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Cochlear Implant Reliability: On the Reporting of Rates of Revision Surgery

The aim of this study was to determine the magnitude of the risks associated with cochlear implantation. Results from a pool of thirty clinical studies involving cochlear implantation in over 6300 children were obtained from an internet search. The relevant data were transformed to a common time bas...

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Autores principales: O’Neill, Graham, Tolley, Neil S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer India 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7276475/
https://www.ncbi.nlm.nih.gov/pubmed/32550150
http://dx.doi.org/10.1007/s12070-020-01795-z
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author O’Neill, Graham
Tolley, Neil S.
author_facet O’Neill, Graham
Tolley, Neil S.
author_sort O’Neill, Graham
collection PubMed
description The aim of this study was to determine the magnitude of the risks associated with cochlear implantation. Results from a pool of thirty clinical studies involving cochlear implantation in over 6300 children were obtained from an internet search. The relevant data were transformed to a common time base (patient time) to allow an evaluation of events following implantation. The main outcome measure was cumulative survival probability for all-cause revision surgery. Over 10 years this was estimated to be 0.71. Thus, at 10 years post-implantation close to 30% of children with unilateral implants will have undergone revision surgery. This figure is considerably greater than that commonly reported for overall revision rates and illustrates the importance of interpreting results with respect to the relevant time frame. When non and low-use is incorporated into the analysis the above figure rises to about 37% of children affected. The findings raise concerns about the information provided to both individuals and regulatory bodies regarding the risks associated with cochlear implantation. The consequences for bilateral implantation are apparent. Our recommendations are i) a full disclosure to parents and children of the true magnitude of the risks and ii) for a body with significant expertise in reliability and systems engineering, and no conflicts of interest, to play a major role in the regulatory management of this service.
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spelling pubmed-72764752020-06-16 Cochlear Implant Reliability: On the Reporting of Rates of Revision Surgery O’Neill, Graham Tolley, Neil S. Indian J Otolaryngol Head Neck Surg Original Article The aim of this study was to determine the magnitude of the risks associated with cochlear implantation. Results from a pool of thirty clinical studies involving cochlear implantation in over 6300 children were obtained from an internet search. The relevant data were transformed to a common time base (patient time) to allow an evaluation of events following implantation. The main outcome measure was cumulative survival probability for all-cause revision surgery. Over 10 years this was estimated to be 0.71. Thus, at 10 years post-implantation close to 30% of children with unilateral implants will have undergone revision surgery. This figure is considerably greater than that commonly reported for overall revision rates and illustrates the importance of interpreting results with respect to the relevant time frame. When non and low-use is incorporated into the analysis the above figure rises to about 37% of children affected. The findings raise concerns about the information provided to both individuals and regulatory bodies regarding the risks associated with cochlear implantation. The consequences for bilateral implantation are apparent. Our recommendations are i) a full disclosure to parents and children of the true magnitude of the risks and ii) for a body with significant expertise in reliability and systems engineering, and no conflicts of interest, to play a major role in the regulatory management of this service. Springer India 2020-04-01 2020-06 /pmc/articles/PMC7276475/ /pubmed/32550150 http://dx.doi.org/10.1007/s12070-020-01795-z Text en © The Author(s) 2020 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/.
spellingShingle Original Article
O’Neill, Graham
Tolley, Neil S.
Cochlear Implant Reliability: On the Reporting of Rates of Revision Surgery
title Cochlear Implant Reliability: On the Reporting of Rates of Revision Surgery
title_full Cochlear Implant Reliability: On the Reporting of Rates of Revision Surgery
title_fullStr Cochlear Implant Reliability: On the Reporting of Rates of Revision Surgery
title_full_unstemmed Cochlear Implant Reliability: On the Reporting of Rates of Revision Surgery
title_short Cochlear Implant Reliability: On the Reporting of Rates of Revision Surgery
title_sort cochlear implant reliability: on the reporting of rates of revision surgery
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7276475/
https://www.ncbi.nlm.nih.gov/pubmed/32550150
http://dx.doi.org/10.1007/s12070-020-01795-z
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