Validating the SONG-PKD Pain Instrument, a Core Outcome Measure for Pain in ADPKD

Introduction
Pain is a critically important outcome in autosomal dominant polycystic kidney disease (ADPKD); however, it is infrequently and inconsistently reported in clinical trials. This study aimed to validate the Standardized Outcomes in Nephrology-Polycystic Kidney Disease (SONG-PKD) Pain measure, which includes 3 items related to pain (frequency, severity, and impact on life participation) measured on a 5-point Likert scale, in adults with ADPKD.
Methods
A total of 316 adults with ADPKD from 21 countries participated online. The median (interquartile range) age of participants was 56 (44–66) years, 219 (69%) were female, and 222 (70%) had a university degree or higher. Participants completed a demographic questionnaire, brief medical history, and 4 pain measures at baseline. The pain measures were readministered 2 days later. Internal consistency was evaluated with Cronbach’s alpha. Test-retest reliability was assessed using intraclass correlation coefficient (ICC), and convergent validity was assessed using Spearman’s rho. Known groups comparisons for patients with or without a history of kidney complications were performed using a Mann-Whitney rank sum test.
Results
The SONG-PKD Pain measure demonstrated high internal consistency (0.94, 95% confidence interval [CI]: 0.93–0.95) and test-retest reliability (0.92, 95% CI: 0.90–0.94). There was a high convergence of SONG-PKD Pain with the Brief Pain Inventory-Short Form (BPI-SF; 0.84, 95% CI: 0.80–0.87) and a visual analog scale (VAS; 0.84, 95% CI: 0.81–0.87). There was a significant difference in the median scores of patients with and without a history of complications (4.0 vs. 0.0, P < 0.001).
Conclusion
SONG-PKD Pain instrument is a brief and simple measure that has demonstrated strong psychometric properties.

Contributors

Rosanna Cazzolli, Angela Ju, Patrizia Natale, Armando Teixeira-Pinto, Martin Howell, Allison Jaure, Ronald D. Perrone, Eva Burnette, Niek F. Casteleijn, Arlene Chapman, Jonathan C. Craig, Sarah Eastty, Ron T. Gansevoort, Tess Harris, Marie C. Hogan, Shigeo Horie, Bertrand Knebelmann, Richard Lee, Karine Manera, Reem A. Mustafa, Richard Sandford, Gopala K. Rangan, Bénédicte Sautenet, Andrea K. Viecelli, Yeoungjee Cho

Publication

Journal: Kidney International Reports
Volume: 10
Issue: 2
Pages: 447 - 456
Year: 2025
DOI: 10.1016/j.ekir.2024.11.015

Further Study Information

Current Stage: Completed
Date:
Funding source(s): RC is supported by the National Health and Medical Research Council (NHMRC) Center for Research Excellence Grant (2007026). AV is supported by an NHMRC investigator Grant (1196033) and a Queensland Advancing Clinical Research Fellowship. AJ is supported by a NHMRC Investigator Grant (1197324). The funding organization had no role in the design and conduct of this study; collection; management, analysis and interpretation of the data; or preparation, review, or approval of the manuscript. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the funding agencies.


Health Area

Disease Category: Kidney disease

Disease Name: Polycystic kidney disease

Target Population

Age Range: 18 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Consumers (patients)

Study Type

- Recommendations for outcome measures (measurement/how)

Method(s)

- Other
- Survey

A total of 316 adults with ADPKD from 21 countries participated online. The median (interquartile range) age of participants was 56 (44–66) years, 219 (69%) were female, and 222 (70%) had a university degree or higher. Participants completed a demographic questionnaire, brief medical history,
and 4 pain measures at baseline. The pain measures were readministered 2 days later. Internal consistency was evaluated with Cronbach’s alpha. Test-retest reliability was assessed using intraclass correlation coefficient (ICC), and convergent validity was assessed using Spearman’s rho. Known groups comparisons for patients with or without a history of kidney complications were performed using a Mann Whitney rank sum test.