Implementation of Clinical Measures in Patient Care

1
Implementation of Clinical Measures in Patient
Care
Disease Activity Measurement in Clinical Practice

• Speaker, Degree, Meeting Date, Location

2
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
3
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 CMEsolutions and Miller Professional
  Consulting. CMEsolutions is 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.

4
Disclosure of Significant Relationships with
Relevant Commercial Interests

• Neither CMEsolutions nor Miller Professional
  Consulting 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
  labeled uses.

5
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 within two weeks of
  activity completion.

6
Faculty

• Faculty Name and Degree
• Affiliation
• City and State

Dr. XXXXs 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.
7
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 arthritis5) Describe
  data on approaches to disease activity assessment
  utilized by their
• peers in the assessment of disease
  activity in clinical practice.

8
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

9
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
10
Rheumatology No Gold Standard for Measuring
Disease Activity

• Laboratory tests
• Imaging Limited
  Value
• Joint counts

Limited if any use for any one of these
parameters alone as basis for making treatment
decisions at each office visit
11
Rheumatology Requirements for a Gold Standard
Reliable Accurate Validated Predictive
Value Easily and quickly performed Information
immediately accessible Harmless Inexpensive
12
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
13
TICORA (Tight Control in RA) Study Design

• Single-blind RCT in RA patients with DAS gt 2.4
  (N111)
• 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 lt
  2.4 and drop in score from baseline by gt 1.2)
• Secondary outcome measures
• Proportion of patients in remission (DAS lt 1.6)
• Modified TSS at 18 mo

Grigor C, et al. Lancet. 2004364263-269.
14
TICORA
Clinical Response
Grigor C,et al. Lancet 2004 364263-269
15
Intensive Treatment Resulted in Better Disease
Response
DAS Scores
6
5
4
Disease Activity Score
3
2
1
0
0
3
6
9
12
15
18
Month
P lt0.0001, Intensive vs Routine after month
3. Grigor C, et al. Lancet. 2004364263-269.
16
Intensive Treatment Resulted in Better
Radiologic Scores
Median parameter Intensivegroup(n53) Routinegroup(n50) 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
Grigor C, et al. Lancet. 2004364263-269.
17
BeSt Trial Study Design

• Study design multicenter, randomized,
  single-blind, intent-to-treat (ITT) analysis
• Objective evaluate clinical and radiologic
  outcomesafter 1 year
• N508 patients with early RA (lt2 years byACR
  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.
18
BeSt Trial Protocol/Groups

• Protocol/Groups
• Group 1 (n125) Sequential monotherapy MTX up
  to 25 mg/week?SSZ ?leflunomide
• Group 2 (n122) Step-up therapy from MTX ? add
  SSZ ?add hydroxychloroquine
• Group 3 (n133) Step-down therapy from MTX SSZ
  prednisone 60 mg tapered to 7.5 mg (Initial
  COBRA Combination)
• Group 4 (n128) 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 determinationsof DAS with goal of DAS
  2.4
• If DAS gt 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.
19
Patients in Remission
80 70 60 50 40 30 20 10 0
All patients discontinued infliximab at month 9
of Patients
0
3
6
9
12
Month
Remission indicates DAS lt 2.4. De Vries-Bouwstra
JK, et al. Ann Rheum Dis 200463(1)58.
20
Initial Treatment With Regimens Containing
Biologic DMARDs Results in Less Radiographic
Progression
Group 1 Group 2 Group 3 Group 4
  Sequential Mono Tx n125 Step-UpCombo Txn122 InitialCOBRACombo Txn133 InitialMTX Infliximabn128 P value
HAQ (mean change) 0.7 0.7 0.9 0.9 0.040
SHS progression (median) 2.0 2.5 1.0 .5 lt0.001
No SHS progression () 27 29 37 46 0.007
Discontinuation lt1 year (n) 5 6 6 2 0.494
Serious AEs (n) 3 5 13 6 0.160
Pt would choose therapy 36 30 41 81
P value MTX infliximab versus sequential
monotherapy or step-up combination therapy.
SHS indicates Sharp/van der Heijde
radiographic score. De Vries-Bouwstra JK, et
al. ACR 67th Annual Meeting, 2003 Abstract
LB18. De Vries-Bouwstra. EULAR 2004 abstract
OP0103 De Vries-Bouwstra. EULAR 2004 abstract
OP0001.
21
Outcome in 5th BeSt group 1 year

