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 (n59), kidney-limited nephrotic disease (n59), or other kidney-limited glomerular disease (n58). 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 53-64 |
| Number of pages | 12 |
| Journal | Clinical Journal of the American Society of Nephrology |
| Volume | 17 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 2022 |
ASJC Scopus subject areas
- Epidemiology
- Critical Care and Intensive Care Medicine
- Nephrology
- Transplantation
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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. / Carter, Simon A.; Lightstone, Liz; Cattran, Dan et al.
In: Clinical Journal of the American Society of Nephrology, Vol. 17, No. 1, 01.2022, p. 53-64.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - A Core Outcome Set for Trials in Glomerular Disease A Report of the Standardized Outcomes in Nephrology–Glomerular Disease (SONG-GD) Stakeholder Workshops
AU - Carter, Simon A.
AU - Lightstone, Liz
AU - Cattran, Dan
AU - Tong, Allison
AU - Bagga, Arvind
AU - Barbour, Sean J.
AU - Barratt, Jonathan
AU - Boletis, John
AU - Caster, Dawn J.
AU - Coppo, Rosanna
AU - Fervenza, Fernando C.
AU - Floege, J€Urgen
AU - Hladunewich, Michelle A.
AU - Hogan, Jonathan J.
AU - Kitching, A. Richard
AU - Lafayette, Richard A.
AU - Malvar, Ana
AU - Radhakrishnan, Jai
AU - Rovin, Brad H.
AU - Scholes-Robertson, Nicole
AU - Trimarchi, Hernán
AU - Zhang, Hong
AU - Anumudu, Samaya
AU - Cho, Yeoungjee
AU - Gutman, Talia
AU - O’lone, Emma
AU - Viecelli, Andrea K.
AU - Au, Eric
AU - Azukaitis, Karolis
AU - Baumgart, Amanda
AU - Bernier-Jean, Amelie
AU - Dunn, Louese
AU - Howell, Martin
AU - Ju, Angela
AU - Logeman, Charlotte
AU - Nataatmadja, Melissa
AU - Sautenet, Benedicte
AU - Sharma, Ankit
AU - Craig, Jonathan C.
N1 - Funding Information: S. Anumudu reports serving as an ASN Public Policy Committee member and a Renal Physicians Association board member, Government Affairs Committee vice chair, and Membership and Education Committee member and receiving honoraria from KDIGO Controversies Conference on BP and volume management in dialysis (travel expenses reimbursed) and from St. George’s University (occasional honoraria for helping with student events or webinars as student counselor and alumni admissions mentor program). E. Au reports serving as a member of Australia and New Zealand Society of Nephrology, ISN, The Transplantation Society, and Transplantation Society of Australia and New Zealand; serving as a scientific advisor or member of Kidney360 and Transplantation; and having ownership interest in Medibank Australia. A. Bagga reports having consultancy agreements from Novartis for serving on a steering committee on hemolytic uremic syndrome. S.J. Barbour reports having consultancy agreements with Achillion, Alexion, Inception Sciences, Novartis, and Visterra; receiving research funding from Alexion and Roche; and receiving honoraria from Alexion and Roche. J. Barratt reports having consultancy agreements with Alnylam, Astellas, BioCryst, Calliditas, Chinook, Dimerix, Novartis, Omeros, Travere Therapeutics, Vera Therapeutics, and Visterra; receiving research funding from Argenx, Calliditas, Chinook, Galapagos, GlaxoSmithKline (GSK), Novartis, Omeros, Travere Therapeutics, and Visterra; and serving as on the editorial boards of CJASN, Clinical Science, Glomerular Diseases, and Kidney International. I. Boletis reports serving on the editorial boards for International Clinical Case Journal and Transplantation Proceedings. S.A. Carter reports having ownership interest in Commonwealth Serum Laboratories Limited. D.J. Caster reports having consultancy agreements with, and receiving honoraria from, Aurinia, Calliditas, Chinook, GSK, and Travere (previously Retrophin); serving on speakers bureaus for Aurinia and GSK; serving on the editorial board for Glomerular Diseases, and as a scientific advisor or member of Lupus Foundation of America Medical Scientific Advisory Counsel; and having other interests/ relationships with NIH via grants K08 1K08DK102542 and R01 1RO1DK126777. D. Cattran reports receiving research funding from Alnylam; having consultancy agreements with Alnylam, Cal-liditis, Chemocentryx, Principia, and Reistone; receiving honoraria from Calliditis, Kyowa Hakko Kirin Co., and Principia; having other interests/relationships with Chemocentryx and Novartis; and serving as a scientific advisor or member of Kidney International, NephCure, SONG-GD, and UpToDate. Y. Cho reports receiving research funding from Baxter Healthcare and Fresenius Medical Care; receiving honoraria