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Study investigates validity, reliability of PROMIS CAT for patients with lupus
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For patients with systemic lupus erythematosus, researchers of this study found the Patient Reported Outcomes Measurement Information System Computerized Adaptive Test correlated with findings from the SF-36 and Lupus Quality of Life Tests and showed fewer floor and ceiling effects.
“Our study is the first, to our knowledge, to demonstrate the validity and reliability of [Patient Reported Outcomes Measurement Information System Computerized Adaptive Test] PROMIS CAT in outpatients with [systemic lupus erythematosus] SLE,” the researchers wrote. “PROMIS CAT are an efficient method of evaluating [health-related quality of life] HRQoL in patients with SLE. They provide an accurate metric for measuring relevant patient domains, and future work should evaluate their performance in both clinical research and routine clinical care,” Shanthini Kasturi, MD, MS, at Weill Cornell Medicine, and colleagues wrote.
Researchers assessed the test-retest reliability of PROMS CAT with another test 7 days after the initial test. In the second test, patients were asked to identify any change in disease activity. If they responded with anything other than “about the same,” their test was excluded from the analysis.
In total, 204 patients completed the questionnaire and 162 completed the re-test within 1 week. Of the patients, 93% were women and the average age was 40 years.
The physical function measure of the PROMIS CAT correlated with the SF-36 and LupusQoL (r = 0.81 to 0.86), as well as with the SF-36 physical component summary (PCS) (r = 0.75 to 0.81). In addition, pain interference for PROMIS CAT correlated with both SF-36 and LupusQoL (r = –0.79). Fatigue for the measure correlated more strongly with LupusQoL (r = –0.75) than with vitality on the SF-36 (r = –0.67); anger, anxiety and depression for the measure correlated with the emotional health measure on the LupusQoL (r = –0.69 to –0.75) and mental health on the SF-36 (r = –0.49 to –0.76); and social function for the measure correlated with SF-36 and LupusQoL (r = 0.55 to 0.75).
Of the 162 patients who completed the re-test, 90 reported no change in disease activity. Of these 90 patients, the intraclass correlation coefficient was greater than 0.7 for all domains.
In addition, PROMIS CAT had smaller floor and ceiling effects compared with the SF-36 and LupusQoL, with fewer than 5% of patients who scored the lowest or highest possible scores. The floor and ceiling effects of SF-36 and LupusQoL were consistent with previous studies, the authors noted.
However, for physician-derived measures, PROMIS CAT only correlated with physical function and pain (r = 0.27 to 0.37).
“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,” the researchers wrote. – by Will A. Offit
Disclosure: The researchers report support by the Rheumatology Research Foundation Scientist Development Award.
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