• Routine Care (n201) Early RA patients from
  Dutch clinics meeting BeSt criteria
• DAS-driven Therapy (n234) Groups 1 and 2 from
  BeSt trial those on conventional therapy and
  not biologics

1-year assessment Routine Care DAS-driven Therapy P-value
HAQ 0.9 ? 0.7 0.7 ? 0.7 0.029
?DAS28 -1.9 -2.7 lt0.001
ESR 19 (6 to 37) 13 (3 to 28) 0.011

• Conclusion Intensive therapy achieves better
  outcomes than routine care

Goekoop-Ruiterman YPM, et al. ACR, Washington DC
2006, 843
22
Consistent Use of Measurement ToolsBetter
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
23
Monitoring of RA CareInformal Surveys of
Rheumatologists

• How often do you perform in practice?
• Focused joint exam gt90
• Scored 28 joint exam lt20
• HAQ (any version) 10-15
• DAS (any version) lt2
• Annual radiographs lt10

CourtesyJack Cush, MD
24
How Do You Assess Efficacy and Need for Ongoing
TNF Inhibitor Therapy?
Response Mean
Physician joint exam 1.69
Patient assessment of response 1.88
Drug tolerability 2.04
Physician global assessment 2.14
Radiographic assessments 2.94
ESR or CRP 3.18
Functional outcome measures 4.20
Disease activity score (DAS) 5.41
Importance Ranked (1-7) from most important (1)
to never important (7) (n880)
Cush JJ. Ann Rheum Dis. 2005 Nov64 Suppl
4iv18-23
25
How do you Monitor Response/Safety to TNFi in RA

• Frequently done (gt66)
• 96 Vital signs
• 81 CBC, ESR
• 88 AM stiffness
• 83 MD overall assessment
• 75 Joint exam (Pt focused)
• 68 CRP

• Seldom done (lt33)
• 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.)

• Often done (gt33lt66)
• 59 PPD
• 54 LFTs
• 52 CRP
• 51 Yearly hand X-rays
• 39,51 Pt Global, Pt Pain
• 39 Symptom survey
• 33 MD Global Assessment

Cush JJ. Ann Rheum Dis. 2005 Nov64 Suppl
4iv18-23
26
Measuring UpChronic Disorders and Assessment
Standards

• Gestalt
• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Vasculitis
• Psoriasis
• Multiple sclerosis
• Crohns disease

• Quantitative
• Osteoporosis
• Gout
• Lupus
• Myositis
• COPD/Asthma
• NIDDM
• HIV
• CHF
• HTN

Objective validated outcome measures exist for
RCT seldom done in practice
27
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

28
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
29
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

30
Assessing Outcomes

• Gestalt
• Inter and intra observer variation
• Not reproducible
• Hard to track
• Imprecise
• My patient is doing well
• My patient isnt doing very well
• OK when we really did not want to know exactly
  how our patients were doing

• Metrics DAS, ACR, RAPID,
• S and C DAI, GAS, etc
• Can be tracked and graphed
• High inter and intra observer reliability
• The RAPID 5 improved, dropping from
• 4 to 1
• 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

31
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
  6870 joint counts

32
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 10381-394, 1997
• Arthritis Rheum 48625-630, 2003.
  Arthritis Rheum 521031-1036, 2005. J Rheumatol
  332146-2152, 2006, Rheumatology

33
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 2732. Hart et
  al. J Rheumatol 1985 12716.
• Klinkhoff et al. J Rheumatol 1988 15492.
  Thompson et al. J Rheumatol 1991 18661.
• Kvien et al. Ann Rheum Dis 2005 641480. Scott
  DL et al. 2006 15579.
• Pincus and Segurado, Ann Rheum Dis 65820-822,
  2006

34
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
124 of visits
32
2549 of visits
11
5074 of visits
14
7599 of visits
16
Always
Pincus and Segurado, Ann Rheum Dis
65820-822,2006.
14
35
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

