Patient Questionnaires Tutorial: Review of MDHAQ and score RAPID3

Patient Questionnaires Tutorial:Review of MDHAQand score RAPID3

Theodore Pincus MDClinical Professor of Medicine

New York [email protected]

Complexities in quantitative assessment of patients with RA and rheumatic diseases

• Laboratory tests are limited in diagnosis and treatment decisions

• Treat radiograph before damage• No single ‘Gold Standard’ measure, eg,

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

• Therefore, need indices of 3–7 measures

Complexities in quantitative assessment of patients with RA and rheumatic diseases

• Patient history and physical examination is more important in clinical management decisions than in diseases with gold standard measure, eg, blood pressure, cholesterol, glucose

• Patient history information may be captured as quantitative "scientific" data using structured patient self-report questionnaires

MDHAQ:Page 1 of 2

1. a - j: Physical

functionk, l, m: Psychological distress

2. Pain

3. RADAISelf-reportjoint count

4. Patient globalestimate

RAPID3

2.7

9.5

9.0

21.2

Visit 1 –Baseline

Visit 1

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

Visit date Visit 1

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

Visit 2 – 2 months after baseline 0

0.5

0.5

1.0

Visit 2

Visit Date 4Nov03 13Jan04

Q-Function (0-10) 2.7 0

Q-Pain (0-10) 9.6 0.3

Q-Global (0-10) 8.9 0.3

RAPID3 (0-30) 21.2 0.6

L-ESR 43 8

T-Prednisone N3qd

T-Methotrexate N10qw

T-Folic Acid N1qd

T-Tylenol w/Codeine 30tid

T-Naproxen 880q6h

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

0

6.0

5.5

11.5

Visit 5 –13 months after baseline

Visit 5


Visit Visit 1 Visit 2 Visit 3 Visit 4 Visit 5

Q-Function (0–10) 2.7 0 0.3 0 0

Q-Pain (0–10) 9.6 0.3 0.2 0.6 6.0

Q-Global (0–10) 8.9 0.3 0.3 1.0 5.5

RAPID3 (0–30) 21.2 0.6 0.8 1.6 11.5

L-ESR 43 8 13 10 14

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

0

0.5

0.5

Visit 6 –15 months after baseline

Visit 6


Visit Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6

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

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

T-Adalimumab N40qow 40qow

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:

MDHAQ Scores

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

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

ou

nt

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- 1985 and Cohort #4-2000: 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

s, %

of

ma

x

RF+

RF-

1985 2000

Patients seen for standard rheumatoid arthritis care have significantly better articular, radiographic,

laboratory, and functional status in 2000 than in 1985

Measure 1985 n=125 2000 n=150 p

Swollen joints(0-28) 12 (6,16) 5 (2,10) <0.001

X-Ray (Larsen - 0-100) 20 (2,36) 3 (0,13) <0.001

ESR 33 (16 , 50) 20 (9,33) 0.016

Hemoglobin (g/L) 129(116,138) 136 (128,143) 0.002

MHAQ Function (0-3) 1.0 (0.6 , 1.4) 0.4 (0.1 , 1.0) <0.001


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

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

Indices to assess patients with RA

ACR DAS28 CDAI RAPID3

# 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 √ -- -- 0-10

Patient global √ 0.014 PTGL 0-10 0-10

TOTAL 0-10 0-76 0-30

RAPID3 versus DAS28 in 285 RA patients

Spearman correlation

rho = 0.657

RAPID=Routine Assessment Patient Index Data; DAS=Disease Activity Score.

Pincus, Swearingen, Bergman, Yazici. RAPID3 J Rheumatol. 35:2136-2147, 2008

RAPID3 versus CDAI in 285 RA patients

Spearman correlation

rho = 0.738

RAPID=Routine Assessment Patient Index Data; CDAI=Clinical Disease Activity Index.

Pincus, Swearingen, Bergman, Yazici. RAPID3 J Rheumatol. 35:2136-2147, 2008

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 et al 2009; Arthritis Care Res. in press

Median Levels of all patients at initiation of Mtx 1996-2001 and mean of 2.6-years later in:

1. 30 incomplete responders initiating biologic agent 2. 63 “control” adequate responders continuing MTX

30 Incomplete Responders

63 Adequate Responders (“Controls”)

MTX StartBiologic

StartMTX Start

Follow-up (NO Biologic)

ESR 28 18 24 16

MDHAQ-Function 3.2 3.3 2.3 1.0

Pain 5.2 6.8 4.1 1.4

Patient Global 5.5 5.5 4.2 0.9

RAPID3 14.9 16.2 10.6 3.6

% 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%

Changes in scores (0-10) for DAS28 and RAPID3 from baseline () to endpoint ( ) in two abatacept clinical trials

6.82 6.836.08 6.21

3.97

5.36

3.08

4.48

0

2

4

6

8

10

Abatacept Control Abatacept Control

AIM

ATTAIN

6.89 6.88 6.60 6.59

4.90

6.17

4.16

5.78

0

2

4

6

8

10

Abatacept Control Abatacept Control

DAS28 RAPID3

Pincus T, et al. Rheumatology (Oxford) 47:345-349, 2008

DAS28, CDAI and RAPID3 show similar scores, categories of high,

moderate, low severity and remission, and improvement criteria

responses in clinical trials of:• Leflunomide• Methotrexate• Adalimumab• Abatacept• Infliximab• Certolizumab

