rehabilitation teaching and research unit, wellington school of medicine and health sciences outcome...
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Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Outcome measures in psoriatic arthritis
Preliminary identification of core domains using Delphi methodology
William Taylor FRACP FAFRM for the Psoriatic Arthritis Working Group
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Background
• No agreed core outcome domains or measures for clinical studies of PsA
• Other rheumatic diseases have standard criteria for determining improvement in disease activity or response to therapy
• Initiation of the process alongside CASPAR meeting Oct 2002, aiming for OMERACT 2004
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Objectives
• To arrive at a consensus-based list of core domains that should be used in outcome studies of PsA, including:– Disease controlling anti-rheumatic therapy trials
– Symptom modifying anti-rheumatic therapy trials
– Clinical record keeping and observational studies
– Rehabilitation intervention studies
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Methods - outline
• Review of existing instruments used to assess health status in PsA (Gladman et al, Arthritis Rheum)
• Development of a list of potential domains via email discussion amongst steering committee of Psoriatic Arthritis Working Group
• Delphi process to rank and prioritize these domains amongst members of CASPAR plus others nominated by the steering committee
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Methods – Delphi 1Jones J, Hunter D. Qualitative Research: Consensus methods for medical
and health services research. BMJ 1995;311(7001):376-380.
• The features of consensus methods are anonymity, iteration, controlled feedback, statistical group response
• Useful when evidence on an issue is lacking or contradictory
• Delphi involves some kind of questionnaire to indicate agreement with particular issues, the group average and variation are then fed back on subsequent rounds to permit changes in participants’ opinions
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Methods – Delphi 2
• The questionnaire requested 100 points to be distributed amongst 26 possible outcome domains, under the four measurement contexts
• The point allocation reflects the relative importance of that domain to the measurement context
• Three rounds were held by email or fax
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Results - outline
• 32 from 54 rheumatologists with an interest in PsA responded to the first round
• 32 responded to 2nd round; 29 responded to 3rd round (last observation carried forward)
• Clear reduction in variability over the three rounds, but the relative ranking of domains didn’t alter a great deal
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Group median scores for DCART
0
2
4
6
8
10
12
14
Active
JC
Xray
dam
age
Patien
t glob
alPain
Physic
al fun
ction
Acute
pha
seQOL
Dacty
litis
Enthe
sitis
Damag
ed JC Skin
Physic
ian g
lobal
Mor
ning
stiffn
ess
Spinal
mob
ility
- lum
bar
Utility
inde
xSlee
p
Extra
-ske
letal
Fatigu
e
Sacro
iliac
test
s
Xray
joint
infla
mm
ation
Spinal
mob
ility
- tho
racic
Spinal
mob
ility
- cer
vical
Tend
initis
Obser
ved
phys
ical
Wor
k lim
itatio
ns
Wor
k inc
apac
ity
Round1 Median Round2 Median Round3 Median
DCART – results #1
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
DC
AR
T s
core
s
50
45
40
35
30
25
20
15
10
5
0
DCART – results #2
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Group variation (IQR) for DCART
0
2
4
6
8
10
12
Round1 IQR Round2 IQR Round3 IQR
DCART – results #3
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Conclusion - DCART
• The following domains are ranked highest:– Active joint count, xray damage, patient global,
pain, physical function, acute phase response (score 7-12)
• Several other possible domains– Dactylitis, enthesitis, damaged joint count, skin
disease, physician global, quality of life (score 5)
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
SMARD median values
0
2
4
6
8
10
12
14
16
18
20
Pain
Patie
nt g
lobal
Phys
ical f
unct
ion
Quality
of l
ife
Active
JC
Mornin
g st
iffne
ss
Phys
ician
glob
al
Enth
esitis
Dacty
litis
Fatig
ue
Wor
k inc
apac
ity
Wor
k lim
itatio
ns
Phys
ical p
erfo
rman
ce Skin
Acute
pha
se
Damag
ed JC
Tend
initis
Spinal
mobilit
y - c
ervic
al
Spinal
mobilit
y - t
hora
cic
Spinal
mobilit
y - l
umba
r
Xray
- inf
lammat
ion
Xray
- dam
age
Sacro
iliac
test
s
Extra
-ske
letal
Sleep
Utility
indic
es
Round1 median Round2 Median Round3 Median
SMARD – results #1
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
SMARD – results #2
Utility indices
Sleep
Extra-skeletal
Sacroiliac
Xray damage
Xray inflamm
ation
Spinal lumbar
Spinal thoracic
Spinal cervical
Tendinitis
Damaged JC