36
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
  requirements-
• limits side by side comparisons

37
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.
38
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

39
Measurement Tools
ACR20 DAS28 SDAI CDAI GAS RAPID
Pt Function ? ? ?
Pt Pain ? ? ?
Pt Global ? ? ? ? ?
MD Global ? ? ? (5)
TJC ? ? ? ? ? (4)
SJC ? ? ? ?
ESR or CRP ? ? ESR ? CRP
RAPID Three Options RAPID 3
RAPID 4 RAPID 5 RADAI- information provided
entirely by patient
40
ACR Core Data Set

• SJC
• TJC
• Physician Global Assessment
• ESR or CRP
• Physical Function (HAQ, MHAQ, MDHAQ)
• Pain
• Patient Global Assessment
• Radiographs

41
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?

42
Disease Activity Score-28 Joints (DAS28)

• DAS28 0.56sqrt(t28) 0.28sqrt(sw28)
  0.70Ln(ESR) 0.014GH
• DAS28-CRP 0.56sqrt(TJC28) 0.28sqrt(SJC28)
  0.36ln(CRP1) 0.014GH 0.96
• TJCTender Joint Count
• SJCSwollen Joint Count
• ESRmm/hr CRPmg/l
• GHPatient Global Health Visual Analog (0-100mm)
• High Disease Activitygt5.1 Low Activitylt3.2
  Remissionlt2.6
• Available at www. DAS-score.nl
• The DAS and DAS28 are not directly
  interchangeable!
• DAS281.072(DAS)0.938

Prevoo ML, et al. Arthritis Rheum 1995 38
44-48
www.das-score.nl
43
DAS-44

• DAS
• Ritchie articular index (0-78)
• SJC (0-44)
• ESR
• Global assessment of disease activity
• 2.4 low
• 2.4ltDAS 3.7 moderate
• gt3.7 high
• DAS lt 1.6 remission

44
EULAR response criteria
Current DAS28 Current DAS Reduction of DAS28 Reduction of DAS28 Reduction of DAS28
Current DAS28 Current DAS gt1.2 gt0.6 and lt 1.2 lt 0.6
DAS28 lt 3.2 DAS lt 2.4 good moderate none
3.2 lt DAS28 lt 5.1 2.4 lt DAS28 lt 3.7 moderate moderate none
DAS28 gt 5.1 DAS28 gt 3.7 moderate none none
Van Gestel et al. Arthritis Rheum.
199841(10)1845-50.
45
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

46
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)

• gt26 High disease activity
• 11-26 Moderate disease
• lt11 Mild disease
• lt3.3 Remission

Clin Exp Rheumatol 2005 23 (Suppl. 39)S100-S108.
47
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)

• gt26 High disease activity
• 11-26 Moderate disease
• lt11 Mild disease
• lt3.3 Remission

Requires formal joint count and laboratory test
Clin Exp Rheumatol 2005 23 (Suppl. 39)S100-S108.
48
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 23S100,
  2005.

49
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 23S100,
  2005.

50
CDAI Categories Activity Level Aletaha and
Smolen, 2005
Level Interpretation 0-2.8 Remission
therapy is working 2.8110 Low - ?? change
therapy 10.122 Moderate consider strongly
change in therapy 22-76 High - change
therapy or have a good reason not to do
so
51
SDAI and CDAI Advantages and Disadvantages

• Relatively easy to calculate
• SDAI requires formal joint counts and laboratory
  test
• CDAI requires formal joint counts

52
Disease Activity Measures Based Upon Patient
Reported Data
53
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

54
9- to 10-Year Survival According to Quantitative
Markers in Three Chronic Diseases
Pincus T,Callafan LF J Rheumatol
1990171582-585PincusT,Callahan LF. J Rheumatol
198918(S79)67-96PincusT, Callahan LF, Vaugh WK
J Rheumatol 1987 14240-251
Rheumatoid Arthritis Activities of Daily Living
Rheumatoid Arthritis Formal Education Level
B
A
100
100
gt12 Years
gt90
80
8190
80
912 Years
Active With Ease
60
60
8 Years
Survival ()
Survival ()
40
40
7180
20
20
70
Months
Months
0
20
40
60
80
100
0
20
40
60
80
100
C
D
100
100
Coronary Artery Disease Involved Vessels
Hodgkin Disease Anatomic Stage
Stage I
80
80
1 Artery
Stage II
60
60
Stage III
All Stages, All Causes
Survival ()
Survival ()
2 Arteries
Stage IV
40
40
3 Arteries
20
20
LCA
Years
Years
0
2
4
6
8
10
0
2
4
6
8
10
55
MDHAQ Multi-Dimensional Health Assessment
Questionnaire

