The Feasibility And Validity Of Patient Reported Outcome Measurement Information System (Promis) In Systemic Lupus Erythematosus
Background: Accurate measurement of patient reported outcomes (PROs) is crucial to understanding how poor health impacts quality of life. PROs are particularly important in chronic diseases such as systemic lupus erythematosus (SLE), where disease manifestations are protean and objective measures may not capture patient centered domains. Patient Reported Outcome Measurement Information System (PROMIS) offers dynamic computerized adaptive tests (CATs) which have the potential to efficiently and accurately measure PROs that are relevant to SLE patients. Objectives: The aims of this study were to: 1) assess the feasibility of administering PROMIS CATS to SLE outpatients; 2) assess the validity of PROMIS CATs by correlating them with legacy PRO measures; 3) correlate PROMIS CATs with standard measures of SLE disease activity and organ damage; 4) assess retest reliability of PROMIS CATs. Methods: Adults meeting American College of Rheumatology SLE classification criteria were recruited from a SLE Center of Excellence. Subjects completed the Short Form-36 (SF-36), LupusQoL-US, and selected PROMIS CATs in domains of physical, mental and social health. SLE disease activity, flare, and damage were evaluated with the SELENA-SLEDAI and SLICC-ACR damage index. Subjects self-reported demographic information, relevant comorbid conditions, and their subjective experience completing the survey. PROMIS CATs were compared with disease activity, damage, and similar domains in legacy instruments using Spearman correlations (r). Retest reliability was evaluated among subjects reporting stable SLE activity at two assessments one week apart using intraclass correlation coefficients (ICC). Results: Of 238 outpatients approached, 204 (86%) completed at least one assessment, with 164 (80%) completing the assessment offsite. One hundred and sixty-two subjects (79%) completed a retest. There were no significant differences in demographic or clinical characteristics between those who completed the initial assessment and those who did not. Flaring patients completed the retest assessment less frequently (p = 0.03). Subjects found the questions relevant and validating. PROMIS CATs showed favorable performance characteristics and moderate to strong correlations with similar domains in both legacy instruments (r = 0.49 to 0.83, p < 0.0001). However, correlations between PROMIS CATs and the SELENA-SLEDAI and SLICC-ACR damage index were generally weak and statistically insignificant. PROMIS CAT retest ICCs were good to excellent, ranging from 0.72 to 0.88. Conclusion: To our knowledge, these data are the first to show that PROMIS CATs can be successfully administered to a diverse cohort of SLE patients at the point of care or remotely, and are valid and reliable for many SLE relevant domains. Importantly, PROMIS scores did not correlate well with physician-derived measures. This disconnect between objective signs and symptoms and the subjective patient disease experience underscores the crucial need to integrate PROs into clinical care to ensure optimal disease management.
Clinical; Epidemiology; Health; Research; Services
Clinical Epidemiology & Health Services Research
Master of Science
Attribution-NonCommercial-NoDerivatives 4.0 International
dissertation or thesis
Except where otherwise noted, this item's license is described as Attribution-NonCommercial-NoDerivatives 4.0 International