M E E N A K S H I J O L L Y , M D , M S

P R O F E S S O R O F M E D I C I N E A N D B E H A V I O R A L S C I E N C E S

D I R E C T O R , R U S H L U P U S C L I N I C

R U S H U N I V E R S I T Y M E D I C A L C E N T E R

Lupus PRO & Lupus Impact Tracker

Disclosures

Intellectual Properties of Rush University Medical Center:

• LupusPRO

• Lupus Impact Tracker (LIT)

• Body Image in Lupus Scale (BILS)

• Simple Disease Assessment for People with Lupus Erythematosus (SIMPLE)

Facts

PRO is a core outcome for SLE.

PRO are not routinely included in care or clinical trials in SLE

SLE Patient report areas of unmet needs

SLE Patient report minimizing symptoms to physicians

Most physicians unaware of SLE patients minimizing symptoms

SLE Patients report difficulty communicating their disease related issues to physicians

Limited Physician time, Complex multi-systemic disease, sensitive issues vs physician-patient discomfort

Smolen. Journal of Rheumatology. 26(2):504-7, 1999

Strand V. Lupus. 9(5):322-7, 2000;

Bertisias. ARD. 2009;68:477-483

GFK Roper Study. National Burden of Disease Survey. 2011

SLE specific PRO tools SLEQOL-2005

LupusQoL -36 items-UK: 2007

LQOL-2009

Leong KP et al. Rheumatology.2005;44(10):1267–76

McElhone K et al. Arthritis Rheum. 2007;57(6):972–9

Doward LC et al. Ann Rheum Dis.2009;68(2):196–200.

Yazdany J. Arthritis Rheum.2011;63: S 413-419

Validated LupusQOL-US

Jolly M et al. Ann Rheum Dis. 2010 ;69(1):29-33

Jolly M et al. J Rheumatol. 2010;37(9):1828-33.

Not fully representative of SLE patients from

USA (ethnic diversity and phenotype, health care systems, women, Non HRQOL)

LupusPRO-v1.7: 43 items :2012

Lupus Impact Tracker-LIT: 10 items: 2014

Jolly M, et al. Semin Arthritis Rheum. 2012; 42(1):56-6 (v1.7)

Jolly M et al. Arthritis Care & Research. 2014 Oct;66(10):1542-50.

Jolly M, et al. Semin Arthritis Rheum. 2012; 42(1):56-6

• Disease-targeted PRO tool

• HRQoL and non-HRQoL constructs

• Derived from Male and Female patients

• Varied Ethnicity

• Gender Neutral language

• 43 items (30+13), 5-7 min to complete

• Higher score = better health

•FDA guidelines

•PROMISE item banks were

consulted

•Items reduced using:

•Psychometric and

Clinimetric methods

•Rasch analysis and Factor

analysis

Iterative Process

Conceptual Model of LupusPRO

Desires/goals

Coping

Social support

Satisfaction with care

Lupus symptoms

Lupus medication

Physical health

Emotional health

Pain

Vitality

Procreation

Cognition Body image

HRQoL

N-HRQoL

Jolly M, et al. Semin Arthritis Rheum. 2012; 42(1):56-6

30 items

13 items

Sleep

Jolly M, et al. Semin Arthritis Rheum. 2012; 42(1):56-6

Jolly M, et al. Semin Arthritis Rheum. 2012; 42(1):56-6

658 visit data were available for 185 patients (2-5 months between consecutive visits) from the Rush Lupus

Clinic Data Repository from 2009-2013

o PGA: significant change for 274 visit data (132 increased, 142 decreased)

o SLEDAI: significant change for 73 visit data (32 increased, 41 decreased)

o SFI: significant change for151 visit data (79 remitting, 72 flaring)

Giangreco D et al. Ann Rheum Dis 2014;73:Suppl 2 335

Giangreco D et al. Ann Rheum Dis 2014;73:Suppl 2 335

Both Directions

Table 1: Responsiveness of LupusPRO to Change in Health

Anchor Used →SF36-Q2

Category N Mean Change P value N Mean Change P value N Mean Change P value N Mean Change P value N Mean Change P value

LupusPRO HRQOL Worse 118 -3.64 <0.001 117 -3.74 <0.001 72 -3.21 0.008 49 -2.72 0.020 21 -7.66 0.001