• 5 scales rated 0-10
• ADL
• Psychological status
• Pain
• Fatigue
• Global status

56
HAQ and Multidimensional HAQ (MDHAQ)

• HAQ MDHAQ
• 1st report 1980 1999
• Patient completion 510 min 510 min
• No. ADL 20 10
• Pain VAS 10 cm line 21 circles
• Pt Global VAS 10 cm line 21 circles
• Psych, sleep No Sleep, anxiety,
  depressionRADAI self-report joint
  count No Yes
• Fatigue No VAS
• Review of systems No 60 symptoms
• Medical history No
  Surgery, side effects
• Demographic data No Yes
• Social history No Yes
• Scoring templates No Yes
• Index No RAPID
• MD scan (eyeball) 30 secs 5 secs
• Time to score 40 secs 10
  secs

57
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
  64130-133, 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,
  LeighFries 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)

58
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)

GAS
Patient pain (010) Raw mHAQ (024) TJC (028)
Total 062
Cush J, et al. ACR, San Diego 2005, 1854
59
What Jack UsesOne-Page Pt Self-Report Form
Global Assessment
Morning Stiffness
Quality of Sleep
Comorbities
Review of Systems
Joint Pain
Pain
ADL - mHAQ
Work/disability
PCP, Health, Exercise
Courtesy of Jack Cush MD.
60
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 vs. DAS28 R 0.88
GAS mHAQ SJC
GAS - 0.80 0.63
DAS28 0.88 0.59 0.77
SDAI 0.93 0.71 0.78
CDAI 0.90 0.62 0.81
GAS Performance (Spearman Rank Correlations) 64
patients 244 visits
J. Cush, MD ACR 2005
61
Global Arthritis Score (GAS A Rapid Practice
Tool for Rheumatoid Arthritis (RA) Assessment.
DAS28 DAS CRP SDAI CDAI mHAQ MD Glob SJC CRP
GAS 0.88 0.91 0.93 0.90 0.80 0.73 0.63 0.42
DAS 28 - 0.95 0.94 0.91 0.59 0.71 0.77 0.47
SDAI - - - 0.98 0.71 0.83 0.78 0.52
CDAI - 0.62 0.83 0.81 0.40
GAS Performance (Spearman Rank Correlations) All
patients all visits (n244)
62
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)

63
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
64
RAPID 3 Scoring Categories
Proposed RAPID 3 Categories Based Upon
RAPID 3 Raw Score Range 0 - 30
lt3.0 Near Remission
therapy is working 3.016 Low Severity
begin to consider change
therapy 6.0112.0 Moderate Severity consider
strongly change in therapy gt12.0 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
65
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

66
Possible RAPID 4 Scoring Categories
Proposed RAPID 4 Categories Based Upon
RAPID 4 Raw Score 0 - 40
lt4.0 Near Remission
therapy is working 4.018 Low Severity
begin to consider change
therapy 8.0116.0 Moderate Severity consider
strongly change in therapy gt16.0 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
67
Possible RAPID 5 Scoring Categories
Proposed RAPID 5 Categories Based Upon
RAPID 5 Raw Score 0 -
50
lt5.0 Near Remission therapy is
working 5.0110 Low Severity begin to
consider change therapy 10.0120.0 Moder
ate Severity consider strongly change in
therapy gt20.0 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
68
Spearman Correlation Coefficients in 274 Patients
with RA All plt0.001() 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 lt0.001
69
DAS vs RAPID in AIM Abatacept Trial
RAPID 4-MD
RAPID 4-JC
RAPID2
RAPID3
RAPID5
DAS28
0
-10
-20
-21
Mean Change ( )
-25
-27
-30
-28
Control
-30
-32
Abatacept
-40
-43
-47
-50
-52
-54
-56
-60
-61
-70

