A proposed 15 second checklist of 10 measures for all usual care rheumatology visits

A proposed 15 second checklist of 10 measures for all usual care rheumatology

visits

Theodore Pincus, MDClinical Professor of Medicine

New York University school of [email protected]

1

What is the most significant risk factor for mortality over 5-20 years in patients

with RA?

2

1 2 3 4 5

0% 0% 0%0%0%

51. Presence of

rheumatoid factor

2. Poor functional status

3. Quantitative radiographic score

4. Presence of ACRA (anti-CCP)

5. Number of swollen joints

What is the number of units in a Sharp/van der Heidje radiographic

score?

3

64128

224448

660

0% 0% 0%0%0%

51. 64

2. 128

3. 224

4. 448

5. 660

Approximately what proportion of new patients with RA have an ESR greater than

28mm/Hr?

4

50%60%

70%80%

90%

0% 0% 0%0%0%

51. 50%

2. 60%

3. 70%

4. 80%

5. 90%

Approximately what proportion of new patients with rheumatoid arthritis have anti-citrullinated peptide

antibodies (ACPA or anti-CCP)?

5

50%60%

70%80%

90%

0% 0% 0%0%0%

51. 50%

2. 60%

3. 70%

4. 80%

5. 90%

What is the primary reason that “revolutionary” new biological therapies for RA lead to only 60% ACR 20 responses?

Non-ta

rgeted d...

Fibro

myalgi

a

Damage to jo

in...

Design of c

lin...

25% 25%25%25%5

1. Non-targeted different cytokines causing inflammation

2. Fibromyalgia

3. Damage to joints

4. Design of clinical trails

A proposed 15 second checklist of 10 measures for all usual care rheumatology

visits

Theodore Pincus, MDClinical Professor of Medicine

New York University school of [email protected]

7

A checklist is a type of informational job aid used to reduce failure by compensating for potential limits of human memory and attention. It helps to ensure consistency and completeness in carrying out a task. A basic example is the "to do list.”

http://en.wikipedia.org/wiki/Failure

http://en.wikipedia.org/wiki/Memory

http://en.wikipedia.org/wiki/Attention

• An airline pilot (and now often a surgeon) must complete a standard checklist before using his/her skills to fly an airplane (or operate).

Surgical Safety Checklist•Has the patient confirmed his/her identity,

site, procedure, and consent?•Is the site marked?•Is the anaesthesia machine and medication

check complete?•Is the pulse oximeter on the patient and

functioning?•Does the patient have a known allergy?•Difficult airway or aspiration risk?•Risk of >500ml blood loss (7ml/kg in children)?

•How many agree with these statements?

•Rheumatologists help their patients as much as any specialist helps any group of patients

•Rheumatology care is underappreciated by the general medical community, public, payers

•A primary explanation may be that rheumatologists generally little data to document improvement quantitatively

• Why shouldn’t a rheumatologist follow a “scientific” procedure similar to pilots and surgeons to use a quantitative checklist at each patient visit before using skills in clinical care?

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 T, et al. Ann Rheum Dis. 2006;65:820-822.

Clinical Decisions SurveyAll clinical encounters for diagnosis and management of different diseases include 5 sources of clinical information:

Clinician-intensive(1) patient history (2) physical examination

Clinician-non-intensive(3) vital signs (4) laboratory tests(5) ancillary data, e.g., imaging

studies, endoscopies, etc.

Clinical Decisions Survey• Please indicate your opinion of the

importance of each of 5 sources to provide 0-20%, 21-40%, 41-60%, 61-80%, or 81-100% of information for diagnosis and management of 8 diseases:

1.hypertension2.diabetes mellitus3.rheumatoid arthritis 4.hypercholesterolemia 5.pulmonary fibrosis6.ulcerative colitis7.lymphoma8.congestive heart failure

Highest ranked source of clinical information 588 MDs:

ElementCongHeartFail-ure

Dia-betes Mell-litus

Hyp-erten-

sion

Hyp-erli-pid-

emia

Lym-pho-ma

Pul-mo-naryFib

Rheu-mat

Arth-ritis

Ulcer-ativeColi-tis

Vital Signs

Patient History

Physical Exam

Lab tests

Other studies

McCollum, Durusu Tanriover, Akalžn , H Yazici, Pincus: EULAR 2010

>50%: 20-50%: <20%:

•Most rheumatologists say that a patient history and doctor’s physical examination are more important than laboratory tests in clinical decisions.

•However, the only quantitative data in the usual medical record are laboratory tests.

•Therefore, only “gestalt” narrative “unscientific” MD opinions are available to try to recognize whether patients are better or worse over long periods.

•Despite clinical advances, most rheumatology patient encounters are conducted very similarly to 40 years ago.