Same 155 0.17 155 0.25 251 -0.12 341 -0.13 405 0.31

Better 158 2.36 158 2.36 105 2.03 40 3.8

Lupus Symptoms Worse 117 -2.85 0.014 117 -2.71 0.015 72 -8.22 <0.001 49 -5.78 0.005 21 -5.56 0.141

Same 155 -1.02 155 -1.13 251 0.76 341 0.10 405 0.27

Better 158 3.11 158 3.11 105 3.77 41 6.25

Cognition Worse 118 -4.45 0.101 117 -4.77 0.07 72 -2.43 0.803 49 -1.79 0.555 21 -5.36 0.323

Same 155 -0.56 155 -0.32 251 -0.55 341 -0.55 405 -0.65

Better 158 1.03 158 1.03 105 -0.95 41 -4.27

Procreation Worse 118 -2.75 0.08 117 -2.75 0.08 72 -2.43 0.325 49 -1.53 0.566 21 -4.17 0.214

Same 155 0.40 155 0.4 251 0.15 341 0.26 405 0.09

Better 158 1.27 158 1.27 105 0.95 41 -1.83

Physical Health Worse 118 -5.85 <0.001 117 -6.10 <0.001 72 -4.65 0.048 49 -4.80 <0.001 21 -5.95 0.158

Same 155 -0.58 155 -0.39 251 -0.54 341 -1.19 405 -0.39

Better 158 3.23 158 3.23 105 1.95 41 9.02

Lupus Medications Worse 118 -2.44 0.165 117 -2.44 0.165 72 0.69 0.535 49 1.02 0.658 21 -9.52 0.032

Same 155 2.34 155 2.34 251 1.64 341 1.32 405 1.39

Better 158 2.14 158 2.14 105 -1.31 41 -21.13

Pain-Vitality Worse 118 -6.36 0.001 117 -6.36 0.001 72 -3.75 0.008 49 -6.22 <0.001 21 -14.05 0.002

Same 155 -0.84 155 -0.84 251 -2.41 341 -1.58 405 -0.39

Better 158 2.78 158 2.78 105 4.00 41 9.88

Emotional Health Worse 118 -0.81 0.156 117 -1.20 0.147 72 -1.74 0.177 49 -2.47 0.028 21 -10.52 0.006

Same 155 -0.67 155 -0.38 251 -0.15 341 0.21 405 1.17

Better 158 2.98 158 2.98 105 3.21 41 7.83

Body Image Worse 118 -4.41 0.002 117 -4.41 0.002 72 -3.19 0.06 49 -0.20 0.819 21 -6.19 0.088

Same 155 2.29 155 2.29 251 0.12 341 0.38 405 0.71

Better 158 2.34 158 2.34 105 3.29 41 2.07

LupusPRO non HRQOL Worse 118 -1.63 0.137 117 -1.38 0.139 72 0.34 0.575 49 -0.79 0.930 21 -1.96 0.609

Same 155 -1.29 155 -1.48 251 0.16 341 -0.15 405 -0.16

Better 158 1.67 158 1.67 105 -1.66 41 -0.91

Desires-Goals Worse 118 -2.81 0.144 117 -3.18 0.144 72 -4.08 0.308 49 0.64 0.861 21 -8.63 0.155

Same 155 -3.15 155 -2.86 251 0.40 341 -1.45 405 -0.69

Better 158 1.90 158 1.9 105 -2.68 41 -1.37

Social Support Worse 118 -3.50 0.661 117 -2.86 0.736 72 3.13 0.10 49 0.26 0.408 21 -1.63 0.668

Same 155 -1.69 155 -2.18 251 -0.85 341 -1.25 405 1.19

Better 158 -0.24 158 -0.24 105 -6.19 41 -7.32

Coping Worse 118 -1.13 0.429 117 -0.92 0.475 72 0.58 0.271 49 -4.42 0.189 21 -1.59 0.590

Same 155 1.34 155 1.18 251 2.42 341 2.05 405 1.27

Better 158 2.58 158 2.58 105 -1.98 41 0.00

Satisfaction with Treatment Worse 118 0.9 0.449 117 1.43 0.359 72 1.74 0.237 49 0.38 0.547 21 1.00 0.905

