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Validation of the Patient Reported Outcomes Measurement Information System (PROMIS) -57 and -29 Item Short Forms among Kidney Transplant Recipients


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Date
2019

Authors
Evan Tang, Oladapo Ekundayo, John Devin Peipert, Nathaniel Edwards, Aarushi Bansal, Candice Richardson, Susan J. Bartlett, Doris Howell, Madeline Li, David Cella, Marta Novak, Istvan Mucsi

Subject
Quality of Life Research

Abstract
OBJECTIVE: The Patient-Reported Outcomes Measurement Information System (PROMIS) aims to address the lack of generalizable and universal measure of patient-reported outcomes to assess health-related quality of life. It has not been validated for patients with chronic kidney disease. We aim to validate the PROMIS-57 and PROMIS-29 questionnaires among kidney transplant recipients. METHODS: A cross-sectional sample of stable kidney transplant recipients was recruited. Each participant completed PROMIS-57, a 57-question instrument covering seven domains-physical function, anxiety, depression, fatigue, pain, sleep disturbance, and social functioning-alongside validated legacy questionnaires [Patient Health Questionnaire (PHQ9), General Anxiety Disorder (GAD7), Edmonton Symptom Assessment Scale revised (ESASr), and Kidney Disease Quality of Life (KDQoL-36)]. PROMIS-29, a 29-question instrument, is nested within PROMIS-57 and measures the same domains. Structural validity of PROMIS was assessed with confirmatory factor analysis, reported using the Comparative Fit Index (CFI). Construct validity was assessed with known-groups comparisons. Internal consistency was evaluated with Cronbach's α and convergent validity was assessed with Spearman's Rho. Test-retest reliability was assessed through the intraclass correlation coefficient (ICC). RESULTS: Mean (± SD) age of the 177 participants was 50 (± 17), 57% were male and 55% Caucasian. Internal consistency of each domain was high (Cronbach's α > 0.88). Confirmatory factor analysis showed good structural validity for most domains (CFI > 0.95, RMSEA < 0.05). Test-retest reliability indicated good agreement (ICC > 0.6). Known-groups comparisons by clinical and socio-demographic differences were found as hypothesized. CONCLUSIONS: Our results provide evidence that PROMIS-57 and PROMIS-29 are highly reliable and valid instruments among kidney transplant recipients. We propose it as a valuable tool to assess important domains of the illness experience.