Disease Standard BiomarkerMeasure

Biomarker Measure in clinical

trials

BiomarkerMeasure in

clinical care

Hyper-tension

Blood pressure

Blood pressure

Blood pressure

Diabetes Glucose,

Hgb A1c

Glucose,

Hgb A1c

Glucose,

Hgb A1c

Rheuma-toid

Arthritis

RF, anti-CCP, ESR, CRP

ACR Core Data Set, DAS28

Standard scientific measures in medical care


Disease Standard BiomarkerMeasure

Biomarker Measure in

clinical trials

BiomarkerMeasure in

clinical care

Hyper-tension

Blood pressure

Blood pressure

Blood pressure

Diabetes Glucose,

Hgb A1c

Glucose,

Hgb A1c

Glucose,

Hgb A1c

Rheuma-toid

Arthritis


ACR Core Data Set, DAS28




Why is a checklist needed for optimal assessment of patients

with rheumatic diseases?• No single ‘Gold Standard’ measure, e.g.,

blood pressure, cholesterol, glucose, for diagnosis and management in all individual patients

• Laboratory tests, the primary source of quantitative data in many diseases, are limited in rheumatic diseases

• Indices of 3–7 measures, based on Core Data Set used in formal clinical research

RA Core Data Set – 7 or 8 measuresSource: MD

examX-ray

Lab Patient self-report

Tender joint count √√

Swollen joint count √√

Assessor Global estimate √√

ESR or CRP √√

Phys Function-HAQ,MDHAQ √√

Pain √√

Patient Global estimate √√

Radiographic score if >1 yr √√Felson et al, Arthritis Rheum 36:729, 1993. van Riel, Br J Rheumatol 31:793, 1994.

What should be included in a rheumatology visit checklist?Types of measures in care of patients with rheumatic diseases:

•Laboratory tests•Joint counts•Radiographic scores•Patient questionnaire scores

Laboratory tests for a rheumatology visit checklist?

"the erythrocyte sedimentation rate is increased in nearly all patients with active RA”

Lipsky PE. Rheumatoid arthritis. In: Fauci AS, Langford CA, eds. Harrison's Medicine. New York: McGraw-Hill,2006:85.

“at least 5% of patients with clinically active disease may have a normal ESR”

Chatham WW, Blackburn WD, Jr. Laboratory findings in rheumatoid arthritis. In: Koopman WJ, Moreland LW, editors. Arthritis and allied conditions: a textbook of rheumatology. Philadelphia, PA: Lippincott, Williams & Wilkins, 2005:1207

Textbook statements concerning ESR in RA

Traditional approaches to clinical expertise:

EMINENCE BASED MEDICINE - making the same mistakes with increasing confidence over an impressive number of years

ELOQUENCE BASED MEDICINE - a year-roundsuntan and brilliant oratory may overcome absence of any supporting data

ELEGANCE BASED MEDICINE - where the sartorialsplendor of a silk-suited sycophant substitutes for substance

The modern alternative?

EVIDENCE BASED MEDICINE - the best approach to clinical data - requires information from clinical observational data in addition to clinical trials

Pincus and Tugwell J Rheumatol 2006

ESR Values in Patients With RA Wolfe F, Michaud K, J

Rheumatol. 1994;21:1227–1237. Wichita KS, USA

ESR ≥ 28 mm/h

ESR < 28 mm/h

Females 63% 37%

Males 55% 45%

Similar results have been reported from:Nashville, TN, USA Jyvaskyla, FinlandOslo, Norway Nancy, FranceGroningen, The Netherlands Belfast, Ireland

Location Yr of

reportn

% ESR<28 mm/Hr

Mean Median

ESR (mm/h)

Wichita, KS, USA1 1994 1556 F37%,M45% 37F, 34M

Oslo, Norway2 1996 237 26

Nancy, France2 1996 135 29

Groningen, Netherlands2 1996 283 28

Belfast, N Ireland2 1996 51 28

Jyvaskyla, Finland 3 2009 1892 45% 30

Nashville, TN, USA3 2009 738 47% 30

ESR in 7 Locations 1994-2005

1- Wolfe and Michaud, J Rheumatol. 1994;21:1227–1237.2- Smedstad, Kvein, et al. Br J Rheumatol 1996;35:746-751.3- Sokka T, Kauitinen, Pincus. J Rheumatol. 2009;36(1):1387-1390.

Meta-analysis: Anti-cyclic citrullinated peptide (CCP) antibody and rheumatoid factor (RF)

Anti-CCP RF

Number of studies 37 50

Positive likelihood ratio 12.5 4.9

Odds ratio for RA 16.1 – 39.0 1.2 – 8.7

Nishimura K et al. Annals of Internal Medicine 146:797-808, 2007

Meta-analysis: Anti-cyclic citrullinated peptide (CCP) antibody and rheumatoid factor (RF)