Same 155 -1.65 155 -2.06 251 -1.34 341 0.04 405 0.42

Better 158 2.45 158 2.45 105 4.23 41 5.03

Patient reported Change Physician Assessed Change

Global Change in Health PGA SELENA-SLEDAI SDI

Hong Kong Longitudinal Data, n=430 Both Directions

Measurement Equivalence Scale Abbreviated Item US English Spanish Can. English Can. French Philippines English Turkish

N=180 N=195 N=123 N=99 N=100 N=102

Symptoms

Loss of hair 0.75 0.61 0.67 0.56 0.36 0.74

New flare 0.71 0.53 0.68 0.53 0.61 0.43

Lupus flare 0.82 0.99 0.75 0.94 0.87 0.84

Cognition

Poor memory 0.91 0.91 0.97 0.76 0.67 0.97

Lack of concentration 0.96 0.98 0.92 0.66 0.95 0.86

Medication

Bothersome side effects 0.76 0.84 0.81 0.86 0.74 0.74

Concerned with # of meds 0.97 0.81 0.81 0.91 0.92 0.94

Procreation

Meds affect ability to have a baby 0.75 0.62 0.85 0.93 0.92 1.03

Prevent unplanned pregnancy 1.18 1.06 0.82 0.89 0.83 0.74

Physical Health

Take care personal needs 0.85 0.84 0.78 0.83 0.86 0.89

Get in and out of bed/chair 0.9 0.86 0.77 0.87 0.91 0.85

Fulfilling family responsibilities 0.97 0.97 0.86 0.92 0.97 0.98

Taking care of dependents 0.9 0.91 0.84 0.88 0.9 0.95

Burden to family and others 0.96 0.89 0.86 0.89 0.83 0.95

Pain/Vitality

Woke up feeling worn out 0.87 0.83 0.73 0.66 0.62 0.76

Felt pain and aching 0.9 0.9 0.81 0.82 0.69 0.83

Unable to do usual activities due to pain 0.96 0.93 0.86 0.94 0.91 0.92

Performing usual activites for long time 0.97 0.93 0.95 0.93 0.94 0.97

Limited in kinds of activities 0.95 0.96 0.94 0.95 0.91 0.95

Emotional Health

Worried lupus impact 0.93 0.87 0.89 0.87 0.89 0.83

Worried losing income 0.83 0.8 0.78 0.86 0.69 0.68

Anxious 0.85 0.85 0.89 0.82 0.93 0.92

Depressed 0.89 0.9 0.91 0.83 0.84 0.95

Lupus lead to more health problems 0.89 0.82 0.93 0.85 0.8 0.92

Lupus related health problems will last 0.93 0.93 0.96 0.94 0.78 0.96

Scale Abbreviated Item US English Spanish Can. English Can. French Philippines English Turkish

N=180 N=195 N=123 N=99 N=100 N=102

Body Image

Dislike my appearance 0.97 0.87 0.9 0.93 0.86 0.89

Thought less of self 0.97 0.94 0.91 0.92 0.84 0.92

Lack control over

appearance 0.94 0.9 0.91 0.97 0.91 0.85

Conscious about appearance 0.97 0.97 0.95 0.93 0.71 0.82

Embarrassed 0.97 0.96 0.91 0.91 0.85 0.9

Desire-Goals

Ability to plan 0.91 0.86 0.91 0.88 0.80 0.96

Overall life satisfaction 0.91 0.87 0.94 0.91 0.94 0.87

Enjoyment of life 0.91 0.89 0.91 0.96 0.96 0.89

Fulfillment of career goals 0.77 0.85 0.75 0.79 0.77 0.79

Social Support

Received support from

friends 0.98 0.88 0.85 0.96 0.58 0.69

Received support from family 0.92 0.91 0.96 0.92 1.2 1.13

Coping

Focus on making situation

better 0.84 0.78 0.65 0.61 0.71 0.88

Learned to live with lupus 0.81 0.79 0.93 0.91 0.93 0.86

Receive comfort/strength

from spiritual 0.53 0.72 0.52 0.75 0.82 0.89

Satisfaction with Care

Doctor accessible 0.91 0.9 0.85 0.95 0.87 0.8

Doctor understood 0.96 0.91 0.91 0.91 0.94 0.96

Doctor provided information 0.98 0.94 0.99 0.9 0.94 0.94

Doctor monitored side effect 0.97 0.86 0.91 0.87 0.86 0.85

FIT Statistics

CFI 0.98 0.97 0.98 0.97 0.94 0.97

TLI 0.99 0.99 0.99 0.98 0.95 0.98

Jolly M et al. Arthritis & Rheumatism, 2012, 64 (10s): S607.

