Simon A Carter1,2, Liz Lightstone3, Dan Cattran4,5, Allison Tong6,2, Arvind Bagga7, Sean J Barbour8, Jonathan Barratt9,10, John Boletis11, Dawn J Caster12, Rosanna Coppo13, Fernando C Fervenza14, Jürgen Floege15, Michelle A Hladunewich4,16, Jonathan J Hogan17, A Richard Kitching18,19, Richard A Lafayette20,21, Ana Malvar22, Jai Radhakrishnan23, Brad H Rovin24, Nicole Scholes-Robertson6,2, Hernán Trimarchi25, Hong Zhang26, Samaya Anumudu27, Yeoungjee Cho28,29,30, Talia Gutman6,2, Emma O'Lone6, Andrea K Viecelli28,29, Eric Au6,2, Karolis Azukaitis31, Amanda Baumgart6,2, Amelie Bernier-Jean6,2, Louese Dunn32, Martin Howell6,2, Angela Ju2, Charlotte Logeman2, Melissa Nataatmadja33,34, Benedicte Sautenet35,36, Ankit Sharma6,2, Jonathan C Craig. 1. Sydney School of Public Health, The University of Sydney, Sydney, Australia simon.carter@health.nsw.gov.au. 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. Sydney School of Public Health, The University of Sydney, Sydney, Australia. 7. All India Institute of Medical Sciences, Department of Pediatrics, New Delhi, India. 8. Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, Canada. 9. Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom. 10. John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom. 11. Department of Nephrology and Renal Transplantation, Medical School, University of Athens, Laiko Hospital, Athens, Greece. 12. Division of Nephrology, University of Louisville, Louisville, Kentucky. 13. Molinette Research Foundation, Regina Margherita Hospital, Turin, Italy. 14. Division of Nephrology and Hypertension, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota. 15. Department of Nephrology and Clinical Immunology, RWTH University Hospital, Aachen, Germany. 16. Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. 17. Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 18. Departments of Nephrology and Paediatric Nephrology, Monash Health, Clayton, Victoria, Australia. 19. Centre for Inflammatory Diseases, Department of Medicine, Monash University, Clayton, Victoria, Australia. 20. Stanford University Medical Center, Stanford, California. 21. Division of Nephrology, Department of Medicine, Stanford University, Stanford, California. 22. Nephrology, Hospital Fernández, Buenos Aires, Argentina. 23. Columbia University Medical Center, New York, New York. 24. Division of Nephrology, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio. 25. Nephrology Service and Kidney Transplantation Unit, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina. 26. Renal Division of Peking University First Hospital, Beijing, China. 27. Department of Nephrology, Baylor College of Medicine, Houston, Texas. 28. Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia. 29. Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia. 30. Translational Research Institute, Brisbane, Australia. 31. Clinic of Pediatrics, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania. 32. Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom. 33. Department of Nephrology, Sunshine Coast University Hospital, Birtinya, Australia. 34. Faculty of Medicine, University of Queensland, Herston, Australia. 35. University Francois Rabelais, Tours, France. 36. Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France.
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.
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.
Authors: Allison Tong; John Gill; Klemens Budde; Lorna Marson; Peter P Reese; David Rosenbloom; Lionel Rostaing; Germaine Wong; Michelle A Josephson; Timothy L Pruett; Anthony N Warrens; Jonathan C Craig; Benedicte Sautenet; Nicole Evangelidis; Angelique F Ralph; Camilla S Hanson; Jenny I Shen; Kirsten Howard; Klemens Meyer; Ronald D Perrone; Daniel E Weiner; Samuel Fung; Maggie K M Ma; Caren Rose; Jessica Ryan; Ling-Xin Chen; Martin Howell; Nicholas Larkins; Siah Kim; Sobhana Thangaraju; Angela Ju; Jeremy R Chapman Journal: Transplantation Date: 2017-08 Impact factor: 4.939
Authors: Allison Tong; Braden Manns; Brenda Hemmelgarn; David C Wheeler; Nicole Evangelidis; Peter Tugwell; Sally Crowe; Wim Van Biesen; Wolfgang C Winkelmayer; Donal O'Donoghue; Helen Tam-Tham; Jenny I Shen; Jule Pinter; Nicholas Larkins; Sajeda Youssouf; Sreedhar Mandayam; Angela Ju; Jonathan C Craig Journal: Am J Kidney Dis Date: 2016-08-03 Impact factor: 8.860
Authors: Bénédicte Sautenet; Allison Tong; Gabrielle Williams; Brenda R Hemmelgarn; Braden Manns; David C Wheeler; Peter Tugwell; Wim van Biesen; Wolfgang C Winkelmayer; Sally Crowe; Tess Harris; Nicole Evangelidis; Carmel M Hawley; Carol Pollock; David W Johnson; Kevan R Polkinghorne; Kirsten Howard; Martin P Gallagher; Peter G Kerr; Stephen P McDonald; Angela Ju; Jonathan C Craig Journal: Am J Kidney Dis Date: 2018-02-21 Impact factor: 8.860
Authors: Martin Howell; Germaine Wong; Robin M Turner; Ho Teck Tan; Allison Tong; Jonathan C Craig; Kirsten Howard Journal: Am J Kidney Dis Date: 2015-12-24 Impact factor: 8.860
Authors: John J Sim; Simran K Bhandari; Michael Batech; Aviv Hever; Teresa N Harrison; Yu-Hsiang Shu; Dean A Kujubu; Tracy Y Jonelis; Michael H Kanter; Steven J Jacobsen Journal: Mayo Clin Proc Date: 2018-01-24 Impact factor: 7.616
Authors: Simon A Carter; Charlotte Logeman; Martin Howell; Dan Cattran; Liz Lightstone; Arvind Bagga; Sean J Barbour; Jonathan Barratt; John Boletis; Dawn J Caster; Rosanna Coppo; Fernando C Fervenza; Jürgen Floege; Michelle A Hladunewich; Jonathan J Hogan; A Richard Kitching; Richard A Lafayette; Ana Malvar; Jai Radhakrishnan; Brad H Rovin; Nicole Scholes-Robertson; Hérnan Trimarchi; Hong Zhang; Yeoungjee Cho; Louese Dunn; Debbie S Gipson; Adrian Liew; Benedicte Sautenet; Andrea K Viecelli; David Harris; David W Johnson; Angela Yee-Moon Wang; Armando Teixeira-Pinto; Stephen I Alexander; Adam Martin; Allison Tong; Jonathan C Craig Journal: Kidney Int Date: 2021-05-05 Impact factor: 18.998
Authors: Karine E Manera; David W Johnson; Jonathan C Craig; Jenny I Shen; Talia Gutman; Yeoungjee Cho; Angela Yee-Moon Wang; Edwina A Brown; Gillian Brunier; Jie Dong; Tony Dunning; Rajnish Mehrotra; Saraladevi Naicker; Roberto Pecoits-Filho; Jeffrey Perl; Martin Wilkie; Allison Tong Journal: Am J Kidney Dis Date: 2020-01-16 Impact factor: 8.860