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

Clinical Trials as Topic Congresses as Topic Female Humans Kidney Diseases / therapy Kidney Glomerulus Male Outcome Assessment, Health Care
cardiovascular disease epidemiology and outcomes glomerular disease glomerulonephritis mortality nephrotic syndrome outcomes quality of life randomized controlled trials

Journal

Clinical journal of the American Society of Nephrology : CJASN
ISSN: 1555-905X
Titre abrégé: Clin J Am Soc Nephrol
Pays: United States
ID NLM: 101271570

Informations de publication

Date de publication:
01 2022
Historique:
received: 06 06 2021
accepted: 01 11 2021
pubmed: 1 1 2022
medline: 18 3 2022
entrez: 31 12 2021
Statut: ppublish

Résumé

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. 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 ( Three themes were identified that supported the proposed core outcomes: limiting disease progression, stability and control, and ensuring universal relevance ( 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.

Sections du résumé

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 (
RESULTS
Three themes were identified that supported the proposed core outcomes: limiting disease progression, stability and control, and ensuring universal relevance (
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.

Identifiants

DOI: 10.2215/CJN.07840621 PMID: 34969698 PMC: PMC8763157
pubmed: 34969698
pii: 01277230-202201000-00010
doi: 10.2215/CJN.07840621
pmc: PMC8763157
doi:

Types de publication

Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

53-64

Subventions

Organisme : NIDDK NIH HHS
ID : K08 DK102542
Pays : United States
Organisme : NIDDK NIH HHS
ID : R01 DK126777
Pays : United States

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2022 by the American Society of Nephrology.

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Auteurs

Simon A Carter (SA)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.
ORCID: 0000-0001-7884-7015

Liz Lightstone (L)

Centre for Inflammatory Disease, Faculty of Medicine, Imperial College London, London, United Kingdom.

Dan Cattran (D)

Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
Toronto General Research Institute, Toronto, Ontario, Canada.

Allison Tong (A)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.

Arvind Bagga (A)

All India Institute of Medical Sciences, Department of Pediatrics, New Delhi, India.

Sean J Barbour (SJ)

Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, Canada.

Jonathan Barratt (J)

Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.
John Walls Renal Unit, Leicester General Hospital, Leicester, United Kingdom.
ORCID: 0000-0002-9063-7229

John Boletis (J)

Department of Nephrology and Renal Transplantation, Medical School, University of Athens, Laiko Hospital, Athens, Greece.

Dawn J Caster (DJ)

Division of Nephrology, University of Louisville, Louisville, Kentucky.

Rosanna Coppo (R)

Molinette Research Foundation, Regina Margherita Hospital, Turin, Italy.

Fernando C Fervenza (FC)

Division of Nephrology and Hypertension, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.
ORCID: 0000-0002-9952-209

Jürgen Floege (J)

Department of Nephrology and Clinical Immunology, RWTH University Hospital, Aachen, Germany.

Michelle A Hladunewich (MA)

Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.

Jonathan J Hogan (JJ)

Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.

A Richard Kitching (AR)

Departments of Nephrology and Paediatric Nephrology, Monash Health, Clayton, Victoria, Australia.
Centre for Inflammatory Diseases, Department of Medicine, Monash University, Clayton, Victoria, Australia.
ORCID: 0000-0002-2713-2391

Richard A Lafayette (RA)

Stanford University Medical Center, Stanford, California.
Division of Nephrology, Department of Medicine, Stanford University, Stanford, California.

Ana Malvar (A)

Nephrology, Hospital Fernández, Buenos Aires, Argentina.

Jai Radhakrishnan (J)

Columbia University Medical Center, New York, New York.

Brad H Rovin (BH)

Division of Nephrology, Department of Internal Medicine, Ohio State University Wexner Medical Center, Columbus, Ohio.

Nicole Scholes-Robertson (N)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.
ORCID: 0000-0001-8260-0453

Hernán Trimarchi (H)

Nephrology Service and Kidney Transplantation Unit, Hospital Britanico de Buenos Aires, Buenos Aires, Argentina.

Hong Zhang (H)

Renal Division of Peking University First Hospital, Beijing, China.

Samaya Anumudu (S)

Department of Nephrology, Baylor College of Medicine, Houston, Texas.

Yeoungjee Cho (Y)

Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.
Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia.
Translational Research Institute, Brisbane, Australia.

Talia Gutman (T)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.
ORCID: 0000-0002-6341-8725

Emma O'Lone (E)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.

Andrea K Viecelli (AK)

Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.
Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia.

Eric Au (E)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.
ORCID: 0000-0002-6089-5913

Karolis Azukaitis (K)

Clinic of Pediatrics, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.

Amanda Baumgart (A)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.

Amelie Bernier-Jean (A)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.

Louese Dunn (L)

Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.

Martin Howell (M)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.
ORCID: 0000-0001-9740-712

Angela Ju (A)

Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.

Charlotte Logeman (C)

Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.

Melissa Nataatmadja (M)

Department of Nephrology, Sunshine Coast University Hospital, Birtinya, Australia.
Faculty of Medicine, University of Queensland, Herston, Australia.
ORCID: 0000-0001-5776-6160

Benedicte Sautenet (B)

University Francois Rabelais, Tours, France.
Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France.

Ankit Sharma (A)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia.

Jonathan C Craig (JC)

College of Medicine and Public Health, Flinders University, Adelaide, Australia.

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