Measurement Equivalence

The model fit for the hypothesized item to scale relationships was satisfactory (CFI=0.94-0.98, TLI=0.95-0.99).

Item to factor loadings representing the hypothesized item to scale relationships were also satisfactory.

In general, items loaded >0.6 with their respective factor.

Of the 6/43 items showed DIF: (1) woke up feeling worn out, (2) worried about losing income, (3) lacked control over appearance,

(4) ability to plan activities and schedule events, (5) received comfort/strength from

spiritual/religious beliefs, and (6) Doctor was accessible when I had questions.

Considering that 43 item/scale relationships were tested, this was a

small percentage (~13%).

Jolly M et al. Arthritis & Rheumatism, 2012, 64 (10s): S607.

•LUPUSPRO

•V 1.7 validations completed: – English (USA, Canada, Australia, Philippines) – Spanish (USA, Argentina, Mexico) – French (Canada, France) – Tagalog (Philippines) – Turkish (Turkey) – Italian (Italy) – Chinese (Hong Kong*)

•Measurement Equivalence •Ongoing validations: Polish, Portuguese, Hindi, Chinese, Korean, Japan. Enquiries about Arabic.

•Electronic v 1.7 validation Italian done •Responsive to patient reported change, PGA, SLEDAI, SFI, LFA Flare, BILAG •Being used in Lupus Repositories at several centers • Entering Clinical Trials: NIH, BI for LN •V 1.8, validation at ACR 2015/2016

LIT: Needs

Short tool

Feasible-Acceptable-Useful

Physician-Patients

Uni dimensional

Easy to score

Easy to understand

PRO to assess impact of lupus on daily Life/QOL

To help Patient-Physician Communication

LIT development

Jolly M et al. Arthritis Care & Research. 2014 Oct;66(10):1542-50

Lupus Symptoms and Non HRQOL domains except Desires-Goals excluded to match intent of tool

Item Selection Psychometric approach

• Analyses were conducted to identify the subset of items from LupusPRO that would fit a uni-

dimensional structure.

• 21 items

Clinically-oriented approach

• Analyses were conducted to select items from LupusPRO that showed the strongest relationship to

clinical criterion measures.

• 12 items

Qualitative approach:

• Four focus groups were conducted (N=26). SLE patients were shown the LupusPRO and asked to

identify the “top 15” most important items and to rate each item using a 4-point importance scale:

• “How important is this item to a questionnaire assessing the effect of lupus on your health and

quality of life?”

• 0 = not at all important to ask, 1 = slightly important to ask, 2 = moderately important to ask, 3 =

very important to ask.

