Implementation of Clinical Measures in Patient Care

Disease Activity Measurement in Clinical Practice

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Faculty

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 Limited Value

• Joint counts

Limited if any use for any one of these parameters alone asbasis 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

0%

20%

40%

60%

80%

100%

EULAR GOOD

EULAR REMIS

SION

ACR20

ACR50

ACR70

IntensiveGroup (n=55)

Routine Group(n=56)

Grigor C,et al. Lancet 2004; 364:263-269

Clin

ical

Res

pons

e

Intensive Treatment Resulted in Better Disease Response

P <0.0001, Intensive vs Routine after month 3.Grigor C, et al. Lancet. 2004;364:263-269.

DAS Scores

Intensive group (n=53)

Routine group (n=50)

0

1

2

3

4

6

5

0 3 6 9 12 15 18

Dis

ease

Act

ivity

Sco

re

Month

Intensive Treatment Resulted in Better Radiologic Scores

Grigor C, et al. Lancet. 2004;364:263-269.

Median parameter

Intensivegroup

(n=53)

Routinegroup

(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

BeSt Trial Study Design

Study design: multicenter, randomized, single-blind, intent-to-treat (ITT) analysis

Objective: evaluate clinical and radiologic outcomesafter 1 year

N=508 patients with early RA (<2 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.

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 determinationsof 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*

*Remission indicates DAS < 2.4.De Vries-Bouwstra JK, et al. Ann Rheum Dis; 2004;63(1):58.

80

70

60

50

40

30

20

10

0

% o

f P

atie

nts

Month

0 3 6 9 12

Mono

Step-up

Combo

Anti-TNF

All patients discontinued infliximab at month 9

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 Routine Care DAS-driven Therapy

P-value

HAQ 0.9 0.7 0.7 0.7 0.029

ΔDAS28 -1.9 -2.7 <0.001

ESR 19 (6 to 37) 13 (3 to 28) 0.011

Goekoop-Ruiterman YPM, et al. ACR, Washington DC 2006, #843

• Conclusion: Intensive therapy achieves better outcomes than routine care

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 CareInformal 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 1.69Patient assessment of

response1.88

Drug tolerability 2.04Physician global assessment 2.14Radiographic assessments 2.94ESR or CRP 3.18Functional outcome measures 4.20Disease activity score (DAS) 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%)

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 (>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

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 asto 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

– Inter and intra observer variation

– Not reproducible

– Hard to track

– Imprecise

• My patient is doing well

• My patient isn’t 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

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

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

Limitations of Formal Joint Counts

13%

32%

11%

14%

16%

14%

Never

1–24% of visits

25–49% of visits

50–74% of visits

75–99% of visits

Always

“For patients with RA under your care (not including patients in clinical trials), how often do you perform formal tender and swollen joint counts?”

Question for Rheumatologists

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 requirements- limits 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 DAS28 SDAI CDAI GAS RAPID*

Pt Functio

n

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

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

Van Gestel et al. Arthritis Rheum. 1998;41(10):1845-50.

Current DAS28: Current DASReduction of DAS28:

>1.2 >0.6 and < 1.2 < 0.6

DAS28 < 3.2 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

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 >26 High disease activityactivity

11-26 Moderate 11-26 Moderate diseasedisease

<11 Mild disease<11 Mild disease <3.3 Remission<3.3 Remission

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

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 >26 High disease activityactivity

11-26 Moderate 11-26 Moderate diseasedisease

<11 Mild disease<11 Mild disease <3.3 Remission<3.3 Remission

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

Requires formal joint count and laboratory test

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)

– Eliminates ESR/CRP

Aletaha and Smolen Clin Exp Rheumatol 23:S100, 2005.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 Aletaha and Smolen Clin Exp Rheumatol 23:S100, 2005.Clin Exp Rheumatol 23:S100, 2005.

