Validation of the PROMIS sleep disturbance item bank computer adaptive test (CAT) in patients on renal replacement therapy

Abstract

ObjectiveTo examine the validity and reliability of the PROMIS Sleep Disturbance Item Bank Computer Adaptive Test (PROMIS-SD CAT) in patients on renal replacement therapy, using the Insomnia Severity Index as the primary legacy instrument. MethodsCross-sectional sample of adults on renal replacement therapy completed PROMIS-SD CAT, Insomnia Severity Index, General Anxiety Disorder-7, Edmonton Symptom Assessment System-revised Renal, SF-12 questionnaires. Construct validity was confirmed by associations with legacy instrument scores and measures of emotional wellbeing. Test-retest and scale reliability were assessed using intraclass correlation coefficient and standard errors of measurement, respectively. Discrimination was assessed using receiver-operating characteristic curve analysis. ResultsAmong 217 participants (133 kidney transplant recipients, 84 on dialysis), 15% had moderate/severe sleep disturbance (Insomnia Severity Index ≥15). PROMIS-SD CAT exhibited good test-retest (intraclass correlation coefficient = 0.89, 95% confidence interval (0.83–0.93)) and scale (>0.9 for T-scores 34–73) reliability. PROMIS-SD CAT T-scores were strongly correlated with Insomnia Severity Index (rho = 0.85, 95% confidence interval (0.81–0.88)), Edmonton Symptom Assessment System-revised Renal Sleep Item (rho = 0.75, 95% confidence interval (0.69–0.81)) and moderately with General Anxiety Disorder-7 scores and SF-12 Mental Component Summary scores (p < 0.001 for all). PROMIS-SD CAT demonstrated outstanding discrimination for moderate/severe insomnia (defined as Insomnia Severity Index ≥15) (AUROC 0.93, 95% confidence interval (0.88, 0.98)). PROMIS-SD CAT and Insomnia Severity Index measurement characteristics were qualitatively similar between patients on dialysis and kidney transplant recipients. ConclusionsThese results support PROMIS-SD CAT's validity and reliability for research and as potential screening tool among patients on renal replacement therapy.