Acute phase
SkinObserved function
Work lim
itations
Work incapacity
Fatigue
Dactylitis
Enthesitis
Physician global
Morning stiffness
Active JC
QOLPhysical function
Patient global
Pain
SM
AR
D s
core
s
55
50
45
40
35
30
25
20
15
10
5
0
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
SMARD score variation
0
2
4
6
8
10
12
14
Pain
Patien
t glob
al
Physic
al fun
ction
Quality
of li
fe
Active
JC
Mor
ning
stiffn
ess
Physic
ian g
lobal
Enthe
sitis
Dacty
litis
Fatigu
e
Wor
k inc
apac
ity
Wor
k lim
itatio
ns
Physic
al pe
rform
ance
Skin
Acute
pha
se
Damag
ed JC
Tend
initis
Spinal
mob
ility
- cer
vical
Spinal
mob
ility
- tho
racic
Spinal
mob
ility
- lum
bar
Xray
- inf
lamm
ation
Xray
- da
mag
e
Sacro
iliac
test
s
Extra
-ske
letal
Sleep
Utility
indic
es
Round1 IQR Round2 IQR Round3 IQR
SMARD – results #3
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
SMARD - conclusion
• Highest scored domains (score 10 to 18)– pain, patient global assessment, physical
function, quality of life and active joint count
• Other possible domains (scored 4 to 5)– morning stiffness, physician global assessment,
enthesitis, dactylitis and fatigue
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Clinical record keeping, medians
0
2
4
6
8
10
12
Pain
Patie
nt g
loba
l
Activ
e JC
Xray
join
t dam
age
Physi
cal fu
nctio
n
Quality
of li
fe
Morni
ng s
tiffne
ss
Physi
cian
glob
alSkin
Acut
e ph
ase
Damag
ed JC
Enthe
sitis
Dactyl
itis
Spina
l - lu
mba
r
Tend
initis
Spina
l - ce
rvica
l
Sleep
Wor
k inc
apac
ity
Wor
k lim
itatio
ns
Obser
ved
phys
ical
Spina
l - th
orac
ic
Xray
join
t infla
mm
atio
n
Sacro
iliac
Fatig
ue
Utility
indi
ces
Extra-
skel
etal
Round1 median Round2 median Round3 median
Clinical record keeping – results #2
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Clin
ical re
cord
keepin
g
25
20
15
10
5
0
Clinical record keeping – results #2
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Clinical records - variation (IQR)
0
2
4
6
8
10
12
Pain
Patien
t glob
al
Active
JC
Xray
joint
dam
age
Physic
al fun
ction
Quality
of li
fe
Mor
ning
stiffn
ess
Physic
ian g
lobal
Skin
Acute
pha
se
Damag
ed JC
Enthe
sitis
Dacty
litis
Spinal
- lum
bar
Tend
initis
Spinal
- cer
vical
Sleep
Wor
k inc
apac
ity
Wor
k lim
itatio
ns
Obser
ved
phys
ical
Spinal
- tho
racic
Xray
joint
infla
mm
ation
Sacro
iliac
Fatigu
e
Utility
indic
es
Extra
-ske
letal
Round1 IQR Round2 IQR Round3 IQR
Clinical record keeping – results #3
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Conclusions – clinical record keeping
• Three domains score highly (score 10) – pain, patient global assessment and actively
inflamed joints
• Large number of others (score 4 to 5)– radiological damage, physical function, quality
of life, morning stiffness, physician global assessment, skin disease, acute phase reactant, damaged joint count, enthesitis, dactylitis
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Rehabilitation - group median
0
2
4
6
8
10
12
14
16
Phys
ical f
unct
ion
Quality
of l
ife Pain
Patie
nt g
lobal
Wor
k lim
itatio
ns
Wor
k inc
apac
ity
Phys
ical p
erfo
rman
ce
Active
JC
Spinal
mobilit
y - c
ervic
al
Spinal
mobilit
y - l
umba
r
Phys
ician
glob
al
Spinal
mobilit
y - t
hora
cic
Fatig
ue
Mornin
g st
iffne
ss Skin
Acute
pha
se
Damag
ed JC
Enth
esitis
Dacty
litis
Tend
initis
Xray
- inf
lammat
ion
Xray
- dam
age
Sacro
iliac
test
s
Extra
-ske
letal
Sleep
round1 median round2 median round3 median
Rehabilitation – results #1
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Rehabili
tation
35
30
25
20
15
10
5
0
Rehabilitation – results #2
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Rehabilitation - IQR
0
2
4
6
8
10
12
14
Phys
ical f
unct
ion
Quality
of l
ife Pain
Patie
nt g
lobal
Wor
k lim
itatio
ns
Wor
k inc
apac
ity
Phys
ical p
erfo
rman
ce
Active
JC
Spinal
mobilit
y - c
ervic
al
Spinal
mobilit
y - l
umba
r
Phys
ician
glob
al
Spinal
mobilit
y - t
hora
cic
Fatig
ue
Mornin
g st
iffne
ss Skin
Acute
pha
se
Damag
ed JC
Enth
esitis
Dacty
litis
Tend
initis
Xray
- inf
lammat
ion
Xray
- dam
age
Sacro
iliac
test
s
Extra
-ske
letal
Sleep
round1 IQR round2 IQR round3 IQR
Rehabilitation – results #3
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Conclusion - rehabilitation
• The following domains are ranked highest:– Pain, patient global, physical function, quality
of life, morning stiffness (score 10-15)
• Several other possible domains– Work incapacity, work limitations, observed
physical performance, physician global (score 5-7)
Rehabilitation Teaching and Research Unit, Wellington School of Medicine and Health Sciences
Final conclusion
• List of possible domains for discussion has been significantly shortened
• Now requires involvement of patient groups, broader rheumatology group, and industry
• Next step should probably be face-to-face discussion to refine the core lists (?when)