RAPID can be calculated from data used to
calculate DAS
Pincus , Maclean, Hines, Bergman, Yazici,.
EULAR. 2007
70
Number of Patients in Remission at Conclusion of
4 Adalimumab Trials According to DAS28, CDAI,
RAPID3, RAPID5
RAPID can be calculated from data used to
calculate DAS
Pincus, Amara, Segurado, Bergman, Koch et al ACR
2007
71
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
  87
• Staff will not cooperate 63
• Patient will not cooperate
  39
• No experience never tried
  36
• Dont know how to interpret results
  33
• Measures do not change enough to be helpful
  24
• Patient results are not valid results
  18

Pincus T, Yazici Y, Bergman M, JRheumatol 2006,
33(3) 448-454
72
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

73
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

74
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
75
Methods of Documentation

• Desktop/Laptop
• Entered directly into chart by patient
• Must be reviewed by physician
• Increase in physical space required
• Cost
• PDA
• Entered by patient uploaded into chart
• Small screen and small size is advantage and
  disadvantage

• Paper Record
• Patient manually completes
• Physician (staff) manually enter or scan
• Flow Sheet
• Electronic Medical Record
• Flow Sheet
• Graphing
• Physician vs Patient Entry

See discussions in The Rheumatologist, March
2007/May 2007
76
Data Collection Examples

• Labs
• Patient reported or derived measures
• Pain
• Patient Global
• Function (MDHAQ)
• RAPID
• Fatigue
• MD Global
• Tender and Swollen Joint Counts
• DAS28

• Demographics
• Age
• Sex
• Employment status
• Diagnoses
• Active and Co-morbid
• Medications
• Active and Past

77
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
• DAS28lt3.2 or DAS lt 2.4
• SDAIlt22
• GASlt7
• RAPIDlt2

78
It Takes Very Little Time to Complete a Patient
Report Based Disease Activity Measure
79
Mean Time to Score
Seconds
Pincus T, et al. Abstract 1764 ACR Washington DC
2006
80

RAPID 3
81
Rheumatoid Arthritis Disease Activity Index RADAI
Self-Report Joint CountFourth Component for
RAPID 4
Stucki G et al. Arthritis Rheum. 199538795-798.

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83
The Short Distance From Where We Are To Where We
Need To Go

• Survey conducted Spring 2007
• 138 Surveys Analyzed

84
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
85
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
86
We are Very CloseFrequently 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
87
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

88
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
  patients ACR score?

89
Benefits of Using Patient Reported Measures

• Patient does most of work-MD time minimal
• Focuses visit
• Saves time
• Avoids wandering discussion
• Reminds patient of variables they may not
  remember
• Objective documentation of patient status in
  patients own hand

• Numerical surrogate for response to management
• 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

90
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

91
Answers to Objections

• Takes too much time
• 
  
• Staff will not cooperate
• Patient will not cooperate
• 
  
• No experience never tried
• Dont 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

92
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!

93
Examples of Forms
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96
Symptom Checklist From MDHAQ Please check (v)
if you have experienced any of the following over
the last month

• __Fever
• Weight gain (gt10 lb)
• Weight loss (lt10 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

__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
97
Recent Medical History Self-report

• Over the last 6 months have you had please check
  (v)
• ?No ?Yes An operation
• ?No ?Yes Inpatient hospitalization
• ?No ?Yes A new illness, accident or trauma
• ?No ?Yes An important new symptom
• ?No ?Yes Side effect(s) of any drug
• ?No ?Yes Cigarettes regularly
• ?No ?Yes Change(s) of arthritis drugs or other
  drugs
• ?No ?Yes Change of address
• ?No ?Yes Change of marital status
• ?No ?Yes Change of job or work duties, quit
  work, retired
• ?No ?Yes Change of medical insurance,
  Medicare, etc.
• ?No ?Yes Change of primary care or other
  doctor
• Please explain any yes" answer below, or
  indicate any
• other health matter that affects you
• __________________________________________________
  _________

98
HAQ, Pt Global, ROS, Meds, MD Global
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