Reliability and Validity of Patient-reported Outcomes Measurement Information System Short Forms in Ankylosing Spondylitis

Abstract

Objective To assess the reliability and validity in ankylosing spondylitis (AS) of selected Patient Reported Outcomes Measurement Information System (PROMIS) Short Forms (SF) developed by the US National Institutes of Health. The analysis was done across core sets and patient-identified domains of the Assessment of Spondyloarthritis international Society. Methods Participants in the Prospective Study of Outcomes in Ankylosing Spondylitis (PSOAS), an ongoing, prospective longitudinal observational study, completed 6 PROMIS SF assessing global health, depression, fatigue, physical function, pain intensity, and pain interference during their PSOAS visits from September 2017 to January 2019. Test-retest reliability and internal consistency were assessed using intraclass correlation coefficients and Cronbach’s alpha coefficient, respectively. PROMIS SF were compared to legacy measures collected. Construct validity was evaluated through examination of score distributions and floor effects, and through examination of the Spearman correlation coefficients between PROMIS measures and existing legacy AS measures. Discriminant validity was tested across Ankylosing Spondylitis Disease Activity Score (ASDAS) groups. Results Participants (n = 119) were mostly male (69%), white (81%), and with a mean (SD) age of 51 (± 15) years. Legacy measures demonstrated floor effects that were not present in PROMIS SF. Good test-retest reliability (r > 0.8) and excellent internal consistency (α > 0.9) was noted in the PROMIS SF. The 6 PROMIS SF correlated moderately to strongly [ρ 0.68 (Depression) to –0.87 (Physical Function)] with appropriate legacy measures. PROMIS scores measures worsened significantly (p < 0.05) with higher ASDAS groups. Conclusion This study supports the reliability and construct validity of PROMIS SF to assess AS symptoms from a single-center sample of patients with AS. Further research is needed to test responsiveness, feasibility/resource burden, and different cultural/societal contexts for patients with AS.

Adult Measures of General Health and Health‐Related Quality of Life

“…In a study of 119 patients with ankylosing spondylitis, Hwang et al reported that the PROMIS‐GH version 1.1 GPH scale had no floor effects. Of note, this study focuses on GPH only . Finally, Kahan et al did not find floor or ceiling effects among 62 patients with lateral epicondylitis for the GPH scale but identified a minor ceiling effect for the GMH scale in one subgroup .…”

“…The internal consistency of the PROMIS‐GH in rheumatic conditions has only been assessed in one study. A Cronbach's α of 0.91 has been reported for the PROMIS‐GH version 1.1 GPH scale in a study with 119 patients with ankylosing spondylitis . More broadly, the original authors of the PROMIS‐GH report internal consistencies of 0.81 and 0.86 for the GPH and GMH scales, respectively .…”

“…There is little evidence that the PROMIS‐GH exhibits floor or ceiling effects in rheumatology settings. For example, in a study of 161 individuals with shoulder arthritis, no floor or ceiling effects were recorded for either GPH or GMH . In a study of 119 patients with ankylosing spondylitis, Hwang et al reported that the PROMIS‐GH version 1.1 GPH scale had no floor effects.…”

General Functional Status: Common Outcome Measures for Adults With Rheumatic Disease

“…Test‐retest reliability was excellent in the PROMIS PF‐10a in patients with OA (ICC = 0.95) and in the PF‐12a in patients with ankylosing spondylitis (ICC = 0.96) . Internal consistency is high in many versions (4a, 6b, 8b, 10a, 12a, 16 [custom], and 20a) tested in patients with various rheumatic diseases, including fibromyalgia, ankylosing spondylitis, SLE, cancer, and chronic conditions (Cronbach's α = 0.87‐0.96) . PROMIS short forms have strong reliability among methods of administration (paper, personal digital assistant, interactive voice response, and personal computer; ICC > 0.9) .…”

“…PROMIS PF short forms (4a, 6b, 8b, 10a, 12a, 16 [custom], and 20a) demonstrated moderate to strong correlations with other PF measures, including the PF‐10, the HAQ DI, WOMAC function subscale, pain, the 6‐Minute Walk Test, gait speed, global assessment of RA activity, the Revised Fibromyalgia Impact Questionnaire function subscale, the Bath Ankylosing Spondylitis Disease Activity Index, the Systemic Lupus Activity Questionnaire, and the Functional Assessment of Cancer Therapy Physical Well‐Being subscale. Associations were evaluated in a variety of patient populations, including patients with RA, OA, fibromyalgia, ankylosing spondylitis, SLE, and other chronic conditions affecting older adults (( r or ρ = 0.50‐0.90) .…”