Validation of the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 and -29 item short forms among kidney transplant recipients

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

doi:10.1007/s11136-018-2058-2

Validation of the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 and -29 item short forms among kidney transplant recipients

Qual Life Res. 2019 Mar;28(3):815-827. doi: 10.1007/s11136-018-2058-2. Epub 2018 Nov 22.

Authors

Affiliations

¹ Division of Nephrology, Multi-Organ Transplant Program, University Health Network and University of Toronto, Toronto, Canada.
² Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
³ Center for Health Outcomes Research, McGill University, Montreal, Canada.
⁴ Princess Margaret Cancer Center, Faculty of Nursing, University of Toronto, Toronto, ON, Canada.
⁵ Psychosocial Oncology, Princess Margaret Cancer Centre, Toronto, Canada.
⁶ Centre for Mental Health, University Health Network, Toronto, ON, Canada.
⁷ Division of Nephrology, Multi-Organ Transplant Program, University Health Network and University of Toronto, Toronto, Canada. istvan.mucsi@utoronto.ca.
⁸ Multi-Organ Transplant Unit, Toronto General Hospital, University Health Network, 585 University Avenue, 11-PMB-188, Toronto, ON, M5G 2N2, Canada. istvan.mucsi@utoronto.ca.

PMID: 30467780
DOI: 10.1007/s11136-018-2058-2

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.

Keywords: Kidney transplant; PROMIS; PROMIS-29; PROMIS-57; Patient-reported outcomes; Renal transplant; Validation study.

MeSH terms

Cross-Sectional Studies
Female
Humans
Kidney Transplantation / methods*
Male
Middle Aged
Patient Reported Outcome Measures*
Quality of Life / psychology*
Renal Insufficiency, Chronic / surgery*
Reproducibility of Results
Surveys and Questionnaires