• Any item that was missing

• 15 items

Item Item Content Psycho-metric Clinically-Oriented Focus Group Top 15

Lupus0 Hair loss X

Lupus1 New flare/skin rash X X

Lupus2 Lupus flare X X

Lupus3 Poor memory X XXX

Lupus4 Lack of concentration X X X

Lupus5 Medication side effect XX X

Lupus7 Number of medication X

Lupus9 Ability to have a baby

Lupus11 Prevent unplanned pregnancy XX

Lupus13 Take care of personal needs XXX

Lupus14 Getting in and out of bed/chair X

Lupus15 Fulfilling family responsibilities X X X

Lupus16 Take care of those who depend on me X X

Lupus18 Burden to family or friends X

Lupus20 Woke up feeling worn out X XX X

Lupus21 Felt pain and aching in body X XXX X

Lupus22 Limited usual activities due to pain X X X

Lupus23 Activities for long period of time X X

Lupus24 Limited activities due to pain/fatigue X X

Lupus25 Impact on my future X X X

Lupus26 Losing income

Lupus28 Anxious X X

Lupus29 Depressed X X

Lupus30 Leads to more health problems X X

Lupus31 Health problems last long time X X X

Lupus32 Dislike my appearance X

Lupus33 Thought less of myself X X

Lupus34 Lack control over my appearance X X

Lupus35 Self conscious about appearance X XX

Lupus36 Embarrassed by how others… X

Lupus37 Health rating X

Lupus38 Ability to plan activities X X

Lupus39 Overall life satisfaction

Lupus40 Enjoyment of life X

Lupus41 Fulfill career goals XX

Cross-Sectional

Dataset

Longitudinal

Dataset

N=250 N=305

SF-36 Scales

Physical functioning -0.58** --

Role functioning -0.63** --

Bodily pain -0.69** --

General health -0.58** --

Vitality -0.74** --

Social role functioning -0.71** --

Emotional role functioning -0.60** --

Mental health -0.68** --

Physical Component Score (PCS) -0.63** --

Mental Component Score (MCS) -0.70** --

Disease Activity

SLEDAI Total 0.26* 0.22*

SLEDAI PGA 0.31** 0.24*

Patient’s Overall Health Rating -0.54** -0.59**

**p<0.001; * p<0.01

Convergent validity

Jolly M et al. Arthritis Care & Research. 2014 Oct;66(10):1542-50

Jolly M et al. Arthritis Care & Research. 2014 Oct;66(10):1542-50

Validated within US and Canada in a prospective study 18 centers

325 SLE patients.

• LIT demonstrated good reliability

Cronbach’s α

Internal Consistency Reliability

Baseline 0.91

3 Month Follow-up 0.92

Test-Retest Reliability 0.88

Garris C et al. Arthritis Rheumatol. 2016 Jun;68(6):1422-31

Discriminant Validity

• LIT significantly distinguishes between categories of disease activity measures

SLEDAI No Activity (0) Mildly Active (1-5) Moderately Active

(6-10) Highly Active

(>10)

N Mean SD N Mean SD N Mean SD N Mean SD F statistic,

p-value

Month 3 64 34.9 23.5 140 31.5 21.7 74 41.9 23.7 17 48.4 27.2 5.3, p=0.002

PGA None (0) Mild (1) Moderate/Severe (2-3)

N Mean SD N Mean SD N Mean SD F statistic, p-

value

Baseline 83 31.7 22.1 152 40.8 22.8 89 44.0 22.3 5.8, p=0.0041

Month 3 88 28.5 20.8 143 35.6 22.3 68 46.8 25.4 12.6, p=0.0000

RECENT FLARE within 10 days of visit

No Yes

N Mean SD N Mean SD F statistic, p value

Baseline 277 38.0 23.1 47 47.2 20.0 4.5, p=0.038

Month 3 252 34.3 23.1 48 45.3 23.7 9.2, p=0.003

Garris C et al. Arthritis Rheumatol. 2016 Jun;68(6):1422-31

France

(N=122)

Germany

(N=125)

Italy

(N=128)

Spain

(N=125)

Sweden

(N=69)

All

(N=569)

p-

valu

e*

LIT score

Mean

(SD)

36.1 (22.9) 28.0 (20.3) 33.5 (22.3) 37.8 (23.0) 37.2 (21.4) 34.2 (22.3) 0.004

Median 33.8 22.5 30.0 37.5 40.0 32.5

Min - max 0 - 95 0 - 85 0 - 95 0 - 100 0 - 85 0 - 100

Devilliers H et al. Ann Rheum Dis2015;74(Suppl2): 799

Devilliers H et al. Rheumatology. 2016 (In press)

The Cronbach alpha coefficients (Reliability) were good:

France: 0.92, Germany: 0.88, Italy: 0.90, Spain: 0.91 and Sweden: 0.89

Construct validity against SF36 was good.

LIT items

Total DIF*

(p-value)

R2-

change

1. I woke up feeling worn out ns -

2. I felt pain and aching in my body <0.001 0.03

3. I was unable to perform my usual activities for long

periods of time because of pain and fatigue ns -

4. I was limited in fulfilling family responsibilities

because of my physical health 0.03 0.01

5. My lupus interfered with my ability to plan activities

and schedule events 0.03 0.01

6. I was anxious <0.001 0.04

•7. I was depressed ns -

8. I experienced difficulty concentrating ns -

9. I was self-conscious about my appearance 0.001 0.02

10. My lupus medication(s) caused bothersome side

effects <0.001

0.02

Variability assessment across countries - Differential Item functioning (DIF)

A cultural DIF of negligible magnitude was detected across countries (pseudo-R2 difference of 0.01-0.04).

