Literature DB >> 31200941

An international Delphi survey helped develop consensus-based core outcome domains for trials in peritoneal dialysis.

Karine E Manera1, Allison Tong2, Jonathan C Craig3, Jenny Shen4, Shilpa Jesudason5, Yeoungjee Cho6, Benedicte Sautenet7, Armando Teixeira-Pinto2, Martin Howell2, Angela Yee-Moon Wang8, Edwina A Brown9, Gillian Brunier10, Jeffrey Perl11, Jie Dong12, Martin Wilkie13, Rajnish Mehrotra14, Roberto Pecoits-Filho15, Saraladevi Naicker16, Tony Dunning17, Nicole Scholes-Robertson18, David W Johnson19.   

Abstract

Shared decision-making about clinical care options in end-stage kidney disease is limited by inconsistencies in the reporting of outcomes and the omission of patient-important outcomes in trials. Here we generated a consensus-based prioritized list of outcomes to be reported during trials in peritoneal dialysis (PD). In an international, online, three-round Delphi survey, patients/caregivers and health professionals rated the importance of outcomes using a 9-point Likert scale (with 7-9 indicating critical importance) and provided comments. Using a Best-Worst Scale (BWS), the relative importance of outcomes was estimated. Comments were analyzed thematically. In total, 873 participants (207 patients/caregivers and 666 health professionals) from 68 countries completed round one, 629 completed round two and 530 completed round three. The top outcomes were PD-related infection, membrane function, peritoneal dialysis failure, cardiovascular disease, death, catheter complications, and the ability to do usual activities. Compared with health professionals, patients/caregivers gave higher priority to six outcomes: blood pressure (mean difference, 0.4), fatigue (0.3), membrane function (0.3), impact on family/friends (0.1), peritoneal thickening (0.1) and usual activities (0.1). Four themes were identified that underpinned the reasons for ratings: contributing to treatment longevity, preserving quality of life, escalating morbidity, and irrelevant and futile information and treatment. Patients/caregivers and health professionals gave highest priority to clinical outcomes. In contrast to health professionals, patients/caregivers gave higher priority to lifestyle-related outcomes including the impact on family/friends and usual activities. Thus, prioritization will inform a core outcome set to improve the consistency and relevance of outcomes for trials in PD.
Copyright © 2019 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  core outcome sets; kidney disease; outcomes; patient-centered care; peritoneal dialysis; trials

Mesh:

Year:  2019        PMID: 31200941      PMCID: PMC6961705          DOI: 10.1016/j.kint.2019.03.015

Source DB:  PubMed          Journal:  Kidney Int        ISSN: 0085-2538            Impact factor:   10.612


  38 in total

1.  Nephrologists' Perspectives on Defining and Applying Patient-Centered Outcomes in Hemodialysis.

Authors:  Allison Tong; Wolfgang C Winkelmayer; David C Wheeler; Wim van Biesen; Peter Tugwell; Braden Manns; Brenda Hemmelgarn; Tess Harris; Sally Crowe; Angela Ju; Emma O'Lone; Nicole Evangelidis; Jonathan C Craig
Journal:  Clin J Am Soc Nephrol       Date:  2017-02-21       Impact factor: 8.237

Review 2.  Biomarker research to improve clinical outcomes of peritoneal dialysis: consensus of the European Training and Research in Peritoneal Dialysis (EuTRiPD) network.

Authors:  Christoph Aufricht; Robert Beelen; Matthias Eberl; Michel Fischbach; Donald Fraser; Achim Jörres; Klaus Kratochwill; Manuel LópezCabrera; Peter Rutherford; Claus-Peter Schmitt; Nicholas Topley; Janusz Witowski
Journal:  Kidney Int       Date:  2017-08-08       Impact factor: 10.612

3.  Icodextrin improves the fluid status of peritoneal dialysis patients: results of a double-blind randomized controlled trial.

Authors:  Simon J Davies; Graham Woodrow; Kieron Donovan; Jörg Plum; Paul Williams; Ann Catherine Johansson; Hans-Peter Bosselmann; Olof Heimbürger; Ole Simonsen; Andrew Davenport; Anders Tranaeus; Jose C Divino Filho
Journal:  J Am Soc Nephrol       Date:  2003-09       Impact factor: 10.121

Review 4.  Fatigue in patients receiving maintenance dialysis: a review of definitions, measures, and contributing factors.

Authors:  Manisha Jhamb; Steven D Weisbord; Jennifer L Steel; Mark Unruh
Journal:  Am J Kidney Dis       Date:  2008-06-24       Impact factor: 8.860

5.  The Euro-Balance Trial: the effect of a new biocompatible peritoneal dialysis fluid (balance) on the peritoneal membrane.

Authors:  John D Williams; Nicholas Topley; Kathrine J Craig; Ruth K Mackenzie; Monika Pischetsrieder; Cristina Lage; Jutta Passlick-Deetjen
Journal:  Kidney Int       Date:  2004-07       Impact factor: 10.612

6.  Prospective controlled trial of a Y-connector and disinfectant to prevent peritonitis in continuous ambulatory peritoneal dialysis.

Authors:  R Maiorca; A Cantaluppi; G C Cancarini; A Scalamogna; R Broccoli; G Graziani; S Brasa; C Ponticelli
Journal:  Lancet       Date:  1983-09-17       Impact factor: 79.321

7.  Duration of Hemodialysis Following Peritoneal Dialysis Cessation in Australia and New Zealand: Proposal for a Standardized Definition of Technique Failure.

Authors:  Patrick G Lan; Philip A Clayton; David W Johnson; Stephen P McDonald; Monique Borlace; Sunil V Badve; Kamal Sud; Neil Boudville
Journal:  Perit Dial Int       Date:  2016-05-04       Impact factor: 1.756

8.  Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease-Improving Global Outcomes (KDIGO) Controversies Conference.

