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Common Data Elements Reported in Mechanical Thrombectomy for Acute Ischemic Stroke: A Systematic Review of Active Clinical Trials

Background: New trials are planned regularly to provide the highest quality of evidence and invade new occlusion territories, which requires a pre-defined reporting strategy with consistent, common data elements for more straightforward collective evidence synthesis. We sought to review all active e...

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Autores principales: Ghozy, Sherief, Hardy, Nicole, Sutphin, Daniel J., Kallmes, Kevin M., Kadirvel, Ramanathan, Kallmes, David F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9775042/
https://www.ncbi.nlm.nih.gov/pubmed/36552140
http://dx.doi.org/10.3390/brainsci12121679
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author Ghozy, Sherief
Hardy, Nicole
Sutphin, Daniel J.
Kallmes, Kevin M.
Kadirvel, Ramanathan
Kallmes, David F.
author_facet Ghozy, Sherief
Hardy, Nicole
Sutphin, Daniel J.
Kallmes, Kevin M.
Kadirvel, Ramanathan
Kallmes, David F.
author_sort Ghozy, Sherief
collection PubMed
description Background: New trials are planned regularly to provide the highest quality of evidence and invade new occlusion territories, which requires a pre-defined reporting strategy with consistent, common data elements for more straightforward collective evidence synthesis. We sought to review all active endovascular thrombectomy trials to investigate their patient selection criteria, intervention description, and reported outcomes. Methods: A literature search was systematically conducted on clinicaltrials.gov for active trials and all intervention, inclusion criteria, and outcomes reported were extracted. A qualitative synthesis of the frequency of study design types and data elements are graphically and narratively presented. Results: A total of 32 studies were tagged and included in the final qualitative analysis. The inclusion criteria were highly variable, including different cut-offs for the last well-known baseline National Institutes of Health Stroke Scale, Alberta Stroke Program Early CT Score, and modified Rankin scale (mRS). Half of the studies (16/32) mentioned “thrombectomy” without defining which technique or device was used, and the final thrombolysis in cerebral infarction scale was provided in 19 (59.4%) studies. Heterogeneity was also present among the studies reporting a first-pass effect, both in how studies defined the outcome and in used ranges for mRS. Mortality and intracerebral hemorrhage (ICH) were more homogenous in their presentation and follow-up. Conclusions: There is a great degree of heterogeneity in the active thrombectomy trials concerning inclusion criteria, interventions used, and how outcomes are being reported.
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spelling pubmed-97750422022-12-23 Common Data Elements Reported in Mechanical Thrombectomy for Acute Ischemic Stroke: A Systematic Review of Active Clinical Trials Ghozy, Sherief Hardy, Nicole Sutphin, Daniel J. Kallmes, Kevin M. Kadirvel, Ramanathan Kallmes, David F. Brain Sci Review Background: New trials are planned regularly to provide the highest quality of evidence and invade new occlusion territories, which requires a pre-defined reporting strategy with consistent, common data elements for more straightforward collective evidence synthesis. We sought to review all active endovascular thrombectomy trials to investigate their patient selection criteria, intervention description, and reported outcomes. Methods: A literature search was systematically conducted on clinicaltrials.gov for active trials and all intervention, inclusion criteria, and outcomes reported were extracted. A qualitative synthesis of the frequency of study design types and data elements are graphically and narratively presented. Results: A total of 32 studies were tagged and included in the final qualitative analysis. The inclusion criteria were highly variable, including different cut-offs for the last well-known baseline National Institutes of Health Stroke Scale, Alberta Stroke Program Early CT Score, and modified Rankin scale (mRS). Half of the studies (16/32) mentioned “thrombectomy” without defining which technique or device was used, and the final thrombolysis in cerebral infarction scale was provided in 19 (59.4%) studies. Heterogeneity was also present among the studies reporting a first-pass effect, both in how studies defined the outcome and in used ranges for mRS. Mortality and intracerebral hemorrhage (ICH) were more homogenous in their presentation and follow-up. Conclusions: There is a great degree of heterogeneity in the active thrombectomy trials concerning inclusion criteria, interventions used, and how outcomes are being reported. MDPI 2022-12-07 /pmc/articles/PMC9775042/ /pubmed/36552140 http://dx.doi.org/10.3390/brainsci12121679 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Ghozy, Sherief
Hardy, Nicole
Sutphin, Daniel J.
Kallmes, Kevin M.
Kadirvel, Ramanathan
Kallmes, David F.
Common Data Elements Reported in Mechanical Thrombectomy for Acute Ischemic Stroke: A Systematic Review of Active Clinical Trials
title Common Data Elements Reported in Mechanical Thrombectomy for Acute Ischemic Stroke: A Systematic Review of Active Clinical Trials
title_full Common Data Elements Reported in Mechanical Thrombectomy for Acute Ischemic Stroke: A Systematic Review of Active Clinical Trials
title_fullStr Common Data Elements Reported in Mechanical Thrombectomy for Acute Ischemic Stroke: A Systematic Review of Active Clinical Trials
title_full_unstemmed Common Data Elements Reported in Mechanical Thrombectomy for Acute Ischemic Stroke: A Systematic Review of Active Clinical Trials
title_short Common Data Elements Reported in Mechanical Thrombectomy for Acute Ischemic Stroke: A Systematic Review of Active Clinical Trials
title_sort common data elements reported in mechanical thrombectomy for acute ischemic stroke: a systematic review of active clinical trials
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9775042/
https://www.ncbi.nlm.nih.gov/pubmed/36552140
http://dx.doi.org/10.3390/brainsci12121679
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