Clinical Disease Activity Index CDAI

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

Hodgkin DiseaseAnatomic Stage

Years

20

40

60

80

100

0 2 4 6 8

Su

rviv

al (

%)

10

CStage I

Stage IIAll Stages, All Causes

Stage III

Stage IV

20

40

60

80

100

0 20 40 60 80 100Months

8 Years

9–12 Years

>12 Years

B

Su

rviv

al (

%)

DCoronary Artery

Disease # Involved Vessels

Years

1 Artery

2 Arteries

3 ArteriesLCA20

40

60

80

100

0 2 4 6 8 10

Su

rviv

al (

%)

A100

80

60

40

20

0 20 40 60 80 100

>90%

81%–90%

71%–80%

70%

Su

rviv

al (

%)

Months

% Active “With Ease”

Rheumatoid Arthritis – Activities of Daily Living Rheumatoid Arthritis – Formal Education Level

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

MDHAQ: Multi-Dimensional Health Assessment Questionnaire

5 scales rated 0-10:

– ADL

– Psychological status

– Pain

– Fatigue

– Global status

HAQ and Multidimensional HAQ (MDHAQ)

HAQ MDHAQ1st report 1980 1999Patient completion 5–10 min 5–10 min No. ADL 20 10Pain VAS 10 cm line 21 circlesPt Global VAS 10 cm line 21 circles Psych, sleep No Sleep, anxiety,

depressionRADAI self-report joint count No YesFatigue No VASReview of systems No 60 symptomsMedical history No Surgery, side effectsDemographic data No YesSocial history No YesScoring templates No YesIndex No RAPIDMD scan (“eyeball”) 30 secs 5 secsTime to score 40 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. 1991Borg 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. 1986Wolfe and Zwillich. Arthritis Rheum. 1998Pincus 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)

GAS

Patient pain (0–10)

Raw mHAQ (0–24)

TJC (0–28)

Total 0–62

Cush J, et al. ACR, San Diego 2005, #1854

Mark or Circle the Joint Pain That Hurts

What Jack UsesOne-Page Pt Self-Report Form

Global Assessment

Morning Stiffness

Quality of Sleep

Pain

ADL - mHAQ

Courtesy of Jack Cush MD.

Comorbities

Review of Systems

Joint Pain

Work/disability

PCP, Health, Exercise

Global Arthritis Score (GAS): A Quick Practice Tool for RA Assessment

GAS mHAQSJC

GAS - 0.80 0.63

DAS28 0.88 0.59 0.7

7

SDAI 0.93 0.71 0.78

CDAI 0.90 0.62 0.81

-20

-10

0

10

20

30

40

50

60

0.02 2.02 4.02 6.02 8.02

DAS-28

GA

S

GAS Performance (Spearman Rank Correlations) 64 patients; 244 visits

GAS = TJC (0-28) + Pt Pain (0-10 VAS) + raw mHAQ (0-24)

GAS vs. DAS28R =0.88

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

-60%

DAS vs RAPID in AIM Abatacept Trial

-25%

-32%

-21%

-28% -27%-30%

-43%

-61%

-47%

-54% -52%-56%

-70%

-50%

-40%

-30%

-20%

-10%

0%DAS28 RAPID2 RAPID3

RAPID4-MD

RAPID4-JC RAPID5

Mea

n C

han

ge

( %

)

ControlAbatacept

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

0

20

40

60

80

100

120

140

160

DAS28 CDAI RAPID3 RAPID5

ADA

PBO

Pincus, Amara, Segurado, Bergman, Koch et al ACR 2007

RAPID can be calculated from data used to calculate DAS

Resistance to Questionnaires

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

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 87Staff will not cooperate 63Patient will not cooperate 39No experience – never tried 36Don’t know how to interpret results 33Measures do not change enough to be helpful 24Patient results are not valid results 18

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

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

The “Ten Commandments” of Questionnaires

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

Pincus T, et al. Abstract #1764 ACR Washington DC 2006

Mean Time to Score

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 Mild Moderate Severe

a.LEFT FINGERS 0 1 2 3 i.RIGHT FINGERS 0 1 2 3 b.LEFT WRIST 0 1 2 3 j.RIGHT WRIST 0 1 2 3 c.LEFT ELBOW 0 1 2 3 k.RIGHT ELBOW 0 1 2 3 d.LEFT SHOULDER 0 1 2 3 l.RIGHT SHOULDER 0 1 2 3 e.LEFT HIP 0 1 2 3 m.RIGHT HIP 0 1 2 3 f.LEFT KNEE 0 1 2 3 n.RIGHT KNEE 0 1 2 3 g.LEFT ANKLE 0 1 2 3 o.RIGHT ANKLE 0 1 2 3 h.LEFT TOES 0 1 2 3 p.RIGHT TOES 0 1 2 3

q.NECK 0 1 2 3 r.BACK 0 1 2 3

Stucki G et al. Arthritis Rheum. 1995;38:795-798.

