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Abstract Number: 2911

Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health Short Form Is Responsive to Patient Reported Changes in SLE Health Status

Shanthini Kasturi1, Jackie Szymonifka2, Jessica R. Berman3, Kyriakos A. Kirou3, Alana B. Levine3, Lisa R Sammaritano4 and Lisa A. Mandl4, 1Medicine/Rheumatology, Tufts Medical Center, Boston, MA, 2Hospital for Special Surgery, New York, NY, 3Rheumatology, Hospital for Special Surgery/Weill Cornell Medicine, New York, NY, 4Hospital for Special Surgery/Weill Cornell Medicine, New York, NY

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Outcome measures, patient outcomes and systemic lupus erythematosus (SLE), PRO, PROMIS

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Session Information

Date: Wednesday, October 24, 2018

Title: 6W007 ACR Abstract: Patient Outcomes, Preferences, & Attitudes II: PROs (2910–2915)

Session Type: ACR Concurrent Abstract Session

Session Time: 9:00AM-10:30AM

Background/Purpose: The accurate and efficient serial measurement of patient centered outcomes is a priority in the clinical care of SLE. Patient-Reported Outcomes Measurement Information Systems (PROMIS®) Global Health Short Form (PROMIS10) is a 10-item universal patient reported outcome measure of global physical and mental health with construct validity in SLE. The longitudinal responsiveness (sensitivity to change) of PROMIS10 in SLE patients is unknown. We aimed to evaluate the responsiveness of PROMIS10 in SLE outpatients using patient and physician-derived anchors.

Methods: Adults meeting ACR SLE classification criteria were recruited from an SLE Center of Excellence. Subjects completed PROMIS10 at two visits a minimum of one month apart. SLE disease activity was measured with a patient global assessment of change, a physician global assessment and the physician-derived SELENA-SLEDAI. Responsiveness over time of PROMIS10 scores was evaluated using known-groups validity. Effect sizes of changes in PROMIS global physical health and global mental health scores from baseline to follow up were compared across groups of patients who differed in their patient global assessment of change, physician global assessment, and SELENA-SLEDAI using Kruskal-Wallis tests. 

Results: A diverse cohort of 228 SLE patients completed baseline surveys (Table 1), with 190 (83%) completing a follow up survey. Using the patient-based anchor, PROMIS10 demonstrated mild to moderate responsiveness to improvement (effect size 0.29) and worsening (effect sizes -0.27 and -0.54) of health status for both global physical health and global mental health (Table 2). Using the physician global assessment and SELENA-SLEDAI as anchors, there were no statistically significant differences in effect sizes across groups.

Conclusion: PROMIS10 showed responsiveness over time to patient-reported, but not physician-derived changes in lupus health status. These data suggest that PROMIS10 can be used to efficiently measure and monitor important aspects of the patient experience of lupus not captured by physician-derived metrics. Further studies are needed to evaluate the role of PROMIS in optimizing longitudinal disease management in SLE.

Table 1. Baseline Characteristics of Participants (n = 228)

Characteristic

Value

Age, median [IQR] years

37 [29, 49]

Disease duration, median [IQR] years

10.6 [5.8, 16.4]

Sex, n (%)

 

   Male

20 (8.8)

   Female

208 (91.2)

Race, n (%)

 

   White

87 (38.2)

   Black or African-American

64 (28.1)

   Asian

26 (11.4)

   Other

38 (16.7)

   Not Reported

13 (5.7)

Ethnicity, n (%)

 

   Hispanic or Latino

65 (28.5)

   Not Hispanic or Latino

155 (68.0)

   Not Reported

8 (3.5)

Insurance, n (%)

 

   Medicaid

82 (36.0)

   Medicare

22 (9.7)

   Third party/private

124 (54.4)

Physician Global Assessment, median [IQR]

(Possible range 0 – 3)

0.5 [0.3, 1.0]

SELENA-SLEDAI, median [IQR]

(Possible range 0 – 105)

4 [2, 6]

SELENA-SLEDAI Flare, n (%)

32 (17.3)

SLICC-ACR Damage Index, median [IQR]

(Possible range 0 – 46)

1 [0, 2]

Table 2. Responsiveness of PROMIS10: Median Effect Sizes [Number of Contributing Participants] by Anchor Type

Patient Global Rating of Change

Better

Same

Worse

p-value

   Global Physical Health

0.29 [72]

0.0 [76]

-0.27 [31]

<0.01

   Global Mental Health

0.29 [59]

0.0 [72]

-0.54 [25]

<0.01

Physician Global Assessment

Better:

≥ 0.5 point decrease

Same:

< 0.5 point change

Worse:

≥ 0.5 point increase

p-value

   Global Physical Health

0.0 [41]

0.0 [108]

-0.27 [29]

0.22

   Global Mental Health

-0.26 [39]

0.26 [90]

-0.29 [26]

0.23

SELENA-SLEDAI

 

Better:

≥ 3 point decrease

Same:

< 3 point change

Worse:

 ≥ 3 point increase

p-value

   Global Physical Health

0.0 [36]

0.0 [122]

-0.27 [20]

0.19

   Global Mental Health

0.26 [33]

0.0 [105]

-0.31 [17]

0.10

 


Disclosure: S. Kasturi, None; J. Szymonifka, None; J. R. Berman, None; K. A. Kirou, None; A. B. Levine, None; L. R. Sammaritano, None; L. A. Mandl, None.

To cite this abstract in AMA style:

Kasturi S, Szymonifka J, Berman JR, Kirou KA, Levine AB, Sammaritano LR, Mandl LA. Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health Short Form Is Responsive to Patient Reported Changes in SLE Health Status [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/patient-reported-outcomes-measurement-information-system-promis-global-health-short-form-is-responsive-to-patient-reported-changes-in-sle-health-status/. Accessed .
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