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Establishing a Core Outcome Set for Peritoneal Dialysis: Report of the SONG-PD (Standardized Outcomes in Nephrology-Peritoneal Dialysis) Consensus Workshop.

Published on Mar 1, 2020in American Journal of Kidney Diseases6.653
· DOI :10.1053/J.AJKD.2019.09.017
Karine E. Manera5
Estimated H-index: 5
(USYD: University of Sydney),
David W. Johnson114
Estimated H-index: 114
+ 109 AuthorsZeeshan Butt23
Estimated H-index: 23
Abstract
Outcomes reported in randomized controlled trials in peritoneal dialysis (PD) are diverse, are measured inconsistently, and may not be important to patients, families, and clinicians. The Standardized Outcomes in Nephrology–Peritoneal Dialysis (SONG-PD) initiative aims to establish a core outcome set for trials in PD based on the shared priorities of all stakeholders. We convened an international SONG-PD stakeholder consensus workshop in May 2018 in Vancouver, Canada. Nineteen patients/caregivers and 51 health professionals attended. Participants discussed core outcome domains and implementation in trials in PD. Four themes relating to the formation of core outcome domains were identified: life participation as a main goal of PD, impact of fatigue, empowerment for preparation and planning, and separation of contributing factors from core factors. Considerations for implementation were identified: standardizing patient-reported outcomes, requiring a validated and feasible measure, simplicity of binary outcomes, responsiveness to interventions, and using positive terminology. All stakeholders supported inclusion of PD-related infection, cardiovascular disease, mortality, technique survival, and life participation as the core outcome domains for PD.
  • References (21)
  • Citations (1)
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References21
Newest
#1Karine E. Manera (USYD: University of Sydney)H-Index: 5
#2Allison Tong (USYD: University of Sydney)H-Index: 41
Last. David W. JohnsonH-Index: 114
view all 21 authors...
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 indicati...
1 CitationsSource
#1Jack Jacobson (USYD: University of Sydney)H-Index: 1
#2Angela Ju (USYD: University of Sydney)H-Index: 8
Last. Allison Tong (USYD: University of Sydney)H-Index: 41
view all 16 authors...
Rationale & Objective Fatigue is a highly prevalent and debilitating symptom in patients on hemodialysis therapy due to the uremic milieu, the hemodialysis treatment itself, and other comorbid conditions. However, fatigue remains underrecognized and the consequences are underappreciated because it may not be visible in clinical settings. This study aims to describe the experience that patients undergoing maintenance hemodialysis have with fatigue. Study Design Systematic review and thematic synt...
1 CitationsSource
#1Karine E. Manera (USYD: University of Sydney)H-Index: 5
#2David W. Johnson (UQ: University of Queensland)H-Index: 114
Last. Allison Tong (USYD: University of Sydney)H-Index: 41
view all 24 authors...
Background and objectives The absence of accepted patient-centered outcomes in research can limit shared decision-making in peritoneal dialysis (PD), particularly because PD-related treatments can be associated with mortality, technique failure, and complications that can impair quality of life. We aimed to identify patient and caregiver priorities for outcomes in PD, and to describe the reasons for their choices. Design, setting, participants, & measurements Patients on PD and their caregivers ...
6 CitationsSource
#1Allison Tong (USYD: University of Sydney)H-Index: 41
#2Braden J. Manns (U of C: University of Calgary)H-Index: 70
Last. Zeeshan ButtH-Index: 23
view all 186 authors...
There are an estimated 14,000 randomized trials published in chronic kidney disease. The most frequently reported outcomes are biochemical endpoints, rather than clinical and patient-reported outcomes including cardiovascular disease, mortality, and quality of life. While many trials have focused on optimizing kidney health, the heterogeneity and uncertain relevance of outcomes reported across trials may limit their policy and practice impact. The international Standardized Outcomes in Nephrolog...
8 CitationsSource
#1Karine E. Manera (USYD: University of Sydney)H-Index: 5
#2Allison Tong (USYD: University of Sydney)H-Index: 41
Last. David W. Johnson (Princess Alexandra Hospital)H-Index: 114
view all 18 authors...
Background: Worldwide, approximately 11% of patients on dialysis receive peritoneal dialysis (PD). Whilst PD may offer more autonomy to patients compared with hemodialysis, patient and caregiver burnout, technique failure, and peritonitis remain major challenges to the success of PD. Improvements in care and outcomes are likely to be mediated by randomized trials of innovative therapies, but will be limited if the outcomes measured and reported are not important for patients and clinicians. The ...
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#1Colin Baigent (Medical Research Council)H-Index: 66
#2William G. Herrington (Clinical Trial Service Unit)H-Index: 18
Last. Faiez ZannadH-Index: 93
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Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable information available to guide the care of such patients is very limited. Some treatments have been assessed in randomized trials, but most such trials have been too small to detect treatment effects of a magnitude that would be realistic to achieve with a single intervention. Therefore, KDIGO convened an international, multidisciplinary controversies conference titled "Ch...
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#1Paula R. Williamson (University of Liverpool)H-Index: 64
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Last. Bridget Young (University of Liverpool)H-Index: 35
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The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials...
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#1Mike Clarke ('QUB': Queen's University Belfast)H-Index: 99
#2Paula R. Williamson (University of Liverpool)H-Index: 64
Systematic reviews seek to bring together research evidence to answer the question for the review. The reviewers usually wish to compare, contrast and, if appropriate, combine the findings of the existing research studies. However, these intentions are often thwarted by inconsistencies in the outcomes that were measured and reported in the individual studies. This, in turn, makes it difficult for readers of the review to use it to make informed decisions and choices about health and social care....
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#1Bridget Young (University of Liverpool)H-Index: 35
#2Heather Bagley (University of Liverpool)H-Index: 4
This commentary article describes three interactive workshops that explored how patients can contribute to decisions about what outcomes are measured in clinical trials across the world. Outcomes like quality of life, side-effects and pain are used in trials to measure whether a treatment is effective. Here, we outline how research groups are increasingly coming together to develop ‘core outcomes sets’ for particular conditions. Core outcome sets are lists of agreed outcomes. Their use will help...
23 CitationsSource
#1Cecilia A.C. Prinsen (VUmc: VU University Medical Center)H-Index: 16
#2Sunita Vohra (U of A: University of Alberta)H-Index: 35
Last. Caroline B. Terwee (VUmc: VU University Medical Center)H-Index: 61
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Background In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a “Core Outcome Set” (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial po...
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