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

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. Methods...

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Veröffentlicht in:Multiple sclerosis journal - experimental, translational and clinical translational and clinical, 2021-04, Vol.7 (2), p.20552173211010843-20552173211010843
Hauptverfasser: Sakaie, Ken, Fedler, Janel K, Yankey, Jon W, Nakamura, Kunio, Debbins, Josef, Lowe, Mark J, Raska, Paola, Fox, Robert J
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Atrophy
Clinical trials
Multiple sclerosis
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container_issue 2
container_start_page 20552173211010843
container_title Multiple sclerosis journal - experimental, translational and clinical
container_volume 7
creator Sakaie, Ken
Fedler, Janel K
Yankey, Jon W
Nakamura, Kunio
Debbins, Josef
Lowe, Mark J
Raska, Paola
Fox, Robert J
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 
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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 &lt; 0.04) and TD (p &lt; 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 &gt; 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.</description><identifier>ISSN: 2055-2173</identifier><identifier>EISSN: 2055-2173</identifier><identifier>DOI: 10.1177/20552173211010843</identifier><identifier>PMID: 34046185</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Atrophy ; Clinical trials ; Multiple sclerosis ; Original</subject><ispartof>Multiple sclerosis journal - experimental, translational and clinical, 2021-04, Vol.7 (2), p.20552173211010843-20552173211010843</ispartof><rights>The Author(s) 2021</rights><rights>The Author(s) 2021.</rights><rights>The Author(s) 2021. This work is licensed under the Creative Commons Attribution – Non-Commercial License https://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2021 2021 SAGE Publications Ltd unless otherwise noted. 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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 &lt; 0.04) and TD (p &lt; 0.0001). 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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 &lt; 0.04) and TD (p &lt; 0.0001). 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subjects Atrophy
Clinical trials
Multiple sclerosis
Original
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
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