Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: PROMIS offers precise, reliable generic measurement of physical, mental and social health across chronic conditions. However, little is known about the validity and performance of PROMIS instruments in rheumatoid arthritis (RA), where high levels of pain and fatigue and low physical function and mood are common.
Methods: Data are from the baseline visit of the first 125 RA patients enrolled in an ongoing study to evaluate systematically integrating patient reported outcomes (PROs) into arthritis care. Patients completed PROMIS computerized adaptive tests (CATs) assessing pain, fatigue, physical function, mood, sleep and social roles/activities using a tablet computer linked to Assessment Center in the waiting room immediately prior to the visit. Legacy measures (100 mm VAS for pain and fatigue, MHAQ) were also obtained as well as traditional clinical indicators of disease activity. PROMIS and legacy measures were compared using Spearman correlations and regression and across CDAI disease activity levels with ANOVA.
Results: Patients were mostly female (79%) and white (86%) with a mean (SD) age of 56 (13) and disease duration of 12 (9) yr; 10% were diagnosed <= 2 yr. PROMIS CATs included an average 63 (12) items requiring 12 (5-32) minutes to complete. PROMIS CATs for pain (intensity, impact), fatigue, physical function, anxiety, depression, anger, sleep (disturbance, impairment) and social roles/activities (participation, satisfaction) correlated highly with pain VAS (r's=.82-.83), fatigue VAS (r=.86) and mHAQ (r=-.74) (p's<.001). A dose-response relationship was evident in PROMIS measures across remission, low and moderate disease activity levels (except anger; see Table). Floor effects were common in legacy measures (16%, 11% and 43% for pain VAS, fatigue VAS and MHAQ, respectively) and were not common in PROMIS instruments.
Conclusion: These data contribute preliminary evidence of convergent and known groups validity and demonstrate robust psychometric performance of PROMIS instruments to assess PROs in people receiving routine RA care. PROMIS CATs can be completed relatively quickly and appear to address some of the well-recognized limitations (non-linearity, floor effects) of existing legacy measures in RA.
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Estimates of Impact and Mean Values across CDAI Disease Activity Levels on Legacy and PROMIS Measures in Rheumatoid Arthritis. |
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Variable |
B |
Effect Size (β/SE) |
Remission N=33 |
Low N=50 |
Moderate N=23 |
High N=12 |
|
Pain 100 mm VAS |
18.3 |
8.0 |
5.9 ± 7.8a |
33.8 ± 25.2b |
52.4 ± 28.2c |
54.1 ± 26.0c |
|
PROMIS Pain Intensity |
4.6 |
6.6 |
38.0 ± 7.1a |
46.0 ± 6.1b |
48.1 ± 7.4b,c |
51.7 ± 8.2c |
|
PROMIS Pain Interference |
5.6 |
7.0 |
45.9 ± 7.7a |
55.4 ± 8.5b |
58.2 ± 6.2b,c |
62.1 ± 8.5c |
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Fatigue 100 mm VAS |
18.4 |
7.1 |
12.7 ± 17.2a |
45.3 ± 29.0b,c |
57.5 ± 27.9c* |
64.3 ± 21.7c |
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PROMIS Fatigue |
5.7 |
6.7 |
46.1 ± 8.5a |
55.6 ± 8.8b |
59.5 ± 6.9c* |
62.3 ± 9.4c |
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mHAQ |
.19 |
5.1 |
0.1 ± 0.4a |
0.3 ± 0.3a |
0.5 ± 0.4b |
0.7 ± 0.4b |
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PROMIS Physical Function‡ |
-5.6 |
-7.8 |
50.3± 8.7a |
42.7 ± 7.1b |
38.2 ± 5.7c |
33.7 ± 5.6d** |
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PROMIS Anxiety |
2.6 |
3.6 |
47.5 ± 7.6a |
52.1 ± 8.9b |
51.0 ± 8.0a,b |
57.4 ± 8.3c |
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PROMIS Depression |
3.0 |
3.5 |
46.4 ± 8.5a |
49.8 ± 9.3a |
50.9 ± 9.4b* |
57.1 ± 8.6c* |
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PROMIS Anger |
2.6 |
2.9 |
45.2 ± 7.9a |
46.8 ± 9.7a |
48.9 ± 10.9a |
54.2 ± 8.8b |
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PROMIS Sleep Disturbance |
3.2 |
3.6 |
46.6 + 9.1a |
52.6 + 8.0b |
54.3 + 10.2b |
55.7 + 8.3c |
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PROMIS Sleep Impairment |
3.8 |
4.2 |
46.3 + 9.3a |
52.7 + 9.6b |
53.7 + 9.1b |
58.7 + 6.6c |
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PROMIS Social† – Participation |
-4.7 |
-5.9 |
55.2 ± 9.5a |
49.9 ± 8.2b |
46.7 ± 6.1b |
40.1 ± 6.4c |
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PROMIS Social† – Satisfaction |
-5.5 |
-6.1 |
55.7 ± 9.6a |
47.0 ± 9.6b |
44.9 ± 6.6b |
38.4 ± 7.1c |
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†Social Roles and Activities. Differing superscripts denote significantly different groups (p<.05). *p=.06; **p=.08 |
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Disclosure:
S. J. Bartlett,
None;
A. M. Orbai,
None;
T. Duncan,
None;
C. O. Bingham III,
PCORI,
2,
OMERACT officer,
6.
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