Validation of Patient-Reported Outcomes Measurement Information System (PROMIS®) Modules for Use in Childhood-Onset Lupus

Jordan T. Jones¹, Janet Wootton², Jun Ying³, Brianna Liberio⁴, Jiha Lee⁵, Adam Carle⁶, Laura Schanberg² and Hermine I. Brunner⁶, ¹Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ²Pediatrics, Duke Medical Center, Durham, NC, ³University of Cincinnati, Cincinnati, OH, ⁴University of Cincinnati College of Medicine, Cincinnati, OH, ⁵Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, ⁶Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Meeting: ACR/ARHP Annual Meeting 2015

Date of first publication: September 29, 2015

Keywords: patient outcomes, Pediatric rheumatology, Quality of life and systemic lupus erythematosus (SLE), Validity

Session Information

Date: Tuesday, November 10, 2015

Title: ACR/ARHP Combined Abstract Session: Pediatric Rheumatology

Session Type: ACR/ARHP Combined Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: Childhood-onset lupus (cSLE) has a substantial negative impact on health-related quality of life (HRQoL). Patient-reported outcomes (PROs) that accurately assess HRQoL and are responsive to change can contribute to improvements in clinical care, and treatment decisions. The PRO Measurement Information System (PROMIS^®, http://nihpromis.org) is a publicly available system, supported by the National Institute of Health that measures PROs. Although several accepted legacy HRQoL measures exist for cSLE, the goals of PROMIS are to decrease respondent burden, increase comparison diseases, and increase responsiveness of measured domains. Our objectives were to investigate the validity and responsiveness of the pediatric PROMIS short forms in cSLE in a clinical setting.

Methods: In a longitudinal study 100 cSLE patients completed pediatric PROMIS short forms (anger, anxiety, depressive, fatigue, mobility, upper extremity function, pain interference, peer relations) and legacy HRQoL measures (Pediatric Quality of Life Inventory™ Generic Core [GC] & Rheumatology Modules [RM], Childhood Health Assessment Questionnaire [CHAQ], Functional Disability Inventory [FDI], and parents completed Child Health Questionnaire [CHQ]) at three study visits approximately three to six months apart. We used legacy measures, physician reported health status change, cross-sectional correlations, and path analyses to evaluate construct validity and responsiveness to change for PROMISscores.

Results: Participants (80% female; 33% White, 48% Black, 8% other) had a mean age of 15.8 years (SD 2.2) and SLEDAI score of 6.0 (SD 5.9). Completion of the PROMIS short forms averaged seven minutes in total (legacy measures 5 to15 minutes each). Validity of the pediatric PROMISshort forms is supported by moderate to high correlations (Pearson’s r ≥ 0.5) with the scores of various legacy measures (Table 1), and with similar PROMIS domains, respectively, and dissimilar PROMISdomains having low correlations (Pearson’s r ≤ 0.4). Path analyses showed that physician reported changes (e.g., improvement from visit 1 to visit 2) corresponded to parallel change in PROMIS scores (see Table 2). Moreover, the changes were largest for HRQoL scores more closely aligned with clinical change.

Conclusion: The pediatric PROMIS short form measures of HRQoL demonstrated construct validity, and responsiveness to change in a sample of children with cSLE. PROMIS measures can be utilized by clinicians treating cSLE for a more efficient, responsive measure of HRQoL while reducing respondent and clinician time burden.

Table 1. Bivariate correlations between pediatric PROMIS^® short forms and legacy measures
Pediatric PROMIS Short Forms Domains	Anger	Anxiety	Depression	Fatigue	Mobility	Upper Extremity Function	Pain Interference	Peer Relationships
SLEDAI*	0.12	0.06	0.03	0.11	-0.23	-0.12	0.16	0.11
CHQ – Psychosocial Summary Score (PsS)	-0.37	-0.32†	-0.33†	-0.35†	0.43†	0.21	-0.36†	0.32†
CHQ – Physical Summary Score (PhS)	-0.15	-0.24	-0.20	-0.36†	0.55†	0.31†	-0.40†	0.03
CHAQ	0.23	0.29	0.27	0.42†	-0.67†	-0.71†	0.46†	-0.11
PedsQL – GC	-0.58†	-0.66†	-0.64†	-0.78†	0.70†	0.39†	-0.74†	0.30†
PedsQL – RM	-0.53†	-0.65†	-0.60†	-0.72†	0.61†	0.42†	-0.72†	0.24
SMILEY	0.27	0.25	0.25	0.27	-0.19	-0.06	0.30†	0.03
Functional Disability Inventory (FDI)	0.37†	0.47†	0.42†	0.62†	-0.73†	-0.49†	0.62†	-0.18
Values are correlation coefficients † Represent p-value < 0.05 * Systemic Lupus Erythematosus Disease Activity Index 2000

Table 2. Change in PROMIS^®short form domain score^† between visits
Variable Category		Anger	Anxiety	Depression	Fatigue	Mobility	Upper Extremity Function	Pain	Peer Relationships
Visit 2	Better	-0.73 (0.26)*	-0.34 (0.22)	-0.36 (0.26)	-0.65 (0.28)*	0.39 (0.24)	0.66 (0.28)*	-0.55 (0.25)*	-0.19 (0.29)
Visit 2	Worse	-0.17 (0.38)	-0.18 (0.35)	0.03 (0.33)	-0.31 (0.46)	0.28 (0.29)	0.57 (0.30)	-0.32 (0.33)	0.43 (0.38)
Visit 3	Better	0.05 (0.15)	-0.10 (0.13)	0.03 (0.16)	0.01 (0.15)	0.26 (0.14)	0.14 (0.14)	-0.12 (0.13)	0.07 (0.17)
Visit 3	Worse	0.18 (0.17)	0.09 (0.15)	0.05 (0.17)	0.01 (0.15)	-0.44 (0.14)*	-0.16 (0.14)	0.30 (0.18)	-0.12 (0.18)
† Values are standardized coefficients (Standard Error) * Represents p-value < 0.05

Disclosure: J. T. Jones, None; J. Wootton, None; J. Ying, None; B. Liberio, None; J. Lee, None; A. Carle, None; L. Schanberg, None; H. I. Brunner, None.

To cite this abstract in AMA style:

Jones JT, Wootton J, Ying J, Liberio B, Lee J, Carle A, Schanberg L, Brunner HI. Validation of Patient-Reported Outcomes Measurement Information System (PROMIS®) Modules for Use in Childhood-Onset Lupus [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/validation-of-patient-reported-outcomes-measurement-information-system-promis-modules-for-use-in-childhood-onset-lupus/. Accessed .

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