Anti-CCP RF

Number of studies 37 50

Positive likelihood ratio 12.5 4.9

Odds ratio for RA 16.1 – 39.0 1.2 – 8.7

Sensitivity 67% 69%

Specificity 95% 85%

% of patients with negative test result 33% 31%

Nishimura K et al. Annals of Internal Medicine 146:797-808, 2007

% of RA patients with abnormal measures at presentation: Evidence – not eminence –

based• ESR >28 mm/Hr - 57%

• CRP >10 - 58%

• Rheumatoid factor positive - 69%

• Anti-CCP positive - 67%

• Function score >2/10 - 70%

• Pain score >2/10 - 89%

Wolfe F, et al. J Rheumatol. 1994;21:1227-37. Sokka T, et al. J Rheumatol. 2009;36:1387-90.Nishimura K, et al. Ann Intern Med. 2007;146:797-808.Pincus T, Swearingen CJ. [Abstract #432] Arthritis Rheum 2009;60(Suppl):S160

Proposed Laboratory Biomarkers for Rheumatoid

Arthritis Over 60 Years1950s Rheumatoid factor1960s Immune complexes1970s HLA type, Prostaglandins1980s Shared epitope 1990s Monoclonal Abs,Anti-CCP2000s Genes, cytokine targets

•Of course, the laboratory remainsthe primary source of further understanding of pathogenesisand advances in therapy.

•Nonetheless, for clinical care, laboratory tests have substantial limitations, including normal values in 30-50% of individual patients with many diseases, and often do not change decisions about therapy.

Formal quantitative joint count for a rheumatology visit checklist?

A simplified twenty-eight-joint quantitative articular

index in rheumatoid arthritis

HA Fuchs, RH Brooks, LF Callahan, T Pincus

Arthritis Rheum 32:531-537, 1989

Relative efficiencies of 7 ACR Core Data Set measures in 4

adalimumab clinical trials2.72 2.65

2.06

1.66

1.30

0.22

0.94

2.12

1.48 1.43

1.001.001.001.00

1.12

1.421.55

1.10

0.60

1.86

1.27

1.601.52

1.17

1.48

0.92

1.36

2.14

0.00

0.50

1.00

1.50

2.00

2.50

3.00

ARMADA DE011 DE019 STAR

Tender Joint Count

Swollen Joint Count

Assessor Global

CRP

Function (HAQ)

Pain

Patient Global

Relative efficiencies of 7 Core Data Set measures and 3 Indices, DAS28, CDAI, and RAPID3, to distinguish patients treated with

infliximab vs control therapies in ATTRACT and ASPIRE clinical trials

Furer, Pincus, et al, EULAR 2009

Effect Size

Patient questionnaire

–1.5 –1.3 – 1.1 – 0.9 – 0.7 – 0.5 – 0.3 – 0.1 0.1 0.3 0.5

Malalignment

Limited motionJoint space narrowing

TendernessSwelling

Pain on motion

Radiographic

Type of measure:

Joint count

Laboratory

Clinical

Deformity

Erosions

Erythrocyte sedimentation rateRheumatoid factor titer

HemoglobinMorning stiffness

Grip strengthWalk time

Button timeFunctional status–MHAQ

Global statusPain–visual analog scale

Helplessness

Better

Worse

MHAQ=modified Health Assessment Questionnaire.

Callahan, Pincus et al. Arthritis Care Res 1997;10:381–94

Changes in measures in 100 RA patients – 1985-1990 over 5 years - effect size

Some Limitations of Formal Swollen and Tender Joint

Counts • Relative efficiencies to distinguish active from control treatments in clinical trials are similar or lower than global and patient measures

• May improve over 5 years while joint deformity and functional disability may progress

Joint counts in RA• Of course, joint count is the most

specific measure of RA status.• The most specific measure is not

necessarily most informative.• Poorly reproducible by different

observers - must be done by same observer – not GP, infusion, etc.

• Rigorous formal joint count not performed at most visits

A careful joint examination, rather than a formal joint count may be appropriate for a rheumatology visit.

Radiographs and imaging studies for a rheumatology visit checklist?

Radiographs in Diagnosis and Management of Patients With RA

• Excellent quantitative scoring systems - Sharp, van der Heijde, Larsen, Genant

• Erosions are closest to pathognomonic sign in RA

• Reflect cumulative damage of disease

TEMPO Trial: Year 2 Radiograph: Change in Total Sharp Score from

Baseline to Year 2

* p < 0.05, E vs MTX† p < 0.05, Combination vs MTX ‡ p < 0.05, Combination vs E

-1

0

1

2

3

4

5

6

7

8

Ch

ang

e fr

om

bas

elin

e (M

ean

+/-

SE

)

MTX = 206

E = 203

MTX+E = 2133.34

(CI 1.18, 5.50)

1.10* (CI 0.13, 2.07)

-0.56†‡ (CI –1.05, -0.06)

1 1.59 -0.54 0.52 2.8 0.4 3.7 1.3 3 5.70

50

100

150

200

250

300

350

400

450

ERA ETA ERA MTX TEMPOCombi

TEMPO ETA TEMPO MTX IFX Combi IFX MTX PREMIERCombi

PREMIERADA

PREMIERMTX

Yazıcı Y, Yazıcı H, Arthritis Rheum 2006;54(supl)

Change in Total Sharp/van der Heijde radiographic scores (0-448) in TEMPO trial over 2 years

Van der Heijde A&R2006

RR (95% CL)

