1. Establishing a peritoneal dialysis technique survival core outcome measure: A standardised outcomes in nephrology-peritoneal dialysis consensus workshop report.
- Author
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Elphick EH, Manera KE, Viecelli AK, Craig JC, Cho Y, Ju A, Shen JI, Wilkie M, Anumudu S, Boudville N, Chow JS, Davies SJ, Gooden P, Harris T, Jain AK, Liew A, Matus-Gonzalez A, Amir N, Nadeau-Fredette AC, Nguyen T, Wang AY, Ponce D, Quinn R, Jaure A, Johnson DW, and Lambie M
- Abstract
Background: Technique survival, also reported with negative connotations as technique failure or transfer from peritoneal dialysis to haemodialysis, has been identified by patients, caregivers and health professionals as a critically important outcome to be reported in all trials. However, there is wide variation in how peritoneal dialysis technique survival is defined, measured and reported, leading to difficulty in comparing or consolidating results., Methods: We conducted an online international consensus workshop to establish a core outcome measure of technique survival. Discussions were analysed thematically., Results: Fifty-five participants including 14 patients and caregivers from 13 countries took part in facilitated breakout discussions using video-conferencing. The following themes were identified: capturing important aspects of the outcome (requiring a core event to define the outcome, distinguishing temporary from permanent events, recognising heterogeneous experiences of transfers), adopting appropriate neutral nomenclature (conveying with clarity, avoiding negative connotations), and ensuring feasibility and applicability (capturing data relevant to clinical and research settings, ease of adoption). The suggested definitions for the core outcome measure were 'the event of a transfer to haemodialysis', or 'discontinuation of peritoneal dialysis'. Applying the principles described within the workshop, defining the outcome measure as a 'transfer to haemodialysis' was preferable., Conclusions: It is proposed that the core outcome of technique survival is redefined as 'transfer to haemodialysis' and that its components are standardised using simple, neutral terminology Components considered important by stakeholders included recording the reasons for transfer from peritoneal dialysis, and focussing on permanent events whilst ensuring the outcome remains easy to implement., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: ML and SD have received speaker's honoraria from Baxter Healthcare and Fresenius Medical Care, and an unrestricted research grant from Baxter Healthcare. JSFC has received speaker's honoraria and research funds from Baxter Healthcare, Fresenius Medical Care, Roche Pharmaceuticals and Amgen. NB has received speaking honoraria from Baxter Healthcare and Otsuka and is on the Advisory Board for Astra Zeneca, Fresenius Medical Care, Vifor, and GSK. DWJ has received consultancy fees, research grants, speaker's honoraria and travel sponsorships from Baxter Healthcare and Fresenius Medical Care, consultancy fees from Astra Zeneca, Bayer, and AWAK, speaker's honoraria from ONO and Boehringer Ingelheim & Lilly, and travel sponsorships from Ono and Amgen. He is a current recipient of an Australian National Health and Medical Research Council (NHMRC) Leadership Investigator Grant. AL has served as a consultant and member of advisory boards for Alnylam Pharmaceuticals, AstraZeneca, Baxter Healthcare, Bayer AG, Boehringer-Ingelheim, Chinook Therapeutics, Dimerix Limited, Eledon Pharmaceuticals, George Clinical, GlaxoSmithKline, Kira Pharmaceuticals, Prokidney, Otsuka Pharmaceuticals and Visterra Inc, Zai Lab Co. Ltd; has received Speaker's honorarium from AstraZeneca, Baxter Healthcare, Boehringer-Ingelheim, Chinook Therapeutics and Otsuka Pharmaceuticals; and has served as a member of Data Safety and Monitoring Committee for Dimerix Limited and Zai Lab Co. Ltd. AKJ has received research and education grants from Baxter Healthcare, Otsuka Pharmaceuticals and serves as an advisory board member for AWAK Technologies. JIS has served as a consultant and member of advisory boards for Healthmap Solutions and Dialco Medical, grants from the Canadian Institutes of Health Research, and speaker's honorarium from Outset Medical. AKV receives grant support from a Queensland Advancing Clinical Research Fellowship and an NHMRC Emerging Leader Grant. MW has received speakers honoraria from Baxter Healthcare and Fresenius Medical Care, consulting fees from Triomed AB, and an unrestricted research grant from Baxter Healthcare. RQ is the co-inventor of the Dialysis Information Management System™, Canada, and is the co-owner of the intellectual property associated with it, and has received honoraria and attended advisory boards for Baxter Healthcare. YC is a current recipient of the Australian NHMRC Emerging Leadership Investigator Grant (2022–2026) and Queensland Advancing Clinical Fellowship (2022–2025; mid-career). She has received honoraria and research grants from Baxter Healthcare and Fresenius Medical Care, and a consultancy fee from Bupa Health Insurance. ACNF has received honoraria for presentations from Baxter Healthcare and a Scholarship from Fond de Recherche du Québec – Santé. NA is supported by an NHMRC Postgraduate Scholarship. SQ is on the board of the Renal Physician's Association (unpaid) and a medical director at the Davita home dialysis unit. PG, KEM, TH, both AJ's, AMG, DP, AYW, JCC and EE have no disclosures.
- Published
- 2024
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