FN 0-10

1=0.3 16=5.3 2=0.7 17=5.7 3=1.0 18=6.0 4=1.3 19=6.3 5=1.7 20=6.7 6=2.0 21=7.0 7=2.3 22=7.3 8=2.7 23=7.7 9=3.0 24=8.0 10=3.3 25=8.3 11=3.7 26=8.7 12=4.0 27=9.0 13=4.3 28=9.3 14=4.7 29=9.7 15=5.0 30=10

PN 0-10

PTGL 0-10

RAPID3 0-30

JT CT 0-10

1=0.2 25=5.2 2=0.4 26=5.4 3=0.6 27=5.6 4=0.8 28=5.8 5=1.0 29=6.0 6=1.3 30=6.3 7=1.5 31=6.4 8=1.7 32=6.7 9=1.9 33=6.9 10=2.1 34=7.1 11=2.3 35=7.3 12=2.5 36=7.5 13=2.7 37=7.7 14=2.9 38=7.9 15=3.1 39=8.1 16=3.3 40=8.3 17=3.5 41=8.5 18=3.8 42=8.8 19=4.0 43=9.0 20=4.2 44=9.2 21=4.4 45=9.4 22=4.6 46=9.6 23=4.8 47=9.8 24=5.0 48=10

RAPID4 0-40

MDGL:0-10

RAPID5 0-50

RAPID5 Multidimensional Health Assessment Questionnaire (MDHAQ)

YOUR NAME:______________________________ Date of Birth: _______________ Today’s Date:______________

2. 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 AS BAD AS PAIN IT COULD BE 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 Mild Moderate Severe LEFT FINGERS □0 □1 □2 □3 RIGHT FINGERS □0 □1 □2 □3 LEFT WRIST □0 □1 □2 □3 RIGHT WRIST □0 □1 □2 □3 LEFT ELBOW □0 □1 □2 □3 RIGHT ELBOW □0 □1 □2 □3 LEFT SHOULDER □0 □1 □2 □3 RIGHT SHOULDER □0 □1 □2 □3 LEFT HIP □0 □1 □2 □3 RIGHT HIP □0 □1 □2 □3 LEFT KNEE □0 □1 □2 □3 RIGHT KNEE □0 □1 □2 □3 LEFT ANKLE □0 □1 □2 □3 RIGHT ANKLE □0 □1 □2 □3 LEFT TOES □0 □1 □2 □3 RIGHT TOES □0 □1 □2 □3 NECK □0 □1 □2 □3 BACK □0 □1 □2 □3

4. Considering all the ways in which illness and health conditions may affect you at this time, please indicate below how you are doing:

VERY VERY WELL POORLY

DO NOT WRITE BELOW THIS – FOR DOCTOR’S USE ONLY – MD Global

VERY WELL VERY POORLY

1. Please check () the ONE best answer for your abilities at this time:

OVER THE PAST WEEK, were you able to: Without ANY

difficulty

With SOME

difficulty

With MUCH

difficulty

UNABLE to do

Dress yourself, including tying shoelaces, doing buttons? □ 0 □ 1 □ 2 □ 3

Get in and out of bed? □ 0 □ 1 □ 2 □ 3

Lift a full cup or glass to your mouth? □ 0 □ 1 □ 2 □ 3

Walk outdoors on flat ground? □ 0 □ 1 □ 2 □ 3

Wash and dry your entire body? □ 0 □ 1 □ 2 □ 3

Bend down to pick up clothing from the floor? □ 0 □ 1 □ 2 □ 3

Turn regular faucets on and off? □ 0 □ 1 □ 2 □ 3

Get in and out of a car, bus, train, or airplane? □ 0 □ 1 □ 2 □ 3

Walk two miles? □ 0 □ 1 □ 2 □ 3

Participate in sports and games as you would like? □ 0 □ 1 □ 2 □ 3

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 10

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 10

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 10

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

Survey conducted Spring 2007

138 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

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%

Survey 2007

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 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 patient’s 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

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

FN 0-10

1=0.3 16=5.3 2=0.7 17=5.7 3=1.0 18=6.0 4=1.3 19=6.3 5=1.7 20=6.7 6=2.0 21=7.0 7=2.3 22=7.3 8=2.7 23=7.7 9=3.0 24=8.0 10=3.3 25=8.3 11=3.7 26=8.7 12=4.0 27=9.0 13=4.3 28=9.3 14=4.7 29=9.7 15=5.0 30=10