P Value

Age 1.07 <0.001 1.06 <0.001

RA Cohort #2- Cox Proportional Hazards Model Analyses Including Demographic, Functional, Self-Report, Joint Count, X-ray, Laboratory and Disease

Variables in 206 patients 1985-1990

P Value

Comorbidity 1.63 <0.001 1.40 0.02

MHAQ ADL Score 2.00 0.003 1.76 0.02

Disease duration 1.04 0.02 -- --

Education 0.89 0.007 -- --

ESR 1.01 0.005 -- --

Joint count 1.02 0.10 -- --

Walking time 1.03 0.04 -- --

X-ray

Univariate Stepwise Model

Callahan, Brooks, Pincus, Arthritis Care Res 10:381,1997

1.40 0.17 -- --

RR (95% CL)

0%

25%

50%

75%

100%

Physicalfunction(N=18)

Handradio-graph(N=18)

Jointcount (N=18)

Rheum-atoidfactor(N=29)

ESR(N=19)

Extra-articulardisease(N=18)

Co-morbidities

(N=23)

Socio-economic

status(N=13)

22%

11%

28%

39%

50%

50%

37%

32%

32%

72%

6%

22%

65%

4%

30%

46%

31%

23%

45%

34%

21%

44%

17%

39%

Significant in multivariate analyses Significant in univariate analyses Not Significant

Significance of 8 variables as predictors of mortality in 53 RA cohorts

Sokka T, Abelson B, Pincus T. Clin Exp Rheumatol 26(suppl):S35-61, 2008

Associations of HLA-DR4 with rheumatoid factor and

radiographic severity in rheumatoid arthritis.

NJ Olsen, LF Callahan, RH Brooks, EP Nance, JJ Kaye, P Stastny, T Pincus

Am J Med 84:257-264, 1988

Radiographs ESR, CRP

Shared epitope

Rheumatoid factorJoint deformity

Duration of disease

Functional disabilityPainPatient global

Joint tendernessFatigueAge

Strongly and Weakly Related Measures to Assess RA

Joint swelling

MRI Can Better Identify Early Bone Erosions than X-ray

Methotrexate in RA Care: 1980-2005Jyvaskyla, Finland & Nashville, TN

Sokka and Pincus. Rheumatology (Oxford). 2008:47:1543-1547.

T Pincus, TWJ Huizinga, Y Yazici

J Rheumatol. 34:250-252, 2007

Some Problems With Radiographs in RA

1. Quantitative score tedious to perform

2. Treatment initiated prior to erosions – MRI, ultrasound more sensitive

3. Radiographic damage has poor prognostic value for work disability, death and even joint replacement

4. Treatment prior to erosions

Patient self-report questionnaire scores for a rheumatology visit checklist?

• Patient questionnaire provides quantitative patient history

• Improvement in rheumatology care cannot be documented optimally without quantitative patient self-report data

• Not having these data in most settings is a major stumbling block for rheumatology

Patient self-report questionnaires in usual rheumatology care

Multi-Dimensional

Health Assessment Questionnai

re (MDHAQ) Page 1

MDHAQ/RAPID3:04 Nov 20033 RA Core Data Set scoresFN (0–10) = 2.7 PN (0–10) = 9.5PTGL (0–10) = 9.0

RAPID3 (0–30) = 21.2

Severity:12.1-30 = High6.1-12 = Moderate3.1-6 = Low0-3 = Near remission

2.7

9.5

9.0

21.2

Indices to assess patients with RAACR 1 DAS28 2 CDAI 3 RAPID3 4

# Tender joints √ 0.56 sq rt (TJC28) 0-28 --

# Swollen joints √ 0.28sq rt (SJC28) 0-28 --

MD global √ -- 0-10 --ESR or CRP √ 0.70

ln (ESR) -- --Patient function √ -- -- 0-10Patient pain √ -- -- 0-10Patient global √ 0.014

PTGL 0-10 0-10TOTAL 0-10 0-76 0-301. Felson DT, et al. Arthritis Rheum. 1993;36;729-49. 2. Prevoo MLL, et al. Arthritis Rheum 1995;38:44-8.3. Aletaha D, Smolen J. Clin Exp Rheumatol 2005;23:S100-8.4. Pincus T, et al. J Rheumatol. 2008;35: 2136-47.DAS = Disease Activity Score, CDAI = Clinical Disease Activity Index.

Visit date 4Nov03

Q-Function (0–10) 2.7

Q-Pain (0–10) 9.5

Q-Global (0–10) 9.0

RAPID3 (0–30) 21.2

L-ESR 43

Prednisone N-3qd

T-Methotrexate N10qw

T-Folic acid N1qd

T-Tylenol w/Codeine 30tid

T-Naproxen 880q6h

N=new medication, C=change in dose, T=taper, D/C=discontinue

Visit 1: 14 Nov 2003

RAPID3 versus DAS28 and CDAI in 285 RA patients

Spearman correlation

rho = 0.657Pincus T, et al. J Rheumatol. 2008; 35: 2136-2147.

