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Influence of equipment changes on MRI measures of brain atrophy and brain microstructure in a placebo-controlled trial of ibudilast in progressive multiple sclerosis

BACKGROUND: Hardware changes can be an unavoidable confound in imaging trials. Understanding the impact of such changes may play an important role in the analysis of imaging data. OBJECTIVE: To characterize the effect of equipment changes in a longitudinal, multi-site multiple sclerosis trial. METHO...

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Autores principales: Sakaie, Ken, Fedler, Janel K, Yankey, Jon W, Nakamura, Kunio, Debbins, Josef, Lowe, Mark J, Raska, Paola, Fox, Robert J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8138298/
https://www.ncbi.nlm.nih.gov/pubmed/34046185
http://dx.doi.org/10.1177/20552173211010843
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author Sakaie, Ken
Fedler, Janel K
Yankey, Jon W
Nakamura, Kunio
Debbins, Josef
Lowe, Mark J
Raska, Paola
Fox, Robert J
author_facet Sakaie, Ken
Fedler, Janel K
Yankey, Jon W
Nakamura, Kunio
Debbins, Josef
Lowe, Mark J
Raska, Paola
Fox, Robert J
author_sort Sakaie, Ken
collection PubMed
description BACKGROUND: Hardware changes can be an unavoidable confound in imaging trials. Understanding the impact of such changes may play an important role in the analysis of imaging data. OBJECTIVE: To characterize the effect of equipment changes in a longitudinal, multi-site multiple sclerosis trial. METHODS: Using data from a clinical trial in progressive multiple sclerosis, we explored how major changes in imaging hardware affected data. We analyzed the extent to which these changes affected imaging biomarkers and the estimated treatment effects by including such changes as a time-dependent covariate. RESULTS: Significant differences whole brain atrophy (brain parenchymal fraction, BPF) and microstructure (transverse diffusivity, TD) between scans with and without changes were found and depended on the type of hardware change. A switch from GE HDxt to Siemens Skyra led to significant shifts in BPF (p < 0.04) and TD (p < 0.0001). However, we could not detect the influence of hardware changes on overall trial outcomes– differences between placebo and treatment arms in change over time of BPF and TD (p > 0.5). CONCLUSIONS: The results suggest that differences among hardware types should be considered when planning and analyzing brain atrophy and diffusivity in a longitudinal clinical trial.
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spelling pubmed-81382982021-05-26 Influence of equipment changes on MRI measures of brain atrophy and brain microstructure in a placebo-controlled trial of ibudilast in progressive multiple sclerosis Sakaie, Ken Fedler, Janel K Yankey, Jon W Nakamura, Kunio Debbins, Josef Lowe, Mark J Raska, Paola Fox, Robert J Mult Scler J Exp Transl Clin Original Research Article BACKGROUND: Hardware changes can be an unavoidable confound in imaging trials. Understanding the impact of such changes may play an important role in the analysis of imaging data. OBJECTIVE: To characterize the effect of equipment changes in a longitudinal, multi-site multiple sclerosis trial. METHODS: Using data from a clinical trial in progressive multiple sclerosis, we explored how major changes in imaging hardware affected data. We analyzed the extent to which these changes affected imaging biomarkers and the estimated treatment effects by including such changes as a time-dependent covariate. RESULTS: Significant differences whole brain atrophy (brain parenchymal fraction, BPF) and microstructure (transverse diffusivity, TD) between scans with and without changes were found and depended on the type of hardware change. A switch from GE HDxt to Siemens Skyra led to significant shifts in BPF (p < 0.04) and TD (p < 0.0001). However, we could not detect the influence of hardware changes on overall trial outcomes– differences between placebo and treatment arms in change over time of BPF and TD (p > 0.5). CONCLUSIONS: The results suggest that differences among hardware types should be considered when planning and analyzing brain atrophy and diffusivity in a longitudinal clinical trial. SAGE Publications 2021-05-18 /pmc/articles/PMC8138298/ /pubmed/34046185 http://dx.doi.org/10.1177/20552173211010843 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Research Article
Sakaie, Ken
Fedler, Janel K
Yankey, Jon W
Nakamura, Kunio
Debbins, Josef
Lowe, Mark J
Raska, Paola
Fox, Robert J
Influence of equipment changes on MRI measures of brain atrophy and brain microstructure in a placebo-controlled trial of ibudilast in progressive multiple sclerosis
title Influence of equipment changes on MRI measures of brain atrophy and brain microstructure in a placebo-controlled trial of ibudilast in progressive multiple sclerosis
title_full Influence of equipment changes on MRI measures of brain atrophy and brain microstructure in a placebo-controlled trial of ibudilast in progressive multiple sclerosis
title_fullStr Influence of equipment changes on MRI measures of brain atrophy and brain microstructure in a placebo-controlled trial of ibudilast in progressive multiple sclerosis
title_full_unstemmed Influence of equipment changes on MRI measures of brain atrophy and brain microstructure in a placebo-controlled trial of ibudilast in progressive multiple sclerosis
title_short Influence of equipment changes on MRI measures of brain atrophy and brain microstructure in a placebo-controlled trial of ibudilast in progressive multiple sclerosis
title_sort influence of equipment changes on mri measures of brain atrophy and brain microstructure in a placebo-controlled trial of ibudilast in progressive multiple sclerosis
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8138298/
https://www.ncbi.nlm.nih.gov/pubmed/34046185
http://dx.doi.org/10.1177/20552173211010843
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