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Missing trial results: analysis of the current publication rate of studies in pediatric dialysis from 2003 to 2020

BACKGROUND: Decision-making in the field of pediatric dialysis requires evidence from clinical trials, but, similar to other fields of pediatric medicine, might be affected by a low trial publication rate. METHODS: We analyzed the current publication rate, the time to publication, and factors that m...

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Autores principales: Patry, Christian, Fichtner, Alexander, Höcker, Britta, Ries, Markus, Schmitt, Claus Peter, Tönshoff, Burkhard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9747852/
https://www.ncbi.nlm.nih.gov/pubmed/35460394
http://dx.doi.org/10.1007/s00467-022-05553-x
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author Patry, Christian
Fichtner, Alexander
Höcker, Britta
Ries, Markus
Schmitt, Claus Peter
Tönshoff, Burkhard
author_facet Patry, Christian
Fichtner, Alexander
Höcker, Britta
Ries, Markus
Schmitt, Claus Peter
Tönshoff, Burkhard
author_sort Patry, Christian
collection PubMed
description BACKGROUND: Decision-making in the field of pediatric dialysis requires evidence from clinical trials, but, similar to other fields of pediatric medicine, might be affected by a low trial publication rate. METHODS: We analyzed the current publication rate, the time to publication, and factors that might be associated with both rate of and time to publication in pediatric dialysis studies registered as completed on ClinicalTrials.gov from 2003 until November 2020. RESULTS: Fifty-three respective studies were identified. These enrolled 7287 patients in total. 28 of 53 studies (52.8%) had results available. We identified a median time to publication of 20.5 months (range, 3–67). Studies published after the FDA Amendments Act establishment in 2007 were published faster (P = 0.025). There was no trend toward a higher publication rate of studies completed more recently (P = 0.431). 26 of 53 studies (49.1%) focused on medication and control of secondary complications of kidney failure. 12 of 53 studies (22.6%) enrolled only children, were published faster (P = 0.029) and had a higher 5-year publication rate (P = 0.038) than studies enrolling both children and adults. 25 of 53 studies (47.1%) were co-funded by industry. These were published faster (P = 0.025). CONCLUSIONS: Currently, only 52.8% of all investigated studies in pediatric dialysis have available results, and the overall median time to publication did not meet FDA requirements. This might introduce a publication bias into the field, and it might negatively impact clinical decision-making in this critical subspecialty of pediatric medicine. GRAPHICAL ABSTRACT: A higher resolution version of the Graphical abstract is available as Supplementary information [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material including a graphical abstract available at 10.1007/s00467-022-05553-x.
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spelling pubmed-97478522022-12-15 Missing trial results: analysis of the current publication rate of studies in pediatric dialysis from 2003 to 2020 Patry, Christian Fichtner, Alexander Höcker, Britta Ries, Markus Schmitt, Claus Peter Tönshoff, Burkhard Pediatr Nephrol Original Article BACKGROUND: Decision-making in the field of pediatric dialysis requires evidence from clinical trials, but, similar to other fields of pediatric medicine, might be affected by a low trial publication rate. METHODS: We analyzed the current publication rate, the time to publication, and factors that might be associated with both rate of and time to publication in pediatric dialysis studies registered as completed on ClinicalTrials.gov from 2003 until November 2020. RESULTS: Fifty-three respective studies were identified. These enrolled 7287 patients in total. 28 of 53 studies (52.8%) had results available. We identified a median time to publication of 20.5 months (range, 3–67). Studies published after the FDA Amendments Act establishment in 2007 were published faster (P = 0.025). There was no trend toward a higher publication rate of studies completed more recently (P = 0.431). 26 of 53 studies (49.1%) focused on medication and control of secondary complications of kidney failure. 12 of 53 studies (22.6%) enrolled only children, were published faster (P = 0.029) and had a higher 5-year publication rate (P = 0.038) than studies enrolling both children and adults. 25 of 53 studies (47.1%) were co-funded by industry. These were published faster (P = 0.025). CONCLUSIONS: Currently, only 52.8% of all investigated studies in pediatric dialysis have available results, and the overall median time to publication did not meet FDA requirements. This might introduce a publication bias into the field, and it might negatively impact clinical decision-making in this critical subspecialty of pediatric medicine. GRAPHICAL ABSTRACT: A higher resolution version of the Graphical abstract is available as Supplementary information [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material including a graphical abstract available at 10.1007/s00467-022-05553-x. Springer Berlin Heidelberg 2022-04-23 2023 /pmc/articles/PMC9747852/ /pubmed/35460394 http://dx.doi.org/10.1007/s00467-022-05553-x Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
Patry, Christian
Fichtner, Alexander
Höcker, Britta
Ries, Markus
Schmitt, Claus Peter
Tönshoff, Burkhard
Missing trial results: analysis of the current publication rate of studies in pediatric dialysis from 2003 to 2020
title Missing trial results: analysis of the current publication rate of studies in pediatric dialysis from 2003 to 2020
title_full Missing trial results: analysis of the current publication rate of studies in pediatric dialysis from 2003 to 2020
title_fullStr Missing trial results: analysis of the current publication rate of studies in pediatric dialysis from 2003 to 2020
title_full_unstemmed Missing trial results: analysis of the current publication rate of studies in pediatric dialysis from 2003 to 2020
title_short Missing trial results: analysis of the current publication rate of studies in pediatric dialysis from 2003 to 2020
title_sort missing trial results: analysis of the current publication rate of studies in pediatric dialysis from 2003 to 2020
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9747852/
https://www.ncbi.nlm.nih.gov/pubmed/35460394
http://dx.doi.org/10.1007/s00467-022-05553-x
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