Authors:  Colin Baigent; William G Herrington; Josef Coresh; Martin J Landray; Adeera Levin; Vlado Perkovic; Marc A Pfeffer; Peter Rossing; Michael Walsh; Christoph Wanner; David C Wheeler; Wolfgang C Winkelmayer; John J V McMurray
Journal:  Kidney Int       Date:  2017-08       Impact factor: 10.612

9.  Timing, causes, predictors and prognosis of switching from peritoneal dialysis to hemodialysis: a prospective study.

Authors:  Bernard G Jaar; Laura C Plantinga; Deidra C Crews; Nancy E Fink; Nasser Hebah; Josef Coresh; Alan S Kliger; Neil R Powe
Journal:  BMC Nephrol       Date:  2009-02-06       Impact factor: 2.388

10.  Developing core outcome sets for clinical trials: issues to consider.

Authors:  Paula R Williamson; Douglas G Altman; Jane M Blazeby; Mike Clarke; Declan Devane; Elizabeth Gargon; Peter Tugwell
Journal:  Trials       Date:  2012-08-06       Impact factor: 2.279

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  17 in total

1.  Physical performance and health-related quality of life among older adults on peritoneal dialysis: a cross-sectional study.

Authors:  Xingjuan Tao; Haifen Zhang; Jiaying Huang; Aiping Gu; Yan Jin; Yanna He; Na Li; Yan Yang
Journal:  Int Urol Nephrol       Date:  2021-01-03       Impact factor: 2.370

2.  Effect of Low-Sodium versus Conventional Sodium Dialysate on Left Ventricular Mass in Home and Self-Care Satellite Facility Hemodialysis Patients: A Randomized Clinical Trial.

Authors:  Mark R Marshall; Alain C Vandal; Janak R de Zoysa; Ruvin S Gabriel; Imad A Haloob; Christopher J Hood; John H Irvine; Philip J Matheson; David O R McGregor; Kannaiyan S Rabindranath; John B W Schollum; David J Semple; Zhengxiu Xie; Tian Min Ma; Rose Sisk; Joanna L Dunlop
Journal:  J Am Soc Nephrol       Date:  2020-03-18       Impact factor: 10.121

3.  The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial.

Authors:  Yu-Hui Zhang; Xiao Xu; Hai-Chen Pi; Zhi-Kai Yang; David W Johnson; Jie Dong
Journal:  Trials       Date:  2019-11-28       Impact factor: 2.279

4.  Patient-reported outcome measures for life participation in peritoneal dialysis: a systematic review.

Authors:  Karine E Manera; Angela Ju; Amanda Baumgart; Elyssa Hannan; Wenjing Qiao; Martin Howell; Melissa Nataatmadja; Martin Wilkie; Fiona Loud; Daniel Schwartz; Helen Hurst; Sarbjit Vanita Jassal; Ana Figueiredo; Rajnish Mehrotra; Jenny Shen; Rachael L Morton; Thyago Moraes; Rachael Walker; Catherine Cheung; Janine F Farragher; Jonathan Craig; David W Johnson; Allison Tong
Journal:  Nephrol Dial Transplant       Date:  2021-04-26       Impact factor: 5.992

5.  Association between physical activity and mortality in end-stage kidney disease: a systematic review of observational studies.

Authors:  Pedro Martins; Elisa A Marques; Diogo V Leal; Aníbal Ferreira; Kenneth R Wilund; João L Viana
Journal:  BMC Nephrol       Date:  2021-06-18       Impact factor: 2.388

6.  Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol.

Authors:  Nathan A Pearson; Elizabeth Tutton; Alexander Joeris; Stephen Gwilym; Richard Grant; David J Keene; Kirstie L Haywood
Journal:  Trials       Date:  2021-07-12       Impact factor: 2.279

7.  Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis.

Authors:  Karine E Manera; David W Johnson; Yeoungjee Cho; Benedicte Sautenet; Jenny Shen; Ayano Kelly; Angela Yee-Moon Wang; Edwina A Brown; Gillian Brunier; Jeffrey Perl; Jie Dong; Martin Wilkie; Rajnish Mehrotra; Roberto Pecoits-Filho; Saraladevi Naicker; Tony Dunning; Jonathan C Craig; Allison Tong
Journal:  Clin Kidney J       Date:  2020-12-31

8.  Health-Related Quality of Life in Home Dialysis Patients Compared to In-Center Hemodialysis Patients: A Systematic Review and Meta-analysis.

Authors:  Anna A Bonenkamp; Anita van Eck van der Sluijs; Tiny Hoekstra; Marianne C Verhaar; Frans J van Ittersum; Alferso C Abrahams; Brigit C van Jaarsveld
Journal:  Kidney Med       Date:  2020-02-11

9.  Effects of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers on all-cause mortality, cardiovascular death, and cardiovascular events among peritoneal dialysis patients: A protocol for systematic review.

Authors:  Surapon Nochaiwong; Chidchanok Ruengorn; Pajaree Mongkhon; Kednapa Thavorn; Ratanaporn Awiphan; Kajohnsak Noppakun; Surachet Vongsanim; Wilaiwan Chongruksut; Brian Hutton; Manish M Sood; Greg A Knoll
Journal:  Medicine (Baltimore)       Date:  2020-04       Impact factor: 1.817

Review 10.  The current and future landscape of dialysis.

Authors:  Jonathan Himmelfarb; Raymond Vanholder; Rajnish Mehrotra; Marcello Tonelli
Journal:  Nat Rev Nephrol       Date:  2020-07-30       Impact factor: 28.314

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