Responsiveness of Patient Reported Outcomes Measurement Information System Measures in RA Patients Starting or Switching a DMARD

Alyssa Wohlfahrt¹, Clifton Bingham III², Zhi Zhang¹, Marcy Bolster³, Larry W. Moreland⁴, Tuhina Neogi⁵, Kristine Phillips⁶ and Yvonne C. Lee⁷, ¹Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ²Johns Hopkins University, Baltimore, MD, ³Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Boston, MA, ⁴Rheumatology & Clinical Immunology, University of Pittsburgh, Pittsburgh, PA, ⁵Clinical Epidemiology, Boston University School of Medicine, Boston, MA, ⁶Rheumatology, University of Michigan, Ann Arbor, MI, ⁷Rheumatology Immunology & Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Anxiety, pain, PROMIS, rheumatoid arthritis (RA) and sleep

Session Information

Date: Monday, November 14, 2016

Title: Quality Measures and Quality of Care I

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: The Patient Reported Outcome Measurement Information System (PROMIS) is an NIH-developed metric for assessing multidimensional aspects of health across different conditions. Prior RA studies have reported cross-sectional results from PROMIS measures but were limited by small numbers of patients with active inflammatory disease. The purpose of this study was to evaluate the performance of multiple PROMIS measures in active RA patients initiating DMARDs.

Methods: Subjects were the first 148 RA patients enrolled in an ongoing multi-site, prospective observational study. Inclusion required active disease necessitating a start/switch to a new DMARD based on physician assessment. Subjects were evaluated before and 12-24 weeks after DMARD initiation. Subjects completed the PROMIS Global Health v1.1 short form and the following PROMIS computer adapted tests (CATs): Pain Interference, Pain Behavior, Sleep Disturbance, Sleep Related Impairment, Fatigue, Anxiety, and Depression. Scores were T-scores standardized to a general population mean of 50 ± 10. Higher scores indicate more of the concept measured. We performed linear regression models to identify cross-sectional associations between baseline PROMIS measures and disease activity measured using the CDAI; paired t-tests to evaluate responsiveness in subjects with follow-up data; and Pearson correlations to identify associations between changes in PROMIS measures and changes in CDAI.

Results: 85% of the cohort was female. Mean RA duration was 10.1 ± 12.8 years. At baseline, the mean CDAI was 25.3 ± 14.4. In multivariable linear regression models adjusted for age, sex, race, disease duration, and seropositive status, higher CDAI categories were significantly associated with higher PROMIS scores of pain, sleep, fatigue, and anxiety and lower PROMIS scores of physical and mental health (P ≤ 0.05). Among 89 patients with pre/post data, paired t-tests showed statistically significant decreases in PROMIS domain measures (P ≤ 0.01), ranging from -3.3 ± 8.2 to -5.5 ± 7.5 (Table). PROMIS Global Profile physical scores increased by 4.6 ± 7.3 (P < 0.0001), and PROMIS Global Profile mental scores increased by 2.0 ± 7.4 (P = 0.01). Changes were significantly correlated with changes in CDAI for all measures (absolute rho’s = 0.21-0.33) except for the Global Profiles and Depression.

Conclusion: These data confirm the ability of PROMIS measures to distinguish RA patient groups based on levels of disease activity. Although minimal clinically important improvements have not been defined, our data suggest that PROMIS instruments are responsive to changes in therapy. We conclude that PROMIS measures may be useful tools for assessing RA symptoms in research studies and in routine clinical care, before and after starting a new DMARD.

Table. Mean (±SD) PROMIS Scores for RA patients before and 12-24 weeks after starting a DMARD (N = 89).
	Mean Baseline Score	Mean Follow-Up Score	Mean Change	P Value*
Physical Global Health Profile	41.7 (±7.5)	46.3 (±8.3)	4.6 (±7.3)	<0.0001
Mental Global Health Profile	48.3 (±8.6)	50.3 (±9.1)	2.0 (±7.4)	0.01
Pain Interference CAT	59.8 (±8.4)	54.5 (±8.0)	-5.5 (±7.5)	<0.0001
Pain Behavior CAT	58.9 (±5.1)	54.3 (±8.1)	-4.6 (±8.9)	<0.0001
Sleep Disturbance CAT	55.6 (±8.6)	50.96 (±9.4)	-4.7 (±9.7)	<0.0001
Sleep Related Impairment CAT	55.8 (±10.3)	51.4 (±10.8)	-4.1 (±10.0)	0.0003
Fatigue CAT	56.7 (±8.6)	51.9 (±8.9)	-4.7 (±8.7)	<0.0001
Anxiety CAT	54.4 (±8.7)	51.2 (±9.4)	-3.3 (±8.0)	0.0003
Depression CAT	50.9 (±9.1)	47.7 (±9.1)	-3.3 (±8.2)	0.0004

* P-values from paired t-tests

Disclosure: A. Wohlfahrt, None; C. Bingham III, None; Z. Zhang, None; M. Bolster, Johnson and Johnson, 1,Eli Lilly and Company, 2,RRF Amgen Fellowship Award, 9; L. W. Moreland, None; T. Neogi, None; K. Phillips, None; Y. C. Lee, None.

To cite this abstract in AMA style:

Wohlfahrt A, Bingham C III, Zhang Z, Bolster M, Moreland LW, Neogi T, Phillips K, Lee YC. Responsiveness of Patient Reported Outcomes Measurement Information System Measures in RA Patients Starting or Switching a DMARD [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/responsiveness-of-patient-reported-outcomes-measurement-information-system-measures-in-ra-patients-starting-or-switching-a-dmard/. Accessed .

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