A Core Outcome Set for Trials in Glomerular Disease: A Report of the Standardized Outcomes in Nephrology-Glomerular Disease (SONG-GD) Stakeholder Workshops

Simon A Carter^{1

2}, Liz Lightstone³, Dan Cattran^{4

5}, Allison Tong^{1

2}, Arvind Bagga⁶, Sean J Barbour⁷, Jonathan Barratt^{8

9}, John Boletis¹⁰, Dawn J Caster¹¹, Rosanna Coppo¹², Fernando C Fervenza¹³, Jürgen Floege¹⁴, Michelle A Hladunewich^{4

15}, Jonathan J Hogan¹⁶, A Richard Kitching^{17

18}, Richard A Lafayette^{19

20}, Ana Malvar²¹, Jai Radhakrishnan²², Brad H Rovin²³, Nicole Scholes-Robertson^{1

2}, Hernán Trimarchi²⁴, Hong Zhang²⁵, Samaya Anumudu²⁶, Yeoungjee Cho^{27

28

29}, Talia Gutman^{1

2}, Emma O'Lone¹, Andrea K Viecelli^{27

28}, Eric Au^{1

2}, Karolis Azukaitis³⁰, Amanda Baumgart^{1

2}, Amelie Bernier-Jean^{1

2}, Louese Dunn³¹, Martin Howell^{1

2}, Angela Ju², Charlotte Logeman², Melissa Nataatmadja^{32

33}, Benedicte Sautenet^{34

35}, Ankit Sharma^{1

2}, Jonathan C Craig³⁶; SONG-GD Workshop Investigators

Affiliations

¹ Sydney School of Public Health, The University of Sydney, Sydney, Australia.
² Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.
³ Centre for Inflammatory Disease, Faculty of Medicine, Imperial College London, London, United Kingdom.
⁴ Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
⁵ Toronto General Research Institute, Toronto, Ontario, Canada.
⁶ All India Institute of Medical Sciences, Department of Pediatrics, New Delhi, India.
⁷ Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, Canada.
⁸ Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.
⁹ John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom.
¹⁰ Department of Nephrology and Renal Transplantation, Medical School, University of Athens, Laiko Hospital, Athens, Greece.
¹¹ Division of Nephrology, University of Louisville, Louisville, Kentucky.
¹² Molinette Research Foundation, Regina Margherita Hospital, Turin, Italy.
¹³ Division of Nephrology and Hypertension, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.
¹⁴ Department of Nephrology and Clinical Immunology, RWTH University Hospital, Aachen, Germany.
¹⁵ Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
¹⁶ Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
¹⁷ Departments of Nephrology and Paediatric Nephrology, Monash Health, Clayton, Victoria, Australia.
¹⁸ Centre for Inflammatory Diseases, Department of Medicine, Monash University, Clayton, Victoria, Australia.
¹⁹ Stanford University Medical Center, Stanford, California.
²⁰ Division of Nephrology, Department of Medicine, Stanford University, Stanford, California.
²¹ Nephrology, Hospital Fernández, Buenos Aires, Argentina.
²² Columbia University Medical Center, New York, New York.
²³ Division of Nephrology, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio.
²⁴ Nephrology Service and Kidney Transplantation Unit, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina.
²⁵ Renal Division of Peking University First Hospital, Beijing, China.
²⁶ Department of Nephrology, Baylor College of Medicine, Houston, Texas.
²⁷ Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.
²⁸ Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia.
²⁹ Translational Research Institute, Brisbane, Australia.
³⁰ Clinic of Pediatrics, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
³¹ Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.
³² Department of Nephrology, Sunshine Coast University Hospital, Birtinya, Australia.
³³ Faculty of Medicine, University of Queensland, Herston, Australia.
³⁴ University Francois Rabelais, Tours, France.
³⁵ Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France.
³⁶ College of Medicine and Public Health, Flinders University, Adelaide, Australia.

PMID: 34969698
PMCID: PMC8763157
DOI: 10.2215/CJN.07840621

A Core Outcome Set for Trials in Glomerular Disease: A Report of the Standardized Outcomes in Nephrology-Glomerular Disease (SONG-GD) Stakeholder Workshops

Simon A Carter et al. Clin J Am Soc Nephrol. 2022 Jan.

. 2022 Jan;17(1):53-64.

doi: 10.2215/CJN.07840621. Epub 2021 Dec 30.

