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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
N=new drug, C=change in dose, T=taper, D/C=discontinue
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
N=new drug, C=change in dose, T=taper, D/C=discontinue
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
Disease Duration (Years)
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
Disease Duration (Years)
20
16
12
8
4
0
Sw
oll
en J
oin
t C
ou
nt
28
Disease Duration (Years)
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
Pincus, Sokka, Kautiainen, Arth Rheum 52:1009, 2005
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
Pincus, Sokka, Kautiainen, Arth Rheum 52:1009, 2005
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?