from Baxter Healthcare, Fresenius Medical Care, and Genzyme; and serving as clinical trialist and chair of the Australasian Kidney Trials Network Peritoneal Dialysis Working Group, and as a member of the coordinating committee for SONG. R. Coppo reports having consultancy agreements with Amgen, Argenx, Calliditas, Novartis, Reata, and Travere; receiving honoraria from Amgen, Argenx, Calliditas, Novartis, and Travere; being employed by Fondazione Ricerca Molinette; serving as a scientific advisor or member of the ISN Council and on the editorial board for Nephrology Dialysis Transplantation; and serving as an associate editor of Pediatric Nephrology. J.C. Craig reports serving on the editorial boards of Clinical Epidemiology and Diagnostic and Prognostic Research, as coordinating editor of Cochrane Kidney and Transplant, and as vice president of Flinders University. F.C. Fervenza reports having consultancy agreements with Alexion Pharmaceuticals, Alnylam, ByoCrystal, Novartis, and Takeda; receiving research funding from Chemocen-tryx, Genentech, Janssen Pharmaceutical, Questcor/Mallinckrodt, and Retrophin; serving as a scientific advisor or member of JASN, Kidney International, Nephrology, Nephrology Dialysis and Transplantation, and UpToDate; being employed by Mayo Clinic; and receiving honoraria from UpToDate. J. Floege reports receiving honoraria from Amgen, Astellas, Bayer, Calliditas, Novo Nordisk, Omeros, Travere, Vifor, and Visterra; having consultancy agreements with Amgen, Bayer, Calliditas, Novo Nordisk, Omeros, Tra-vere, Vifor, and Visterra; serving on speakers bureaus for Amgen and Vifor; and serving as a scientific advisor or member of Callidi-tas, Omeros, and Travere. T. Gutman reports serving on the Patient-centered Research Network coordinating committee and Funding Information: S.A. Carter is supported by the NHMRC Postgraduate Scholarship number 1168994. D. J. Caster is supported by NIH grant K08DK102542. Y. Cho is supported by the NHMRC Early Career Fellowship number 1126256. T. Gutman is supported by a NHMRC Postgraduate Scholarship number 1169149. N. Scholes-Robertson is supported by a NHMRC Postgraduate Scholarship number 1190850. A.K. Viecelli received support from the NHMRC Medical Postgraduate Scholarship number 1114539 and a Royal Australasian College of Physicians Jacquot Research Establishment Fellowship. Funding Information: on the SONG initiative coordinating committee (no financial relationships). M.A. Hladunewich reports having consultancy agreements with Alnylam Pharmaceuticals; receiving research funding from Calliditas Therapeutics, Chemocentryx, Ionis, Pfizer, and Roche; having other interests/relationships with Glomerular Disease Ontario Renal Network as medical lead; and serving as a scientific advisor or member of Kidney International and UpToDate. J.J. Hogan reports receiving research funding from Achillion (as site principal investigator [PI] for clinical trial in C3 glomerulop-athy), Boeringer Ingelheim (for Transformative Research in Diabetic Nephropathy [TRIDENT] study for diabetic nephropathy), Calliditas (as site PI for clinical trial in IgA nephropathy), Com-plexa (as site PI for clinical trial in FSGS), Gilead, GSK, NIH (for study in membranous nephropathy and as site PI for the Belimu-mab With Rituximab for Primary Membranous Nephropathy [REBOOT] study in membranous nephropathy), Omeros (as site PI for clinical trial in IgA nephropathy), Regeneron, and Retrophin (as site PI for the Efficacy and Safety of Sparsentan [RE-021], a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients with Focal Segmental Glomerulosclerosis [FSGS]: A Randomized, Double-blind, Active-Control, Dose-Escalation Study [DUET] and a Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS [DUPLEX] Studies in FSGS); having consultancy agreements with, and receiving honoraria from, Alexion, Aurinia, Calliditas, GSK, Kaneka, Kezar, and Tra-vere; being employed by Janssen: Pharmaceutical Companies of Johnson and Johnson; and receiving royalties for patent (pending) as coinventor (WO2019213434A1) and author royalties from UpTo-Date.com for topics on calcium/phosphate balance and monoclonal gammopathies of renal significance. A.R. Kitching reports serving as a scientific advisor or member of Australian and New Zealand Vasculitis Society; receiving research funding from CSL Limited and Vifor Pharma; having other interests/relationships as a member of the Kidney Health Australia Research Advisory Group; having consultancy agreements with Toleranzia and Vis-terra; and receiving honoraria from Visterra. R.A. Lafayette reports having