Validation of a core patient-reported outcome measure of life participation in people with chronic kidney disease: SONG Life Participation Instrument

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Abstract Title *

Validation of a core patient-reported outcome measure of life participation in people with chronic kidney disease: SONG Life Participation Instrument

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Co-author 1

Anastasia Hughes anastasia.hughes@sydney.edu.au University of Sydney Sydney School of Public Health Sydney Australia *

Co-author 2

Cameron Burnett cameron.burnett@health.qld.gov.au Princess Alexandra Hospital Department of Kidney and Transplant Services Brisbane Australia -

Co-author 3

Angela Ju angela.ju@sydney.edu.au University of Sydney Sydney School of Public Health Sydney Australia -

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Allison Jaure allison.jaure@sydney.edu.au University of Sydney Sydney School of Public Health Sydney Australia -

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Introduction

Life participation has been identified as a critically important core outcome by people with chronic kidney disease (CKD) not yet requiring kidney replacement therapy (KRT). In this study we aimed to validate a patient-reported outcome measure for life participation in adults with CKD not yet requiring KRT.

Methods

A psychometric evaluation of the Standardised Outcomes in Nephrology Life Participation (SONG-LP) instrument was conducted in adults with CKD not yet requiring KRT. The measure includes four domains of life participation including leisure, family, work and social activities on a five-point Likert scale scored from never (0) to always (4) with the summary score the mean of each item. Internal consistency, test-retest reliability, convergent validity, and known group testing.

Results

In total, 179 people with chronic kidney disease not yet requiring kidney replacement therapy from 16 countries participated. The SONG-LP instrument demonstrated strong internal consistency (Cronbach’s a = 0.93, 95% confidence interval [CI] (0.91-0.94) baseline) and strong test-retest reliability over one week (intraclass correlation coefficient of 0.9; 95% CI: 0.87-0.93). The mean scores for the SONG-LP instrument were 2.97 (standard deviation [SD] 0.91, baseline) and 3.07 (SD 0.92, one-week). There was strong positive correlation (0.81; 95% CI: 0.72-0.86) with the PROMIS Ability to Participate in Social Roles and Activities Short Form8a assessing a similar construct, and moderate correlation with measures that assessed related concepts including EQ5D (0.72; 95% CI: 0.63-0.79), and PROMIS Cognitive Functional Abilities Subset Short Form 4a (0.61; 95% CI: 0.50-0.70).

Conclusion

The SONG-LP instrument is a valid, reliable and internally consistent instrument to assess life participation in people with CKD not yet requiring KRT. It is simple and easy to use enabling routine collection in all CKD clinical trials ensuring consistent assessment of the relevant and meaningful outcome of life participation leading to informed decision making.

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