Of the variation in item responses, 4% or less were due to a ‘country’ effect and 96% or more were due to

the effect of the disease Devilliers H et al. Ann Rheum Dis2015;74(Suppl2): 799

Devilliers H et al. Rheumatology. 2016 (In press)

Responsiveness

• LIT was highly responsive to patient-reported changes in SLE impact

Patient Evaluation of Change*

Lot More bothered

Little More bothered

About the Same

Little Less Bothered

Lot Less Bothered

N Mea

n SD N

Mea

n SD N

Mea

n SD N

Mea

n SD N

Mea

n SD

F statistic, p-value

LIT Score Change

20 8.2 14.2 54 1.9 14.6 135 -2.6 12.0 52 -8.2 13.4 39 -

14.1 13.1

14.7,

p=0.000

* “Compared to 3 months ago, do your lupus symptoms bother you more or less now?”

Garris C et al. Arthritis Rheumatol. 2016 Jun;68(6):1422-31

Both Directions

658 visit observational data available for 182 SLE patients. Rush University

Giangreco D et al. Lupus. 2015 Dec;24(14):1486-91.

Both Directions

Table 4. Longitudinal responsiveness of LIT to change in disease activity (SLAQ), organ damage (SA-BILD), MCS and PCS of SF-12*

Change in measure

1-year change

(Baseline to year 1)

2 year-change

(Baseline to year 2)

Mean (95%CI) P value Mean (95%CI) P value

Disease Activity¥

SLAQ

Better -11.44 (-14.17, -8.72) <.0001 -13.98 (-16.78, -11.18) <.0001

Same -2.11 (-3.62, -0.61) -2.26 (-3.81, -0.71)

Worse 5.61 (2.42, 8.80) 6.10 (2.64, 9.56)

Organ Damage€

BILD

Same -3.62 (-5.18, -2.07) 0.09 -3.09 (-4.94, -1.25) 0.50

Worse

-1.28 (-3.50, 0.94)

-4.03 (-6.01, -2.05)

Mental SF-12£

Better -9.93 (-12.23, -7.63) <.0001 -11.28 (-13.63, -8.94) <.0001

Same -2.24 (-4.01, -0.46) -3.39 (-5.35, -1.44)

Worse 3.82 (1.40, 6.23) 4.38 (1.97, 6.79)

Physical SF-12£

Better -7.28 (-9.90, -4.66) <.0001 -9.03 (-11.61, -6.45) <.0001

Same -2.96 (-4.64, -1.28) -3.70 (-5.48, -1.92)

Worse 2.11 (-0.62, 4.84) 2.56 (-0.33, 5.46)

Brandt JE et al. Arthritis Care Res (Hoboken). 2016 Aug 26. doi: 10.1002/acr.23009.]

Both Directions

The value of 5.0 seems to indicate a clinically important difference in LIT for SRI.

•Devilliers, Hervé et al. Lupus. 2016 Sep 1. pii: 0961203316667494.

Responsiveness of LIT to patient and physician based anchors in SLE.

430 SLE patients from Hong Kong. Mean LIT score at baseline was 27.8

(18.2) Both Directions

Anchor Change N

Mean Change in LIT p-value

SF36-Q2 Worse 118 +4.7 <0.001

No Change 155 0.3

Much Better 157 -2.5

Global Change in Health StatusWorse 118 4.7 <0.001

No Change 155 0.3

Better 157 -2.5

PGA Increase of ≥0.3 72 2.8 0.02

Stable 251 -1.0

Decrease of ≥0.3 104 -2.7

SELENA- SLEDAI Increase of≥ 4 49 3.5 0.005

Stable 340 -0.6

Decrease of ≥4 41 -6.0

SDI Unchanged 405 0.1

Increase of ≥ 1.0 21 8.7

Patient Reported Change

Patient Assessed Change

0.005

LIT Acceptability, Feasibility, Utility

• Most patients and physicians found LIT to be acceptable, of use and feasible to administer in a clinic setting.