consultancy agreements with Alexion Inc., Aurinia, Callidi-tas Inc., Chinook Inc., Novartis, Omeros Inc., Otsuka Inc., Travere Inc., Vera Inc., and Visterra Inc.; and receiving research funding from Apellis, Calliditas, Chemocentryx, Chinook, NIH, Omeros, Otsuka, Pfizer, Roche, Travere, and Vera. L. Lightstone reports having consultancy agreements with Achillion, AstraZeneca, Bristol Myers Squibb (BMS), GSK, Pfizer, and Roche; receiving honoraria from Alexion, AstraZeneca, BMS, GSK, and Pfizer; serving on speakers bureaus for Alexion and GSK; having other interests/ relationships as executive committee member of ISN (2021–2023), deputy chair of the Western Regional Board of ISN, trustee of Kidney Research UK (2018–2022), and clinical expert representing the Renal Association’s response to the National Institute for Health and Care Excellence on single technology appraisal for belimumab in lupus (2020–2021); and serving as a scientific advisor or member of the European Union Executive Committee of the Lupus Nephritis Trials Network and Nature Reviews Nephrology Advisory Board. M. Nataatmadja reports previously receiving travel support from Amgen. J. Radhakrishnan reports receiving honoraria from Angion Biomedica, Aurinia Pharmaceuticals, Equillium Bio, GSK, Reata Pharmaceuticals, Reistone Biopharma, Sanofi Genzyme, and Tra-vere Therapeutics; having consultancy agreements with Angion Biomedica, Aurinia Pharmaceuticals, Equillium Bio, Reata Pharmaceuticals, Reistone Biopharma, Sanofi Genzyme, and Travere Therapeutics; receiving research funding from Bayer and Travere Therapeutics; and serving as a scientific advisor or member of Kidney International and Kidney International Reports. B.H. Rovin reports having consultancy agreements with Alexion, AstraZeneca, Aurinia, Biogen, BMS, Calliditas, Chemocentryx, EMD-Serono/ Merck, Genentech, Human Genome Sciences (GSK), Idorsia, Janssen, MedImmune, Morphosys, Novartis, Omeros, Retrophin, RILITE Foundation, Roche, and Vistera; receiving honoraria from Alexion, AstraZeneca, Aurinia, Biogen, BMS, Calliditas, Che-mocentryx, EMD-Serono/Merck, Genentech, Human Genome Sciences (GSK), Idorsia, Janssen, Morphosys, Novartis, Omeros, Ret-rophin, RILITE Foundation, Roche, and Vistera; performing other work with ASN (mostly educational courses), ISN and National Kidney Foundation, and the Lupus Foundation of America; and serving as a scientific advisor or member of ASN Kidney Week, CureGN, KDIGO, Kidney International, Kidney International Reports, Lupus Foundation of America, Nephrology Dialysis and Transplantation, and UpToDate. N. Scholes-Robertson reports having other interests/relationships with the consumer advisory board of BEAT-CKD (Australia) and Rural Kidney Association Inc. (NSW, Australia); serving as a patient editor of Cochrane Kidney and Transplant; and serving as a scientific advisor or member of Rural Kidney Association Inc. (NSW, Australia). H. Trimarchi reports serving as a scientific advisor or member of American College of Physicians, Argentinian Society of Nephrology, ASN, and ISN and having consultancy agreements with, and receiving honoraria from, Calliditas, Chinook, Novartis, Sanofi Genzyme, Travere, and Visterra-Otsuka. H. Zhang reports serving as vice-director of the nephrology committee of the Beijing Society of Medicine, as a board committee member of nephrology of the Chinese Medical Doctor Association and the Chinese Society of Nephrology, on the member of ISN–Advancing Clinical Trials Committee, and as a member of ISN Global Outreach - Sister Renal Centres Committee and having consultancy agreements with Calliditas, Janssen, Novartis, and Omeros. All remaining authors have nothing to disclose. Publisher Copyright: © 2022 by the American Society of Nephrology.
PY - 2022/1
Y1 - 2022/1
N2 - 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 (n59), kidney-limited nephrotic disease (n59), or other kidney-limited glomerular disease (n58). 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.
AB - 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 (n59), kidney-limited nephrotic disease (n59), or other kidney-limited glomerular disease (n58). 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.
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UR - http://www.scopus.com/inward/citedby.url?scp=85123313868&partnerID=8YFLogxK
U2 - 10.2215/CJN.07840621
DO - 10.2215/CJN.07840621
M3 - Article
C2 - 34969698
AN - SCOPUS:85123313868
VL - 17
SP - 53
EP - 64
JO - Clinical Journal of the American Society of Nephrology
JF - Clinical Journal of the American Society of Nephrology
SN - 1555-9041
IS - 1
ER -