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Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach

BACKGROUND: Data monitoring of clinical trials is a tool aimed at reducing the risks of random errors (e.g. clerical errors) and systematic errors, which include misinterpretation, misunderstandings, and fabrication. Traditional ‘good clinical practice data monitoring’ with on-site monitors increase...

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Autores principales: Olsen, Markus Harboe, Hansen, Mathias Lühr, Safi, Sanam, Jakobsen, Janus Christian, Greisen, Gorm, Gluud, Christian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8325420/
https://www.ncbi.nlm.nih.gov/pubmed/34332547
http://dx.doi.org/10.1186/s12874-021-01344-4
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author Olsen, Markus Harboe
Hansen, Mathias Lühr
Safi, Sanam
Jakobsen, Janus Christian
Greisen, Gorm
Gluud, Christian
author_facet Olsen, Markus Harboe
Hansen, Mathias Lühr
Safi, Sanam
Jakobsen, Janus Christian
Greisen, Gorm
Gluud, Christian
author_sort Olsen, Markus Harboe
collection PubMed
description BACKGROUND: Data monitoring of clinical trials is a tool aimed at reducing the risks of random errors (e.g. clerical errors) and systematic errors, which include misinterpretation, misunderstandings, and fabrication. Traditional ‘good clinical practice data monitoring’ with on-site monitors increases trial costs and is time consuming for the local investigators. This paper aims to outline our approach of time-effective central data monitoring for the SafeBoosC-III multicentre randomised clinical trial and present the results from the first three central data monitoring meetings. METHODS: The present approach to central data monitoring was implemented for the SafeBoosC-III trial, a large, pragmatic, multicentre, randomised clinical trial evaluating the benefits and harms of treatment based on cerebral oxygenation monitoring in preterm infants during the first days of life versus monitoring and treatment as usual. We aimed to optimise completeness and quality and to minimise deviations, thereby limiting random and systematic errors. We designed an automated report which was blinded to group allocation, to ease the work of data monitoring. The central data monitoring group first reviewed the data using summary plots only, and thereafter included the results of the multivariate Mahalanobis distance of each centre from the common mean. The decisions of the group were manually added to the reports for dissemination, information, correcting errors, preventing furture errors and documentation. RESULTS: The first three central monitoring meetings identified 156 entries of interest, decided upon contacting the local investigators for 146 of these, which resulted in correction of 53 entries. Multiple systematic errors and protocol violations were identified, one of these included 103/818 randomised participants. Accordingly, the electronic participant record form (ePRF) was improved to reduce ambiguity. DISCUSSION: We present a methodology for central data monitoring to optimise quality control and quality development. The initial results included identification of random errors in data entries leading to correction of the ePRF, systematic protocol violations, and potential protocol adherence issues. Central data monitoring may optimise concurrent data completeness and may help timely detection of data deviations due to misunderstandings or fabricated data. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-021-01344-4.
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spelling pubmed-83254202021-08-02 Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach Olsen, Markus Harboe Hansen, Mathias Lühr Safi, Sanam Jakobsen, Janus Christian Greisen, Gorm Gluud, Christian BMC Med Res Methodol Research BACKGROUND: Data monitoring of clinical trials is a tool aimed at reducing the risks of random errors (e.g. clerical errors) and systematic errors, which include misinterpretation, misunderstandings, and fabrication. Traditional ‘good clinical practice data monitoring’ with on-site monitors increases trial costs and is time consuming for the local investigators. This paper aims to outline our approach of time-effective central data monitoring for the SafeBoosC-III multicentre randomised clinical trial and present the results from the first three central data monitoring meetings. METHODS: The present approach to central data monitoring was implemented for the SafeBoosC-III trial, a large, pragmatic, multicentre, randomised clinical trial evaluating the benefits and harms of treatment based on cerebral oxygenation monitoring in preterm infants during the first days of life versus monitoring and treatment as usual. We aimed to optimise completeness and quality and to minimise deviations, thereby limiting random and systematic errors. We designed an automated report which was blinded to group allocation, to ease the work of data monitoring. The central data monitoring group first reviewed the data using summary plots only, and thereafter included the results of the multivariate Mahalanobis distance of each centre from the common mean. The decisions of the group were manually added to the reports for dissemination, information, correcting errors, preventing furture errors and documentation. RESULTS: The first three central monitoring meetings identified 156 entries of interest, decided upon contacting the local investigators for 146 of these, which resulted in correction of 53 entries. Multiple systematic errors and protocol violations were identified, one of these included 103/818 randomised participants. Accordingly, the electronic participant record form (ePRF) was improved to reduce ambiguity. DISCUSSION: We present a methodology for central data monitoring to optimise quality control and quality development. The initial results included identification of random errors in data entries leading to correction of the ePRF, systematic protocol violations, and potential protocol adherence issues. Central data monitoring may optimise concurrent data completeness and may help timely detection of data deviations due to misunderstandings or fabricated data. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-021-01344-4. BioMed Central 2021-07-31 /pmc/articles/PMC8325420/ /pubmed/34332547 http://dx.doi.org/10.1186/s12874-021-01344-4 Text en © The Author(s) 2021 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/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Olsen, Markus Harboe
Hansen, Mathias Lühr
Safi, Sanam
Jakobsen, Janus Christian
Greisen, Gorm
Gluud, Christian
Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach
title Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach
title_full Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach
title_fullStr Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach
title_full_unstemmed Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach
title_short Central data monitoring in the multicentre randomised SafeBoosC-III trial – a pragmatic approach
title_sort central data monitoring in the multicentre randomised safeboosc-iii trial – a pragmatic approach
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8325420/
https://www.ncbi.nlm.nih.gov/pubmed/34332547
http://dx.doi.org/10.1186/s12874-021-01344-4
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