Authors

Affiliations

¹ Sydney School of Public Health, The University of Sydney, Sydney, Australia.
² Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.
³ Centre for Inflammatory Disease, Faculty of Medicine, Imperial College London, London, United Kingdom.
⁴ Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
⁵ Toronto General Research Institute, Toronto, Ontario, Canada.
⁶ All India Institute of Medical Sciences, Department of Pediatrics, New Delhi, India.
⁷ Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, Canada.
⁸ Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.
⁹ John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom.
¹⁰ Department of Nephrology and Renal Transplantation, Medical School, University of Athens, Laiko Hospital, Athens, Greece.
¹¹ Division of Nephrology, University of Louisville, Louisville, Kentucky.
¹² Molinette Research Foundation, Regina Margherita Hospital, Turin, Italy.
¹³ Division of Nephrology and Hypertension, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.
¹⁴ Department of Nephrology and Clinical Immunology, RWTH University Hospital, Aachen, Germany.
¹⁵ Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
¹⁶ Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
¹⁷ Departments of Nephrology and Paediatric Nephrology, Monash Health, Clayton, Victoria, Australia.
¹⁸ Centre for Inflammatory Diseases, Department of Medicine, Monash University, Clayton, Victoria, Australia.
¹⁹ Stanford University Medical Center, Stanford, California.
²⁰ Division of Nephrology, Department of Medicine, Stanford University, Stanford, California.
²¹ Nephrology, Hospital Fernández, Buenos Aires, Argentina.
²² Columbia University Medical Center, New York, New York.
²³ Division of Nephrology, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio.
²⁴ Nephrology Service and Kidney Transplantation Unit, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina.
²⁵ Renal Division of Peking University First Hospital, Beijing, China.
²⁶ Department of Nephrology, Baylor College of Medicine, Houston, Texas.
²⁷ Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.
²⁸ Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia.
²⁹ Translational Research Institute, Brisbane, Australia.
³⁰ Clinic of Pediatrics, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
³¹ Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.
³² Department of Nephrology, Sunshine Coast University Hospital, Birtinya, Australia.
³³ Faculty of Medicine, University of Queensland, Herston, Australia.
³⁴ University Francois Rabelais, Tours, France.
³⁵ Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France.
³⁶ College of Medicine and Public Health, Flinders University, Adelaide, Australia.

PMID: 34969698
PMCID: PMC8763157
DOI: 10.2215/CJN.07840621

Abstract

Background and objectives: Outcomes reported in trials in adults with glomerular disease are often selected with minimal patient input, are heterogeneous, and may not be relevant for clinical decision making. The Standardized Outcomes in Nephrology-Glomerular Disease (SONG-GD) initiative aimed to establish a core outcome set to help ensure that outcomes of critical importance to patients, care partners, and clinicians are consistently reported.

Design, setting, participants, and measurements: We convened two 1.5-hour workshops in Melbourne, Australia, and Washington, DC, United States. Attendees were identified purposively with 50 patients/care partners and 88 health professionals from 19 countries; 51% were female. Patients and care partners were from the United States, Australia, and Canada, and had experience of a glomerular disease with systemic features (n=9), kidney-limited nephrotic disease (n=9), or other kidney-limited glomerular disease (n=8). Attendees reviewed the results of the SONG-GD Delphi survey and aims of the workshop and then discussed potential core outcomes and their implementation in trials among moderated breakout groups of eight to 12 people from diverse backgrounds. Transcripts of discussions were analyzed thematically.

Results: Three themes were identified that supported the proposed core outcomes: limiting disease progression, stability and control, and ensuring universal relevance (i.e., applicable across diverse populations and settings). The fourth theme, preparedness for implementation, included engaging with funders and regulators, establishing reliable and validated measures, and leveraging existing endorsements for patient-reported outcomes.

Conclusions: Workshop themes demonstrated support for kidney function, disease activity, death, life participation, and cardiovascular disease, and these were established as the core outcomes for trials in adults with glomerular disease. Future work is needed to establish the core measures for each domain, with funders and regulators central to the uptake of the core outcome set in trials.

Keywords: cardiovascular disease; epidemiology and outcomes; glomerular disease; glomerulonephritis; mortality; nephrotic syndrome; outcomes; quality of life; randomized controlled trials.

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Figures

**Figure 1.**
**The Standardized Outcomes in Nephrology–Glomerular Disease (SONG-GD) core outcome set to be reported in all trials in adults with glomerular disease**.

See this image and copyright information in PMC

Comment in

Trial Outcomes in Glomerular Diseases.
Troost JP. Troost JP. Clin J Am Soc Nephrol. 2022 Jan;17(1):11-13. doi: 10.2215/CJN.15001121. Epub 2021 Dec 30. Clin J Am Soc Nephrol. 2022. PMID: 34969700 Free PMC article. No abstract available.

References

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A Core Outcome Set for Trials in Glomerular Disease: A Report of the Standardized Outcomes in Nephrology-Glomerular Disease (SONG-GD) Stakeholder Workshops

Affiliations

A Core Outcome Set for Trials in Glomerular Disease: A Report of the Standardized Outcomes in Nephrology-Glomerular Disease (SONG-GD) Stakeholder Workshops

Authors

Affiliations

Abstract

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Medical