rehabilitation teaching and research unit, wellington school of medicine and health sciences outcome...

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


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


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


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


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


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


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


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


DC

AR

T s

core

s

50

45

40

35

30

25

20

15

10

5

0



Group variation (IQR) for DCART

0

2

4

6

8

10

12

Round1 IQR Round2 IQR Round3 IQR



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)


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



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


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




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


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


Clin

ical re

cord

keepin

g

25

20

15

10

5

0



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




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 - 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


Rehabili

tation

35

30

25

20

15

10

5

0



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



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)


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)

rehabilitation teaching and research unit, wellington school of medicine and health sciences outcome...

Documents

core outcome domains

possible outcome domains

list of potential domains

group delphi process

outcome measures

outcome studies of psa

group average

arthritis rheumdevelopment