Session Information
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: PROMIS CATs are precise measures of quality of life with construct validity in SLE. The longitudinal responsiveness (sensitivity to change) of PROMIS CATs in SLE patients is unknown. We aimed to evaluate the responsiveness of PROMIS CATs in SLE outpatients using patient and physician-derived anchors.
Methods: Adult SLE patients were recruited from an SLE Center of Excellence. Subjects completed 14 selected PROMIS CATs 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 of PROMIS scores was evaluated using known-groups validity. Changes in PROMIS 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 Wilcoxon rank-sum 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, there was a trend towards responsiveness across 11 PROMIS CATs (table 2), with statistically significant changes in T-scores with improvement and worsening of health status in Physical Function (effect size 0.15, 0.01, and -0.14 [p <0.02] with “better”, “same”, and “worse” health status respectively), Pain Interference (0.0, 0.0, 0.25 [p <0.02]), and Anger (-0.37, -0.08, 0.0 [p <0.03]) CATs. Using the physician global assessment and SELENA-SLEDAI as anchors, there was no notable trend or statistically significant change in scores across groups, with the exception of the Applied Cognition-Abilities CAT (0.34, -0.01, 0.0 [p <0.01]) when the SELENA-SLEDAI was used as an anchor.
Conclusion: PROMIS CATs showed modest responsiveness to patient-reported, but generally not physician-derived changes in lupus health status. These data suggest that certain PROMIS CATs are precise and sensitive tools which may be used to 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 [5.7, 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%) |
Table 2. Responsiveness of PROMIS CATs: Changes in PROMIS T-Score (median [IQR]) by Anchor Type
|
Patient Global Rating of Change |
Better (n=77) |
Same (n=79) |
Worse (n=34) |
p-value |
|
Ability to Participate in Social Roles |
1.3 [-3.3, 5.4] |
0.0 [-3.5, 2.0] |
0.0 [-4.6, 1.9] |
0.19 |
|
Anger |
-4.1 [-9.1, 0.0] |
-0.9 [-6.1, 5.6] |
0.0 [-7.1, 8.4] |
0.03 |
|
Anxiety |
-3.5 [-7.7, 1.4] |
-0.4 [-4.3, 3.4] |
-0.2 [-6.1, 6.7] |
0.13 |
|
Applied Cognition-Abilities |
1.4 [-2.8, 4.4] |
0.0 [-4.4, 3.5] |
-0.3 [-5.3, 3.6] |
0.30 |
|
Applied Cognition-General Concerns |
-0.9 [-6.2, 2.3] |
0.0 [-3.8, 4.1] |
-0.8 [-6.9, 7.1] |
0.47 |
|
Depression |
-1.5 [-7.2, 2.8] |
0.0 [-4.7, 5.5] |
3.7 [-7.0, 10.2] |
0.15 |
|
Fatigue |
-1.6 [-6.6, 3.5] |
0.0 [-5.2, 4.3] |
-1.5 [-3.9, 5.5] |
0.51 |
|
Mobility |
1.2 [-1.8, 3.4] |
0.0 [-3.9, 2.3] |
0.0 [-2.7, 2.6] |
0.26 |
|
Pain Behavior |
-1.3 [-4.3, 1.7] |
0.0 [-3.7, 2.6] |
1.0 [-2.8, 4.8] |
0.07 |
|
Pain Interference |
0.0 [-6.7, 0.4] |
0.0 [-2.5, 4.1] |
2.5 [-2.7, 5.4] |
0.02 |
|
Physical Function |
1.3 [-1.2, 4.7] |
0.1 [-2.3, 2.4] |
-1.2 [-4.2, 1.9] |
0.02 |
|
Satisfaction with Social Roles & Activities |
1.8 [-2.4, 5.0] |
0.0 [-4.6, 4.8] |
0.0 [-5.8, 3.4] |
0.21 |
|
Sleep Disturbance |
0.0 [-5.9, 2.5] |
-1.5 [-5.7, 1.8] |
-0.4 [-4.3, 5.1] |
0.50 |
|
Sleep-Related Impairment |
-0.8 [-7.6, 5.4] |
0.0 [-6.7, 4.4] |
-0.2 [-3.7, 5.2] |
0.95 |
|
SELENA-SLEDAI (Possible score range from 0 to 46) |
≥ 3 point decrease (n=37) |
< 3 point change (n=128) |