Spearman correlation

rho = 0.738

DAS28 CDAI

Time to Score RA Measures - Seconds

94

42

106

9.6 4.6

114

0

50

100

150

28 JointCount

HAQ-DI DAS28 CDAI RAPID3(0-10)

RAPID3(0-30)

Pincus, Swearingen, Bergman, Colglazier, Kaell, Kunath, Siegel, Yazici Arthritis Care Res. 2010; 62:181-189. HAQ-DI = Health Assessment Questionnaire-Disability Index

MDHAQ/RAPID3:04 Nov 20033 RA Core Data Set scoresFN (0–10) = 2.7 PN (0–10) = 9.5PTGL (0–10) = 9.0

RAPID3 (0–30) = 21.2


2.7

9.5

9.0

21.2

MDHAQ/RAPID3:13 Jan 20043 RA Core Data Set scoresFN (0–10) = 0 PN (0–10) = 0.5PTGL (0–10) = 0.5

RAPID3 (0–30) = 1.0


0

0.5

0.5

1.0

Visit 2: 13 Jan 2004

N = new drug, C = change in dose, T = taper, D/C = discontinue

Visit date 4Nov03 13Jan04

Q-Function (0–10) 2.7 0

Q-Pain (0–10) 9.5 0.5

Q-Global (0–10) 9.0 0.5

RAPID3 (0–30) 21.2 1.0

Tender Joint Count (0-28) 14 2

Swollen Joint Count (0-28) 12 1

MD Global (0-10) 8.0 1.0

CDAI (0-76) 43.0 4.5

L-ESR 43 8

T-Prednisone N3qd 3qd

T-Methotrexate N10qw C20qw

T-Folic acid N1qd 1qd

T-Tylenol w/Codeine 30tid 30tid

T-Naproxen 880q6h 440bid

T-Adalimumab

Visit 4 - 28 Sep 2004

N = new drug, C = change in dose, T = taper, D/C = discontinue

Visit Date 4Nov03 13Jan04 20Apr04 28Sep04

Q-Function (0–10) 2.7 0 0.3 0

Q-Pain (0–10) 9.6 0.3 0.2 0.6

Q-Global (0–10) 8.9 0.3 0.3 1.0

RAPID3 (0–30) 21.2 0.6 0.8 1.6

L-ESR 43 8 13 10

T-Prednisone N3qd 3qd 3qd 3qd

T-Methotrexate N10qw C20qw 20qw 15qw

T-Folic acid N1qd 1qd 1qd 1qd

T-Tylenol w/Codeine 30tid 30tid D/C

T-Naproxen 880q6h 440bid 440bid 440bid

0

6.0

5.5

11.5

MDHAQ/RAPID3:28 Dec 20043 RA Core Data Set scoresFN (0–10) = 0 PN (0–10) = 6.0PTGL (0–10) = 5.5

RAPID3 (0–30) = 11.5


Visit 5: 28 Dec 2004

N=new drug, C=change in dose, T=taper, D/C=discontinue

Visit date 4Nov03 13Jan04 20Apr04 28Sep04 28Dec04

Q-Function (0–10) 2.7 0 0.3 0 0

Q-Pain (0–10) 9.5 0.5 0.0 0.5 6.0

Q-Global (0–10) 9.0 0.5 0.5 1.0 5.5

RAPID3 (0–30) 21.2 1.0 0.8 1.5 11.5

Tender Joint Count (0-28) 14 2 0 0 10

Swollen Joint Count (0-28) 12 1 0 0 8

MD Global (0-10) 8.0 1.0 0.5 0.5 6.5

CDAI (0-76) 43.0 4.5 1.0 1.5 30.0

L-ESR 43 8 13 10 14

T-Prednisone N3qd 3qd 3qd 3qd 3qd

T-Methotrexate N10qw C20qw 20qw 15qw C25qw

T-Folic acid N1qd 1qd 1qd 1qd 1qd


T-Naproxen 880q6h 440bid 440bid 440bid 440bid

T-Adalimumab N40qow

0

0

0.5

0.5

MDHAQ/RAPID3:8 Feb 20053 RA Core Data Set scoresFN (0–10) = 0 PN (0–10) = 0.0PTGL (0–10) = 0.5

RAPID3 (0–30) = 0.5


Visit 6: 8 Feb 2005Visit date 4No03 13Ja04 20Ap04 28Se04 28De04 8Fe05

Q-Function (0–10) 2.7 0 0.3 0 0 0Q-Pain (0–10) 9.5 0.5 0.0 0.5 6.0 0.0Q-Global (0–10) 9.0 0.5 0.5 1.0 5.5 0.5RAPID3 (0–30) 21.2 1.0 0.8 1.5 11.5 0.5

