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

BACKGROUND: Randomized trials can provide evidence to inform decision-making but this may be limited if the outcomes of importance to patients and clinicians are omitted or reported inconsistently. We aimed to assess the scope and heterogeneity of outcomes reported in trials in peritoneal dialysis (...

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Autores principales: Manera, Karine E, Johnson, David W, Cho, Yeoungjee, Sautenet, Benedicte, Shen, Jenny, Kelly, Ayano, Yee-Moon Wang, Angela, Brown, Edwina A, Brunier, Gillian, Perl, Jeffrey, Dong, Jie, Wilkie, Martin, Mehrotra, Rajnish, Pecoits-Filho, Roberto, Naicker, Saraladevi, Dunning, Tony, Craig, Jonathan C, Tong, Allison
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8243273/
https://www.ncbi.nlm.nih.gov/pubmed/34221389
http://dx.doi.org/10.1093/ckj/sfaa224
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author Manera, Karine E
Johnson, David W
Cho, Yeoungjee
Sautenet, Benedicte
Shen, Jenny
Kelly, Ayano
Yee-Moon Wang, Angela
Brown, Edwina A
Brunier, Gillian
Perl, Jeffrey
Dong, Jie
Wilkie, Martin
Mehrotra, Rajnish
Pecoits-Filho, Roberto
Naicker, Saraladevi
Dunning, Tony
Craig, Jonathan C
Tong, Allison
author_facet Manera, Karine E
Johnson, David W
Cho, Yeoungjee
Sautenet, Benedicte
Shen, Jenny
Kelly, Ayano
Yee-Moon Wang, Angela
Brown, Edwina A
Brunier, Gillian
Perl, Jeffrey
Dong, Jie
Wilkie, Martin
Mehrotra, Rajnish
Pecoits-Filho, Roberto
Naicker, Saraladevi
Dunning, Tony
Craig, Jonathan C
Tong, Allison
author_sort Manera, Karine E
collection PubMed
description BACKGROUND: Randomized trials can provide evidence to inform decision-making but this may be limited if the outcomes of importance to patients and clinicians are omitted or reported inconsistently. We aimed to assess the scope and heterogeneity of outcomes reported in trials in peritoneal dialysis (PD). METHODS: We searched the Cochrane Kidney and Transplant Specialized Register for randomized trials in PD. We extracted all reported outcome domains and measurements and analyzed their frequency and characteristics. RESULTS: From 128 reports of 120 included trials, 80 different outcome domains were reported. Overall, 39 (49%) domains were surrogate, 23 (29%) patient-reported and 18 (22%) clinical. The five most commonly reported domains were PD-related infection [59 (49%) trials], dialysis solute clearance [51 (42%)], kidney function [45 (38%)], protein metabolism [44 (37%)] and inflammatory markers/oxidative stress [42 (35%)]. Quality of life was reported infrequently (4% of trials). Only 14 (12%) trials included a patient-reported outcome as a primary outcome. The median number of outcome measures (defined as a different measurement, aggregation and metric) was 22 (interquartile range 13–37) per trial. PD-related infection was the most frequently reported clinical outcome as well as the most frequently stated primary outcome. A total of 383 different measures for infection were used, with 66 used more than once. CONCLUSIONS: Trials in PD include important clinical outcomes such as infection, but these are measured and reported inconsistently. Patient-reported outcomes are infrequently reported and nearly half of the domains were surrogate. Standardized outcomes for PD trials are required to improve efficiency and relevance.
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spelling pubmed-82432732021-07-01 Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis Manera, Karine E Johnson, David W Cho, Yeoungjee Sautenet, Benedicte Shen, Jenny Kelly, Ayano Yee-Moon Wang, Angela Brown, Edwina A Brunier, Gillian Perl, Jeffrey Dong, Jie Wilkie, Martin Mehrotra, Rajnish Pecoits-Filho, Roberto Naicker, Saraladevi Dunning, Tony Craig, Jonathan C Tong, Allison Clin Kidney J Original Articles BACKGROUND: Randomized trials can provide evidence to inform decision-making but this may be limited if the outcomes of importance to patients and clinicians are omitted or reported inconsistently. We aimed to assess the scope and heterogeneity of outcomes reported in trials in peritoneal dialysis (PD). METHODS: We searched the Cochrane Kidney and Transplant Specialized Register for randomized trials in PD. We extracted all reported outcome domains and measurements and analyzed their frequency and characteristics. RESULTS: From 128 reports of 120 included trials, 80 different outcome domains were reported. Overall, 39 (49%) domains were surrogate, 23 (29%) patient-reported and 18 (22%) clinical. The five most commonly reported domains were PD-related infection [59 (49%) trials], dialysis solute clearance [51 (42%)], kidney function [45 (38%)], protein metabolism [44 (37%)] and inflammatory markers/oxidative stress [42 (35%)]. Quality of life was reported infrequently (4% of trials). Only 14 (12%) trials included a patient-reported outcome as a primary outcome. The median number of outcome measures (defined as a different measurement, aggregation and metric) was 22 (interquartile range 13–37) per trial. PD-related infection was the most frequently reported clinical outcome as well as the most frequently stated primary outcome. A total of 383 different measures for infection were used, with 66 used more than once. CONCLUSIONS: Trials in PD include important clinical outcomes such as infection, but these are measured and reported inconsistently. Patient-reported outcomes are infrequently reported and nearly half of the domains were surrogate. Standardized outcomes for PD trials are required to improve efficiency and relevance. Oxford University Press 2020-12-31 /pmc/articles/PMC8243273/ /pubmed/34221389 http://dx.doi.org/10.1093/ckj/sfaa224 Text en © The Author(s) 2020. Published by Oxford University Press on behalf of ERA-EDTA. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Articles
Manera, Karine E
Johnson, David W
Cho, Yeoungjee
Sautenet, Benedicte
Shen, Jenny
Kelly, Ayano
Yee-Moon Wang, Angela
Brown, Edwina A
Brunier, Gillian
Perl, Jeffrey
Dong, Jie
Wilkie, Martin
Mehrotra, Rajnish
Pecoits-Filho, Roberto
Naicker, Saraladevi
Dunning, Tony
Craig, Jonathan C
Tong, Allison
Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis
title Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis
title_full Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis
title_fullStr Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis
title_full_unstemmed Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis
title_short Scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis
title_sort scope and heterogeneity of outcomes reported in randomized trials in patients receiving peritoneal dialysis
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8243273/
https://www.ncbi.nlm.nih.gov/pubmed/34221389
http://dx.doi.org/10.1093/ckj/sfaa224
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