. How much of a problem has UNUSUAL fatigue or tiredness been for you OVER THE PAST WEEK?
FATIGUE IS � � � � � � � � � � � � � � � � � � � � �
FATIGUE IS A
NO PROBLEM 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 MAJOR PROBLEM
10. Over the last 6 months have you had: [Please check (√)]
�No �Yes An operation
�No �Yes
�No �Yes Inpatient hospitalization
�No �Yes
�No �Yes A new illness, accident or trauma
�No �Yes
�No �Yes An important new symptom
�No �Yes
�No �Yes Side effect(s) of any drug
�No �Yes
�No �Yes Smoke cigarettes regularly
�No �Yes
Change(s) of arthritis drugs or other drugs
Change(s) of address
Change(s) of marital status
Change job or work duties, quit work, retired
Change of medical insurance, Medicare, etc.
Change of primary care or other doctor
Please explain any "Yes" answer below, or indicate any other health matter that affects you:
____________________________________________________________
____________________________________________________________
SEX: � Female, � Male
ETHNIC GROUP: � Asian, � Black, � Hispanic, � White, � Other______________
Your Occupation __________________________
Circle the number of years of school you have completed:
1 2 3 4 5 6 7 8 9 10
11 12 13 14 15 16 17 18 19 20
Work Status: � Full-time � Part-time � Disabled
� Homemaker � Self-Employed �Retired
� Seeking work � Other_____________________ Record your weight: _____ lbs. height: _____ inches
Your Name_____________________________________ Date of Birth ___________ Today’s Date ___________
Thank you for completing this questionnaire to help keep track of your medical care
Symptom Checklist From MDHAQ
Please check (√) if you have experienced any of the following
over the last month:
__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
__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
Recent Medical History – Self-report
Over the last 6 months have you had [please check (√)]:
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
An operation
Inpatient hospitalization
A new illness, accident or trauma
An important new symptom
Side effect(s) of any drug
Cigarettes regularly
Change(s) of arthritis drugs or other drugs
Change of address
Change of marital status
Change of job or work duties, quit work, retired
Change of medical insurance, Medicare, etc.
Change of primary care or other doctor
Please explain any “yes" answer below, or indicate any
other health matter that affects you:
___________________________________________________________
HAQ, Pt Global, ROS, Meds, MD Global