L-ESR 43 8 13 10 14 14T-Prednisone N3qd 3qd 3qd 3qd 3qd 3qd

T-Methotrexate N10qw C20qw 20qw 15qw C25qw C15qw

T-Folic acid N1qd 1qd 1qd 1qd 1qd 1qd


T-Naproxen 880q6h 440bid 440bid 440bid 440bid D/C

T-Adalimumab N40qow 40qow

N=new drug, C=change in dose, T=taper, D/C=discontinue

20001985

0 5 10 15

Disease Duration (Years)

2.0

1.5

1.0

0.5

0.0

MH

AQ


MH

AQ

2.0

1.5

1.0

0.5

0.020 0 5 10 15 20

Cross-Sectional Data in Patients With RA – Cohort #2 in 1985 and Cohort #4 in 2000:

Pincus, Sokka, Kautiainen, Arthritis Rheum 52:1009, 2005

Multidimensional Health Assessment Questionnaire (MDHAQ) scores

20001985

0 5 10 15


20

16

12

8

4

0

Sw

oll

en J

oin

t C

ou

nt

28


Sw

oll

en J

oin

t C

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28

20 0 5 10 15 20

20

16

12

8

4

0

Cross-Sectional Data in Patients With RA – Cohort #2 in 1985 and Cohort #4 in 2000:

Swollen Joint Count Scores


Cross-Sectional Data in RA Patients –

Cohort #2 in 1985 and Cohort #4 in 2000: Larsen X-Ray score,% of

Maximum

0

5

10

15

20

25

30

0 5 10 15

Disease duration

La

rso

n s

co

re f

or

ha

nd

s, %

of

ma

x

RF+

RF-

0

5

10

15

20

25

30

0 5 10 15

Disease duration

La

rso

n s

co

re f

or

ha

nd

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of

ma

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RF+

RF-

1985 2000


Pincus T, Swearingen CJ. [Abstract #1627] Arthritis Rheum 2009;60(Suppl):S608. Presented at ACR, 2009.

Median Levels of All Patients at Initiation of MTX 1996-2001 and Mean of 2.6 Years Later in:

A. 63 “control” adequate responders continuing MTXB. 30 incomplete responders initiating biologic agent

63 Adequate Responders (“Controls”)

30 Incomplete Responders

MTX StartFollow-up

(NO Biologic) MTX StartBiologic

Start

ESR 24 16 28 18

MDHAQ-Function 2.3 1.0 3.2 3.3

Pain 4.1 1.4 5.2 6.8

Patient Global 4.2 0.9 5.5 5.5

RAPID3 10.6 3.6 14.9 16.2

The HAQ or MDHAQ, not a joint count, lab test or X-ray, is Best Predictor in RA of…

• Functional status (Pincus et al Arthritis Rheum 1984; Wolfe et al J Rheumatol 1991)

• Work disability (Borg et al J Rheumatol 1991; Callahan et al J Clin Epidemiol 1992; Wolfe & Hawley J Rheumatol 1998; Fex et al J Rheumatol 1998; Sokka et al J Rheumatol 1999; Barrett et al Rheumatology 2000)

• Costs (Lubeck et al Arthritis Rheum 1986)

• Joint replacement surgery (Wolfe & Zwillich Arthritis Rheum 1998)

• Death (Pincus et al Arthritis Rheum 1984, Ann Intern Med 1994; Wolfe et al J Rheumatol 1988, Arthritis Rheum 1994; Leigh & Fries J Rheumatol 1991; Callahan et al Arthritis Care Res 1996, 1997; Soderlin et al J Rheumatol 1998; Maiden et al Ann Rheum Dis 1999; Sokka et al Ann Rheum Dis 2004)

9-10 Year Survival According to Quantitative Markers in Three Chronic Diseases

Hodgkin’s Disease -Hodgkin’s Disease -Anatomic StageAnatomic Stage

Years

2020

4040

6060

8080

100100

00 22 44 66 88

Su

rviv

al (

%)

Su

rviv

al (

%)

1010

CC

Stage IStage I

Stage IIStage IIAll Stages, All Stages, All CausesAll Causes

Stage IIIStage IIIStage IVStage IV

(Data from Kaplan, 1972)(Data from Kaplan, 1972)

Formal Education LevelFormal Education Level

2020

4040

6060

8080

100100

00 2020 4040 6060 8080 100100 Months

8 Years8 Years

9–12 Years9–12 Years

>12 Years>12 YearsBB

Su

rviv

al (

%)

Su

rviv

al (

%)

(Data from Pincus et al, 1987)(Data from Pincus et al, 1987)

DD Coronary Artery Disease -Coronary Artery Disease - # of Involved Vessels# of Involved Vessels

Years

1 Artery1 Artery

2 Arteries2 Arteries

3 Arteries3 ArteriesLCALCA2020

4040

6060

8080

100100

00 22 44 66 88 1010

Su

rviv

al (

%)

Su

rviv

al (

%)

(Data from Proudfit et al, 1978)(Data from Proudfit et al, 1978)

Activities of Daily LivingActivities of Daily LivingAA100

80

60

40

20

0 20 40 60 80 100

>90%81–90%

71–80%

70%

Su

rviv

al

(%)

Months

(Data from Pincus et al, 1987)(Data from Pincus et al, 1987)

