1024 The Journal of Rheumatology 2017; 44:7; doi:10.3899/jrheum.161202 Validity and Reliability of Patient Reported Outcomes Measurement Information System Computerized Adaptive Tests in Systemic Lupus Erythematosus Shanthini Kasturi, Jackie Szymonifka, Jayme C. Burket, Jessica R. Berman, Kyriakos A. Kirou, Alana B. Levine, Lisa R. Sammaritano, and Lisa A. Mandl ABSTRACT. Objective. The aims of this study were to assess the construct validity and the test-retest reliability of Patient Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests (CAT) in patients with systemic lupus erythematosus (SLE). Methods. Adults with SLE completed the Medical Outcomes Study Short Form-36, LupusQoL-US version (“legacy instruments”), and 14 selected PROMIS CAT. Using Spearman correlations, PROMIS CAT were compared with similar domains measured with legacy instruments. CAT were also correlated with the Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) disease activity and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) scores. Test-retest reliability was evaluated using ICC. Results. There were 204 outpatients with SLE enrolled in the study and 162 completed a retest. PROMIS CAT showed good performance characteristics and moderate to strong correlations with similar domains in the 2 legacy instruments (r = –0.49 to 0.86, p < 0.001). However, correlations between PROMIS CAT and the SELENA-SLEDAI disease activity and SDI were generally weak and statistically insignificant. PROMIS CAT test-retest ICC were good to excellent, ranging from 0.72 to 0.88. Conclusion. To our knowledge, these data are the first to show that PROMIS CAT 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 patient-reported outcomes into clinical care to ensure optimal disease management. (First Release April 15 2017; J Rheumatol 2017;44:1024–31; doi:10.3899/jrheum.161202) Key Indexing Terms: SYSTEMIC LUPUS ERYTHEMATOSUS PATIENT OUTCOME ASSESSMENT QUALITY OF LIFE VALIDATION STUDY From the Division of Rheumatology/Department of Medicine, Hospital for Special Surgery; Weill Cornell Medicine, New York, New York, USA. Supported by the Rheumatology Research Foundation Scientist Development Award. S. Kasturi, MD, MS, Division of Rheumatology/Department of Medicine, Hospital for Special Surgery, and Weill Cornell Medicine; J. Szymonifka, MA, Division of Rheumatology/Department of Medicine, Hospital for Special Surgery; J.C. Burket, PhD, Healthcare Research Institute, Hospital for Special Surgery; J.R. Berman, MD, Division of Rheumatology/Department of Medicine, Hospital for Special Surgery, and Weill Cornell Medicine; K.A. Kirou, MD, Division of Rheumatology/ Department of Medicine, Hospital for Special Surgery, and Weill Cornell Medicine; A.B. Levine, MD, Division of Rheumatology/Department of Medicine, Hospital for Special Surgery, and Weill Cornell Medicine; L.R. Sammaritano, MD, Division of Rheumatology/Department of Medicine, Hospital for Special Surgery, and Weill Cornell Medicine; L.A. Mandl, MD, MPH, Division of Rheumatology/Department of Medicine, Hospital for Special Surgery and Weill Cornell Medicine. Address correspondence to Dr. S. Kasturi, Hospital for Special Surgery, 535 East 70th St., New York, New York 10021, USA. E-mail: kasturis@hss.edu Accepted for publication March 14, 2017. The accurate measurement of health-related quality of life (HRQOL), an important patient-reported outcome (PRO), is critical to providing patient-centered care. This is especially important in diseases such as systemic lupus erythematosus (SLE), in which dramatically lower mortality rates have refocused care on minimizing morbidity 1 . Physicians and patients have different perceptions of the effect of SLE. For example, patients focus on functional status whereas physi- cians focus on laboratory values 2 . Further, it is well known that SLE significantly decreases HRQOL 3 , but exactly how HRQOL should best be defined and measured is unclear. The US Food and Drug Administration, the European Medical League, and the Outcome Measures in Rheuma- tology Clinical Trials (OMERACT) group have identified HRQOL as a crucial outcome measure for clinical trials and observational studies in SLE 4,5,6 . They recommend the use of both generic and disease-specific measures that would Personal non-commercial use only. The Journal of Rheumatology Copyright © 2017. All rights reserved. www.jrheum.org Downloaded on December 11, 2021 from