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

ABSTRACT

OBJECTIVE: To 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. METHODS: Cross-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. RESULTS: Among 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. CONCLUSIONS: These results support PROMIS-SD CAT's validity and reliability for research and as potential screening tool among patients on renal replacement therapy.