% Active “With Ease”% Active “With Ease”

Rheumatoid Arthritis -Rheumatoid Arthritis - Rheumatoid Arthritis -Rheumatoid Arthritis -

5-Year Survival in 206 Patients With RA: Cohort #2 –

1985-1990

100100

8080

6060

4040

2020

0000 1212 2424 3636 4848 6060

Su

rviv

al (

%)

Su

rviv

al (

%)

Months After BaselineMonths After Baseline

Rheumatoid FactorRheumatoid Factor

Absent (29)Absent (29)

Present Present (175)(175)

100100

8080

6060

4040

2020

0000 1212 2424 3636 4848 6060

Su

rviv

al (

%)

Su

rviv

al (

%)

Months After BaselineMonths After Baseline

MHAQ ScoreMHAQ Score

0.00 (12)0.00 (12)0.01–0.99 (91)0.01–0.99 (91)1.00–1.99 (86)1.00–1.99 (86)>2.00 (21)>2.00 (21)

Callahan LF et al. Arthritis Care Res 10:381,1997

0%

25%

50%

75%

100%

Physicalfunction(N=18)

Handradio-graph(N=18)

Jointcount (N=18)

Rheum-atoidfactor(N=29)

ESR(N=19)

Extra-articulardisease(N=18)

Co-morbidities

(N=23)

Socio-economic

status(N=13)

22%

11%

28%

39%

50%

50%

37%

32%

32%

72%

6%

22%

65%

4%

30%

46%

31%

23%

45%

34%

21%

44%

17%

39%

Significant in multivariate analyses Significant in univariate analyses Not Significant

Significance of 8 variables as predictors of mortality in 53 RA cohorts

Sokka T, Abelson B, Pincus T. Clin Exp Rheumatol 26(suppl):S35-61, 2008

Prediction of premature mortality according to blood

pressure and cholesterol converted hypertension and hypercholesterolemia from

optional treatments to major public health campaigns.

Patient and physician global estimates for a rheumatology visit checklist?

Relative efficiencies of 7 ACR Core Data Set measures in 4

adalimumab clinical trials2.72 2.65

2.06

1.66

1.30

0.22

0.94

2.12

1.48 1.43

1.001.001.001.00

1.12

1.421.55

1.10

0.60

1.86

1.27

1.601.52

1.17

1.48

0.92

1.36

2.14

0.00

0.50

1.00

1.50

2.00

2.50

3.00

ARMADA DE011 DE019 STAR

Tender Joint Count

Swollen Joint Count

Assessor Global

CRP

Function (HAQ)

Pain

Patient Global

Patient MDHAQ self-report questionnaire measures

1. Function

2. Pain

3. Patient global estimate of status

4. RAPID3 (Routine Assessment of Patient

Index Data)

5. Fatigue

6. Symptoms

A proposed checklist of 10 measures for patients with rheumatic disease at all visits

MDHAQ:Page 1 of 2

1.a - j: Physicalfunctionk, l, m:

Psychological distress

2.Pain3.RADAI

Self-reportjoint count

4. Patient globalestimate

RAPID3

MDHAQ:Page 25. Review of

systems6. Morning

stiffness 7. Change in

status 8. Exercise 9. Fatigue10.Recent

medical history

11.Demogra-phic data

MD review

Review of Symptoms (ROS)

RA(n=174)

OA(n=32)

FM(n=196)

SLE(n=34)

Spondy(n=30)

Gout(n=12)

Function [0-10] 3.2 2.3 3.0 1.9 3.0 1.8

Pain [0-10] 5.4 4.4 6.5 3.7 5.9 5.8

PT Global [0-10] 5.4 4.4 6.1 4.3 5.1 3.8

RAPID3 [0-30] 13.7 10.0 15.4 8.5 13.4 10.2

Fatigue [0-10] 5.7 4.2 7.3 5.4 4.5 4.1

Symptoms [0-60] 14.1 9.4 20.5 16.1 11.4 7.7

Quantitative patient MDHAQ scores in new rheumatology patients by diagnosis

FM = fibromyalgia; Spondy = spondylarthropathy. Shaded: Patient measures: FN>3, PN5, PTGL5, FT5, RAPID3>12, SX>20.

RA(n=174)

OA(n=32)

FM(n=196)

SLE(n=34)

Spondy(n=30)

Gout(n=12)

Age (years) 54.5 65.1 47.0 38.8 43.9 59.3

Disease duration (years) 8.4 6.3 5.9 9.1 11.3 9.1

Formal education (years) 13.0 15.0 13.7 13.6 14.9 13.8

% Female 71.3% 65.6% 88.7% 85.3% 46.7% 16.7%

ESR (mm/h) 29.7 22.2 16.8 28.9 26.5 11.1

CRP (mg/dL) [normal <10] 17.5 3.9 6.1 6.7 11.5 3.6

Quantitative demographic and laboratory datain new rheumatology patients by diagnosis

FM = fibromyalgia; Spondy = spondylarthropathy. Shaded: ESR >20, CRP >10.

