PROMIS®-SF Accurately Measures Patient Reported Outcomes In Childhood-Onset SLE

The pediatric Patient Reported Outcomes Measurement Information System Short Forms (PROMIS®-SFs) have been found to be an accurate and easily administered patient reported outcome measure of childhood-onset systemic lupus erythematosus (cSLE), demonstrating construct validity, internal consistency, and responsiveness to change in a clinical setting, according to research published in Arthritis Care & Research.

“Traditional disease measures or physician assessment of disease activity have proven insufficient to accurately assess the impact of cSLE disease on patient health-related quality of life (HRQoL),” wrote Hermine Brunner, MD, Professor of Pediatrics and Director of the Division of Rheumatology at the Cincinnati Children’s Hospital Medical Center and colleagues.

 “Hence, various patient-reported outcomes (PROs) have been developed and validated in cSLE to provide complementary information in support of optimal patient management and heightened satisfaction with care.”

In order to make full use of PROMIS to measure cSLE patient reported outcomes, the short forms required validation to determine their measurement properties. The researchers’ objectives in this study were to investigate feasibility, internal consistency, construct validity, and responsiveness to change of the PROMIS-SFs in a clinical setting.

The researchers recruited 100 participants with cSLE with a mean age of 15.8 (range: 10-20 years), and had them complete the PROMIS-SFs at 3 study visits. The PROMIS-SFs evaluated anger, anxiety, depressive symptoms, fatigue, physical function-mobility, physical function-upper extremity, pain interference, and peer relationships.

The participants also completed the HRQoL legacy measures, which included the Pediatric Quality of Life Inventory™, Childhood Health Assessment Questionnaire, Simple Measure of Impact of Lupus Erythematosus in Youngsters (SMILEY), and visual analog scales (VAS) of pain and well-being. All questionnaires were child self-report, except for the Child Health Questionnaire (CHQ-PF50), which was a parent proxy-report.

At each study visit, physicians also rated cSLE activity on a VAS, completed the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), and rated the change of overall disease activity (GRC-MD1: better/same/worse) and change of patient overall health (GRC-MD2: better/same/worse) between study visits with a global rating scale of change.

The researchers found that the PROMIS-SF scores were completed in less than 5 minutes, demonstrating feasibility, and also demonstrated internal consistency, construct validity, and responsiveness to change. The scores correlated at least moderately (Pearson’s r ≥ .5) with those of legacy HRQoL, except for the SMILEY. The PROMIS-SFs’ responsiveness to change was also supported by path, mixed model, and correlation analysis. Unlike some HRQoL measures, measures of cSLE activity or damage did not correlate with the PROMIS-SFs.

Summary and Clinical Applicability

“Our findings [are] that PROMIS-SFs offer a valid option to efficiently collect PROs in cSLE in a clinical setting, given outstanding feasibility and minimal time burden,” the researchers wrote.

“In this study, the entire battery of PROMIS-SFs was completed in approximately 5 minutes, which equates to less than 1 minute per domain… This supports a decreased respondent burden when compared with legacy measures that require 5 to 15 minutes each for completion.”

Limitations and Disclosures

As in many pediatric rheumatology studies, the sample size was limited, which likely contributed to the difficulty in demonstrating responsiveness to change for all of the PROMIS-SFs included in the study, especially pertaining to worsening of cSLE and overall health. However, 3 complementary strategies to support sensitivity to change were included, suggesting that PROMIS-SFs are suitable for capturing clinically relevant changes in HRQoL in cSLE. 

The majority of patients were also teenagers, meaning findings may differ in younger children — however, children as young as age 10 were included. The study also took place at 2 centers, so study center bias cannot be excluded. 

Reference

Jones JT, Carle AC, Wootton J, et al. Validation of Patient-Reported Outcomes Measurement Information System (PROMIS®) Short Forms for Use in Childhood-onset Systemic Lupus Erythematosus. Arthritis Care Res. 2016; doi:10.1002/acr.22927.