DAS28, CDAI and RAPID3 Categories

Activity levelDAS28(0-10)

CDAI(0-76)

RAPID3 (0-30)

High - change therapy or have a good reason not to

> 5.1 > 22 > 12

Moderate - strongly consider change

3.2-5.1 10.1-22 6.1-12

Low - consider change

2.6-3.2 2.9-10 3.1-6

Remission 2.6 2.8 3

RAPID3 compared to DAS28 categories in 285 RA Patients at 3 Sites

DAS28

RAPID3 Scores

12.1–30= High

Severity

6.1–12.0= Moderate Severity

3.1–6.0= Low Severity

0–3.0=Near Remission Total

>5.1 = High Activity 37 (74%) 11 (22%) 1 (2%) 1 (2%) 50 (17%)

3.2–5.1 = Moderate Activity 39 (43%) 27 (30%) 16 (18%) 8 (9%) 90 (32%)

2.6–3.19 = Low Activity 4 (10%) 15 (38%) 10 (25%) 11 (27%) 40 (14%)

0–2.6 = Remission 10 (10%) 18 (17%) 24 (23%) 53 (50%) 105 (37%)

Total 90 (31%) 71 (25%) 51 (18%) 73 (26%) 285

Pincus, Swearingen, Yazici, Bergman, J Rheumatol, 35:2136-2147, 2008

0%

25%

50%

75%

100%

Pati

en

ts in

Each

RA

PID

3 C

ate

gory

(%

)

Baseline 6 mo 12 mo 24 mo 60 mo

(N=60) (N=60) (N=55) (N=56) (N=43)

37%

33%

17%

13%

29%

25%

27%

18%

36%

25%

18%

21%

30%

30%

12%

28%

53%

30%

13%

3%

High severity(>12)

Moderate severity(6.01-12)

Low severity(3.01-6)

Near remission(3)

RAPID3 categories:

Changes in RAPID3 Scores Over 5 Years in RA Patients in Usual Care 1996-2001

Multi-Dimensional

Health Assessment

Questionnaire (MDHAQ) Page 1

HAQ Page 1

1. Dressing2. Arising3. Eating4. Walking

Aids and devicesHelp from an-

other person

HAQ & multidimensional HAQ (MDHAQ)

HAQ MDHAQ1st report 1980 1999Patient completion 5-10 min 5-10 min

# ADL 20 10Psych, sleep No Sleep, anxiety

depression Pain VAS 10 cm line 21 circlesPt Global VAS 10 cm line 21 circles Scoring templates No YesIndex No RAPID3 RADAI self-report joint count No YesMD Global No Optional

HAQ Page 2

5. Hygiene6. Reach7. Grip8. Activities

Aids and devicesHelp from an-

other person

MDHAQ: Page 2

5. Review of systems

6. Morning stiffness 7. Change in status 8. Exercise 9. Fatigue10. Recent medical

history

Demographic data

MD review

HAQ & multidimensional HAQ (MDHAQ)HAQ MDHAQ

Review of Systems No 60 SymptomsMorning stiffness No YesChange in status No YesExercise No YesFatigue No VAS

Medical history No Surgery, side effects, falls

Demographic data No YesSocial history No Yes

MD “eyeball” 15 secs 5 secsTime to score 42 secs 10 secs

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 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 POORLY

VERY ______________________________________________ VERYWELL POORLY

Symptom Checklist From MDHAQ

Please check (√) if you have experienced any of the following over the last month:

__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

__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

Recent Medical History: Self-reportOver 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:___________________________________________________________

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)

a) Functional capacity (HAQ ≥1 vs. <1)

Mortality in Elderly Normal Finnish population (n=1523) over 5 years by non-biomedical vital signs:

b) Pain (>40 vs. ≤40)

c) Frequency of physical exercise

Cu

mu

lati

ve

Su

rviv

al

Time (years)

HAQ▬▬ < 1▬▬ ≥ 1

Time (years)

Pain▬▬ ≤ 40▬▬ > 40

Time (years)

Exercise▬▬ ≥ 1▬▬ < 1▬▬ none

Keep

ItSimple

Stupid

Pincus and Sokka,

J Rheumatol, 2009

Complexities in assessment of patients with RA and rheumatic diseases

• A person with hypertension, hyperlipidemia, osteoporosis, diabetes, goes to the doctor to have a test to find out how she/he is doing.

• A quantitative measure, e.g., blood pressure, lipid level, bone density, HgA1c supports clinical decisions.

• No lab test is definitive in all patients with rheumatoid arthritis, and the patient tells the doctor about how she/he is doing.

• Should a doctor make a clinical decision on medications without recording a quantitative score for the patient’s function and pain?

Documents

Patient Questionnaires Tutorial: Review of MDHAQ and score RAPID3