Highest ranked source of clinical information 588 MDs:

ElementCongHeartFail-ure

Dia-betes Mell-litus

Hyp-erten-

sion

Hyp-erli-pid-

emia

Lym-pho-ma

Pul-mo-naryFib

Rheu-mat

Arth-ritis

Ulcer-ativeColi-tis

Vital Signs

Patient History

Physical Exam

Lab tests

Other studies

McCollum, Durusu Tanriover, Akalžn , H Yazici, Pincus: EULAR 2010

>50%: 20-50%: <20%:

Patient MDHAQ self-report questionnaire measures

1. Function

2. Pain

3. Patient global estimate of status

4. RAPID3 (Routine Assessment of Patient Index Data)

5. Fatigue

6. Symptoms

Physician global measures

7. Physician global estimate of status (DOC Global)

8. Inflammation

9. Damage

10. Non-inflammatory/non-damage

A proposed checklist of 10 measures for patients with rheumatic disease at all visits

4 Physician global estimates: 1.Overall, 2. Inflammation,

3. Damage, 4. Neither

The expertise of a rheumatologist is to determine whether a patient’s pain, fatigue, distress, etc. results from inflammation, damage or neither. Why not record scores?

• Joint count required for RA diagnosis

• Joint count is most specific RA measure

• Joint count has many limitations• Physician global estimates perform

as well as formal joint counts to distinguish active from control treatment in clinical trials

Quantitative physical examination data in RA

RA(n=174)

OA(n=32)

FM(n=196)

SLE(n=34)

Spondy(n=30)

Gout(n=12)

DOC Global [0-10] 6.3 6.3 6.3 5.0 6.3 5.0

Inflammation [0-10] 7.0 3.3 2.3 3.6 7.7 6.0

Damage [0-10] 5.0 6.0 1.7 2.3 4.3 3.0

Non-inflammatory/non-damage [0-10] 4.0 3.7 9.0 6.3 4.0 2.3

Quantitative physician global estimates in new patients by diagnosis – T Pincus

FM = fibromyalgiaSpondy = spondylarthropathy Shaded: All DOC measures 5

Variable RA OA FM SLE Spondy Gout

Overall Physician Global (0-10) 4.03 3.25 4.36 2.00 3.33 2.23

Inflammation (0-10) 4.53 0.57 0.50 2.23 4.17 2.27

Damage (0-10) 2.40 3.83 0.77 0.37 1.58 0.43

Non-inflammatory, Non-damage (0-10) 1.03 0.83 5.13 0.37 1.17 0.43

Quantitative physician global estimates in new patients by diagnosis – M Bergman

FM = fibromyalgiaSpondy = spondyloarthropathyShaded = highest-scored scale for each diagnostic category

RA(n=174)

OA(n=32)

FM(n=196)

SLE(n=34)

Spondy(n=30)

Gout(n=12)

Patient MDHAQ self-report questionnaire measures for proposed checklist

Function [0-10] 3.2 2.3 3.0 1.9 3.0 1.8Pain [0-10] 5.4 4.4 6.5 3.7 5.9 5.8PT Global [0-10] 5.4 4.4 6.1 4.3 5.1 3.8RAPID3 [0-30] 13.7 10.0 15.4 8.5 13.4 10.2Fatigue [0-10] 5.7 4.2 7.3 5.4 4.5 4.1Symptoms [0-60] 14.1 9.4 20.5 16.1 11.4 7.7Physician global measures for proposed checklist

DOC Global [0-10] 6.3 6.3 6.3 5.0 6.3 5.0Inflammation [0-10] 7.0 3.3 2.3 3.6 7.7 6.0Damage [0-10] 5.0 6.0 1.7 2.3 4.3 3.0Non-inflam/non-damage [0-10] 4.0 3.7 9.0 6.3 4.0 2.3

Quantitative patient MDHAQ scores and physician global estimates in new rheumatology patients by diagnosis

FM = fibromyalgia; Spondy = spondylarthropathy. Shaded: Patient measures: FN>3, PN5, PTGL5, FT5, RAPID3>12, SX>20. All DOC measures 5.

Scientific method in medical care: standardized measurement is

prerequisite

Scientific method in medical care: standardized measurement is

prerequisite

• All rheumatology clinical measures are surrogates for pathogenic mechanisms – whether ESR, joint counts, or self-report questionnaire scores.

• All measures require interpretation by a knowledgeable and caring physician.

Is this the final version of a rheumatology visit

checklist?No, it will be improved by

suggestıons from rheumatologists like you from use in clinical care.

Is it better to have 80% of the information in 100% of patients or 100% of the information in

5% of patients?

T Pincus, F Wolfe

J Rheumatol 32:575-577, 2005

Is care for a patient without a HAQ/MDHAQ/RAPID 3,

analogous to care of a patient with hypertension without a blood pressure, or care of a patient with diabetes without hemoglobin A1C or glucose?

A proposed 15 second checklist of 10 measures for all usual care rheumatology visits

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