PN 0-10

PTGL 0-10

RAPID3 0-30

JT CT 0-10

1=0.2 25=5.2 2=0.4 26=5.4 3=0.6 27=5.6 4=0.8 28=5.8 5=1.0 29=6.0 6=1.3 30=6.3 7=1.5 31=6.4 8=1.7 32=6.7 9=1.9 33=6.9 10=2.1 34=7.1 11=2.3 35=7.3 12=2.5 36=7.5 13=2.7 37=7.7 14=2.9 38=7.9 15=3.1 39=8.1 16=3.3 40=8.3 17=3.5 41=8.5 18=3.8 42=8.8 19=4.0 43=9.0 20=4.2 44=9.2 21=4.4 45=9.4 22=4.6 46=9.6 23=4.8 47=9.8 24=5.0 48=10

RAPID4 0-40

MDGL:0-10

RAPID5 0-50

RAPID5 Multidimensional Health Assessment Questionnaire (MDHAQ)

YOUR NAME:______________________________ Date of Birth: _______________ Today’s Date:______________

2. 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 AS BAD AS PAIN IT COULD BE 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 Mild Moderate Severe LEFT FINGERS □0 □1 □2 □3 RIGHT FINGERS □0 □1 □2 □3 LEFT WRIST □0 □1 □2 □3 RIGHT WRIST □0 □1 □2 □3 LEFT ELBOW □0 □1 □2 □3 RIGHT ELBOW □0 □1 □2 □3 LEFT SHOULDER □0 □1 □2 □3 RIGHT SHOULDER □0 □1 □2 □3 LEFT HIP □0 □1 □2 □3 RIGHT HIP □0 □1 □2 □3 LEFT KNEE □0 □1 □2 □3 RIGHT KNEE □0 □1 □2 □3 LEFT ANKLE □0 □1 □2 □3 RIGHT ANKLE □0 □1 □2 □3 LEFT TOES □0 □1 □2 □3 RIGHT TOES □0 □1 □2 □3 NECK □0 □1 □2 □3 BACK □0 □1 □2 □3

4. Considering all the ways in which illness and health conditions may affect you at this time, please indicate below how you are doing:

VERY VERY WELL POORLY

DO NOT WRITE BELOW THIS – FOR DOCTOR’S USE ONLY – MD Global

VERY WELL VERY POORLY

1. Please check () the ONE best answer for your abilities at this time:

OVER THE PAST WEEK, were you able to: Without ANY

difficulty

With SOME

difficulty

With MUCH

difficulty

UNABLE to do

Dress yourself, including tying shoelaces, doing buttons? □ 0 □ 1 □ 2 □ 3

Get in and out of bed? □ 0 □ 1 □ 2 □ 3

Lift a full cup or glass to your mouth? □ 0 □ 1 □ 2 □ 3

Walk outdoors on flat ground? □ 0 □ 1 □ 2 □ 3

Wash and dry your entire body? □ 0 □ 1 □ 2 □ 3

Bend down to pick up clothing from the floor? □ 0 □ 1 □ 2 □ 3

Turn regular faucets on and off? □ 0 □ 1 □ 2 □ 3

Get in and out of a car, bus, train, or airplane? □ 0 □ 1 □ 2 □ 3

Walk two miles? □ 0 □ 1 □ 2 □ 3

Participate in sports and games as you would like? □ 0 □ 1 □ 2 □ 3

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 10

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 10

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 10

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 Change(s) of arthritis drugs or other drugs �No �Yes Inpatient hospitalization �No �Yes Change(s) of address �No �Yes A new illness, accident or trauma �No �Yes Change(s) of marital status �No �Yes An important new symptom �No �Yes Change job or work duties, quit work, retired �No �Yes Side effect(s) of any drug �No �Yes Change of medical insurance, Medicare, etc. �No �Yes Smoke cigarettes regularly �No �Yes 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 Work Status: � Full-time � Part-time � Disabled 11 12 13 14 15 16 17 18 19 20 � 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 Yes An operationNo Yes Inpatient hospitalizationNo Yes A new illness, accident or trauma No Yes An important new symptom No Yes Side effect(s) of any drugNo Yes Cigarettes regularlyNo Yes Change(s) of arthritis drugs or other drugsNo Yes Change of address No Yes Change of marital statusNo Yes Change of job or work duties, quit work, retiredNo Yes Change of medical insurance, Medicare, etc.No Yes Change of primary care or other doctor

Please explain any “yes" answer below, or indicate anyother health matter that affects you:___________________________________________________________

HAQ, Pt Global, ROS, Meds, MD Global