LIT Feedback Questionnaire (selected questions)

Agree/ Strongly

Agree N (%)

Neither Agree nor Disagree

N (%)

Disagree/ Strongly Disagree

N (%)

PATIENT

Helped me remember specific ways lupus impacts my life 280 (87%) 36 (11%) 7 (1%)

Improved communication between my physician and me 229 (71%) 63 (20%) 29 (9%)

Scoring LIT was easy 279 (87%) 33 (10%) 10 (3%)

I would like to use this tool again 263 (73%) 78 (24%) 10 (3%)

PHYSICIAN

Helped me remember to ask specific ways lupus impacts pts. life 309 (64%) 100 (31%) 16 (5%)

Improved communication between my patient and me 164 (51%) 136 (42%) 22 (7%)

Was a burden to me during the office visit 26 (8%) 96 (30%) 199 (62%)

I would like to use this tool again 204 (63%) 96 (30%) 24 (7%)

Garris C et al. Arthritis Rheumatol. 2016 Jun;68(6):1422-31

Patients’ perspective (N=569)

Responses (Agree/strongly agree)

1. Helped me to remember specific ways lupus impacts my life 65.9%

2. Helped me to discuss the impact lupus has on my daily life 68.4%

5. Improved communication between my physician and me 54.3%

9. Scoring the LIT was easy 77.2%

Responses (disagree/strongly disagree)

3. Was a burden to me during the office visit 80.3%

4. Is not necessary 60.7%

6. Disrupted my office visit 79.6%

Physicians’ perspective

Responses (Agree/strongly agree)

1. Helped me to remember to ask about specific ways in which lupus impacts his/her life 61.7%)

2. Helped me to discuss, with my patient, the impact lupus has on his/her daily life 62.8%

5. Improved communication between my patient and me 53.3%)

6. Worked well for this particular patient 52.1%

8. I would like to use this tool again, for this particular patient, in future 55.6%

Responses (disagree/strongly disagree)

3. Was a burden to me during the office visit 49.6%

4. Is not necessary 53.2%

Devilliers H et al. Ann Rheum Dis2015;74(Suppl2): 799

Devilliers H et al. Rheumatology. 2016 (In press)

Lupus Impact Tracker

Validations completed: ◦ English (USA, Canada, Australia)

◦ 5 Languages in Europe (under publication)

French

Spanish

Italian

French, German

◦ Measurement Equivalence shown (under publication)

◦ Responsiveness in three different cohorts to patient reported change, disease activity, SRI composite Index

◦ Presenting at ACR 2016, larger data from Hong Kong

Jolly M et al. Arthritis Care & Research. 2014 Oct;66(10):1542-50

Antony A et al. Lupus. 2016 Aug 11. pii: 0961203316664593

Giangreco D et al. Lupus. 2015 Jul 9.

Garris C et al. Arthritis Rheumatol. 2016 Jun;68(6):1422-31

Us in Lupus

TALKSLE

Available to patients

Summary

Only Lupus PRO tools derived from patients, male and female, of varied ethnic groups, using FDA guidelines for PROs

Referred to PROMISE databank items Item reductions made using patient based and Robust Statistical

methods (Rasch analysis, Factor analysis). At 3 different time points focus groups conducted Only Lupus PRO tools that includes Lupus Medications, Lupus

symptom (Flare), Cognition, Procreation, Sleep AND non HRQOL. Only Lupus PRO and LIT tool have evaluated and documented

measurement equivalence Only Lupus PRO and LIT tools to show responsiveness (in both

directions), and against SRI composite measures. Only LIT where patient-physician feasibility and utility of use

studied. LupusPRO and LITtools supported by years of scientific evidence

Summary

Choice of use is based on Intent and Preferences Brevity vs Comprehensive

Clinical care vs Research

Single Score vs Individual Domains

PQRI vs screen, communication, SDM

LIT score can also be calculated from LupusPRO

LupusPRO and LIT being used in several data repositories for years in the US, and being used in clinical trials.

Both ready for patient-physician use as well as for clinical trials.

Thanks

SLE Patients

Mentors

Collaborators

GSK

Brewer Foundation