Evidence map›Paper›PMID 34046185›Full record

ArticleMultiple sclerosis journal - experimental, translational and clinical

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

Ken Sakaie, Janel K Fedler, Jon W Yankey, Kunio Nakamura, Josef Debbins, Mark J Lowe, Paola Raska, Robert J Fox

Open access · goldAbstract read
In one paragraph

Article in Multiple sclerosis journal - experimental, translational and clinical. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 53% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. Diffusion tensor imaging in the SPRINT-MS clinical trial: Advancing trial methodology.Multiple sclerosis journal - experimental, translational and clinical
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Ken SakaieImaging Institute, The Cleveland Clinic, Cleveland, OH, USA.ORCID https://orcid.org/0000-0002-5633-4494
Janel K FedlerData Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, USA.
Jon W YankeyData Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, USA.
Kunio NakamuraBiomedical Engineering, Lerner Research Institute, The Cleveland Clinic, Cleveland, OH, USA.ORCID https://orcid.org/0000-0002-7833-8138
Josef DebbinsKeller Center for Imaging Innovation, Barrow Neurological Institute, Phoenix, AZ, USA.
Mark J LoweImaging Institute, The Cleveland Clinic, Cleveland, OH, USA.
Paola RaskaQuantitative Health Sciences, Lerner Research Institute, Cleveland, OH, USA.
Robert J FoxMellen Center for Multiple Sclerosis, Neurological Institute, The Cleveland Clinic, Cleveland, OH, USA.ORCID https://orcid.org/0000-0002-4263-3717
Cleveland Clinic · USUniversity of Iowa · US

Funding

Clinical Coordinating Center Network of Excellence in Neuroscience Clinical TrialU01NS077179 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI Merit E CUDKOWICZ, Aleksandar Videnovic · 2011 to 2026
$43.4M
Network of Excellence in Neuroscience Clinical Trials (NEXT)-DCCU01NS077352 · NINDS · UNIVERSITY OF IOWA · PI CHRISTOPHER S. COFFEY · 2011 to 2026
$28.1M
Ibudilast Phase II trial in progressive MSU01NS082329 · NINDS · CLEVELAND CLINIC LERNER COM-CWRU · PI FOX, ROBERT J. · 2013 to 2017
$12.5M
Vanderbilt Site for Network of Excellence in Neuroscience Clinical TrialsU24NS107128 · NINDS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Philip David Charles, Amanda C Peltier · 2018 to 2026
$3.5M
NINDS NIH HHS U01 NS077179NINDS NIH HHS U01 NS077352NINDS NIH HHS U01 NS082329NINDS NIH HHS U24 NS107128
6 · The paper itself

Abstract

backgroundHardware 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.

objectiveTo characterize the effect of equipment changes in a longitudinal, multi-site multiple sclerosis trial.

methodsUsing 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.

resultsSignificant 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).

conclusionsThe results suggest that differences among hardware types should be considered when planning and analyzing brain atrophy and diffusivity in a longitudinal clinical trial.

Indexed as

biomarkersbrain parenchymal fractionclinical trialdiffusion tensor imagingdiffusivityMultiple sclerosis

Identifiers

PMID34046185
PMCPMC8138298
OpenAlexW3163217735

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.