≥ 3 point increase (n=31) |
p-value |
|
Ability to Participate in Social Roles |
0.0 [-3.0, 1.9] |
0.0 [-3.6, 4.8] |
-0.1 [-4.0, 2.3] |
0.66 |
|
Anger |
-4.1 [-9.8, 2.8] |
-1.9 [-6.5, 3.5] |
-0.9 [-6.1, 7.7] |
0.38 |
|
Anxiety |
-2.5 [-9.2, 1.9] |
-0.5 [-5.8, 3.4] |
-1.8 [-5.7, 0.0] |
0.40 |
|
Applied Cognition-Abilities |
3.0 [0.0, 8.4] |
-0.1 [-4.4, 3.3] |
0.0 [-1.8, 3.9] |
0.01 |
|
Applied Cognition-General Concerns |
0.0 [-2.1, 3.2] |
0.0 [-5.2, 2.8] |
0.0 [-8.5, 7.7] |
0.62 |
|
Depression |
0.0 [-7.2, 7.3] |
0.0 [-6.0, 4.4] |
0.0 [-5.3, 4.0] |
0.81 |
|
Fatigue |
-1.5 [-4.7, 2.9] |
-0.1 [-5.5, 4.6] |
-2.2 [-3.9, 7.0] |
0.93 |
|
Mobility |
0.6 [-1.2, 2.0] |
0.0 [-2.6, 2.8] |
1.4 [-5.8, 4.2] |
0.84 |
|
Pain Behavior |
0.0 [-5.4, 1.7] |
-0.1 [-3.5, 2.6] |
-0.5 [-2.7, 4.3] |
0.59 |
|
Pain Interference |
-1.3 [-6.5, 1.0] |
0.0 [-2.6, 4.1] |
0.0 [-5.4, 6.6] |
0.07 |
|
Physical Function |
0.1 [-1.6, 3.4] |
0.5 [-2.2, 3.4] |
0.2 [-3.8, 4.5] |
0.89 |
|
Satisfaction with Social Roles & Activities |
1.6 [-2.5, 4.2] |
0.0 [-4.0, 5.1] |
-1.5 [-8.1, 4.9] |
0.48 |
|
Sleep Disturbance |
-1.5 [-7.0, 1.1] |
0.0 [-5.0, 2.8] |
-2.3 [-5.1, 1.6] |
0.60 |
|
Sleep-Related Impairment |
-0.6 [-3.1, 5.8] |
0.0 [-7.4, 4.4] |
0.0 [-6.6, 5.9] |
0.54 |
|
Physician Global Assessment (Possible score range from 0 to 3) |
≥ 1 point decrease (n=22) |
< 1 point change (n=151) |
≥ 1 point increase (n=13) |
p-value |
|
Ability to Participate in Social Roles |
0.1 [-3.0, 3.2] |
0.0 [-3.6, 4.6] |
-1.6 [-5.0, 0.0] |
0.25 |
|
Anger |
0.4 [-6.1, 7.7] |
-2.8 [-7.8, 3.5] |
0.2 [-3.3, 7.7] |
0.10 |
|
Anxiety |
0.4 [-4.5, 6.1] |
-1.6 [-6.9, 2.1] |
-0.2 [-3.6, 8.0] |
0.17 |
|
Applied Cognition-Abilities |
0.0 [-3.4, 3.5] |
0.0 [-3.7, 3.9] |
1.9 [-1.8, 6.7] |
0.72 |
|
Applied Cognition-General Concerns |
1.4 [-1.3, 4.9] |
0.0 [-5.3, 2.8] |
1.5 [-8.0, 5.1] |
0.18 |
|
Depression |
2.1 [-4.5, 6.3] |
0.0 [-6.8, 4.3] |
3.4 [-2.4, 8.7] |
0.26 |
|
Fatigue |
-0.7 [-6.4, 3.3] |
-0.8 [-5.3, 3.7] |
-1.6 [-3.4, 7.0] |
0.83 |
|
Mobility |
0.1 [-2.5, 1.8] |
0.0 [-2.5, 2.9] |
-0.8 [-6.2, 3.6] |
0.52 |
|
Pain Behavior |
0.0 [-2.8, 3.1] |
-0.5 [-4.2, 2.2] |
-0.9 [-2.7, 4.3] |
0.60 |
|
Pain Interference |
0.0 [-4.5, 4.0] |
0.0 [-4.6, 3.2] |
0.8 [-2.7, 6.1] |
0.50 |
|
Physical Function |
0.1 [-4.2, 4.2] |
0.7 [-2.1, 3.5] |
-1.2 [-3.0, 0.7] |
0.48 |
|
Satisfaction with Social Roles & Activities |
-1.9 [-6.3, 4.2] |
0.0 [-3.2, 5.0] |
0.0 [-6.2, 5.8] |
0.39 |
|
Sleep Disturbance |
0.3 [-4.7, 5.2] |
-1.1 [-5.6, 1.7] |
0.6 [-5.1, 5.1] |
0.25 |
|
Sleep-Related Impairment |
0.7 [-1.6, 5.8] |
-0.6 [-7.7, 4.6] |
0.1 [-2.1, 5.9] |
0.15 |
To cite this abstract in AMA style:
Kasturi S, Szymonifka J, Berman JR, Kirou KA, Levine AB, Sammaritano LR, Mandl LA. Responsiveness of Patient Reported Outcomes Measurement Information System (PROMIS®) Computerized Adaptive Tests (CATs) in Systemic Lupus Erythematosus (SLE) [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/responsiveness-of-patient-reported-outcomes-measurement-information-system-promis-computerized-adaptive-tests-cats-in-systemic-lupus-erythematosus-sle/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/responsiveness-of-patient-reported-outcomes-measurement-information-system-promis-computerized-adaptive-tests-cats-in-systemic-lupus-erythematosus-sle/