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The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment
Background and Purpose: Recent noninferiority clinical trials of novel endovascular thrombectomy devices for acute ischemic stroke have used substantial reperfusion as the primary outcome of achievement. Determining the minimal clinically important difference (MCID) is an essential step for the desi...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7569750/ https://www.ncbi.nlm.nih.gov/pubmed/33123069 http://dx.doi.org/10.3389/fneur.2020.524220 |
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author | Lin, Chun-Jen Saver, Jeffrey L. |
author_facet | Lin, Chun-Jen Saver, Jeffrey L. |
author_sort | Lin, Chun-Jen |
collection | PubMed |
description | Background and Purpose: Recent noninferiority clinical trials of novel endovascular thrombectomy devices for acute ischemic stroke have used substantial reperfusion as the primary outcome of achievement. Determining the minimal clinically important difference (MCID) is an essential step for the design of noninferiority clinical trials. Materials and Methods: We surveyed international neuro-interventionalist and noninterventional vascular neurologist investigators. The questionnaire included demographic characteristics, level of clinical experience, and their MCID clinical scenario-based judgment regarding the MCID for the outcome substantial reperfusion (thrombolysis in cerebral infarction score 2b-3) within 3 passes. Results: Survey responses were received from 58 of 200 experts. Among responders, 75.9% were neuro-interventionalists (most commonly interventional neuroradiologists and interventional neurologists, followed by endovascular neurosurgeons), and 24.1% were noninterventional vascular neurologists; 87.9% had been in practice for more than 5 years, and 67.3% devoted more than half of their practice to stroke care. Responder–nonresponder and continuum of resistance analysis indicated responders were representative of the full expert population. Among experts, the median MCID for substantial reperfusion was 3.1–5% (interquartile range 1.1–3% to 5.1–10%). MCID distributions did not differ among neuro-interventionalists and noninterventional vascular neurologists. Conclusions: Neuro-interventionl and noninterventional stroke experts judged that the minimal clinically important difference in comparing thrombectomy devices for achieving substantial reperfusion is 3.1–5%. This MCID, lower than noninferiority margins used in several recent clinical trials, can inform trial designs and clinical development. |
format | Online Article Text |
id | pubmed-7569750 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-75697502020-10-28 The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment Lin, Chun-Jen Saver, Jeffrey L. Front Neurol Neurology Background and Purpose: Recent noninferiority clinical trials of novel endovascular thrombectomy devices for acute ischemic stroke have used substantial reperfusion as the primary outcome of achievement. Determining the minimal clinically important difference (MCID) is an essential step for the design of noninferiority clinical trials. Materials and Methods: We surveyed international neuro-interventionalist and noninterventional vascular neurologist investigators. The questionnaire included demographic characteristics, level of clinical experience, and their MCID clinical scenario-based judgment regarding the MCID for the outcome substantial reperfusion (thrombolysis in cerebral infarction score 2b-3) within 3 passes. Results: Survey responses were received from 58 of 200 experts. Among responders, 75.9% were neuro-interventionalists (most commonly interventional neuroradiologists and interventional neurologists, followed by endovascular neurosurgeons), and 24.1% were noninterventional vascular neurologists; 87.9% had been in practice for more than 5 years, and 67.3% devoted more than half of their practice to stroke care. Responder–nonresponder and continuum of resistance analysis indicated responders were representative of the full expert population. Among experts, the median MCID for substantial reperfusion was 3.1–5% (interquartile range 1.1–3% to 5.1–10%). MCID distributions did not differ among neuro-interventionalists and noninterventional vascular neurologists. Conclusions: Neuro-interventionl and noninterventional stroke experts judged that the minimal clinically important difference in comparing thrombectomy devices for achieving substantial reperfusion is 3.1–5%. This MCID, lower than noninferiority margins used in several recent clinical trials, can inform trial designs and clinical development. Frontiers Media S.A. 2020-10-05 /pmc/articles/PMC7569750/ /pubmed/33123069 http://dx.doi.org/10.3389/fneur.2020.524220 Text en Copyright © 2020 Lin and Saver. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Neurology Lin, Chun-Jen Saver, Jeffrey L. The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment |
title | The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment |
title_full | The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment |
title_fullStr | The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment |
title_full_unstemmed | The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment |
title_short | The Minimal Clinically Important Difference for Achievement of Substantial Reperfusion With Endovascular Thrombectomy Devices in Acute Ischemic Stroke Treatment |
title_sort | minimal clinically important difference for achievement of substantial reperfusion with endovascular thrombectomy devices in acute ischemic stroke treatment |
topic | Neurology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7569750/ https://www.ncbi.nlm.nih.gov/pubmed/33123069 http://dx.doi.org/10.3389/fneur.2020.524220 |
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