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Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid
INTRODUCTION: Overall, intra-arterial treatment (IAT) proved to be beneficial in patients with acute ischaemic stroke due to a proximal occlusion in the anterior circulation. However, heterogeneity in treatment benefit may be relevant for personalised clinical decision-making. Our aim is to improve...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5372176/ https://www.ncbi.nlm.nih.gov/pubmed/28336740 http://dx.doi.org/10.1136/bmjopen-2016-013699 |
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author | Mulder, Maxim J H L Venema, Esmee Roozenbeek, Bob Broderick, Joseph P Yeatts, Sharon D Khatri, Pooja Berkhemer, Olvert A Roos, Yvo B W E M Majoie, Charles B L M van Oostenbrugge, Robert J van Zwam, Wim H van der Lugt, Aad Steyerberg, Ewout W Dippel, Diederik W J Lingsma, Hester F |
author_facet | Mulder, Maxim J H L Venema, Esmee Roozenbeek, Bob Broderick, Joseph P Yeatts, Sharon D Khatri, Pooja Berkhemer, Olvert A Roos, Yvo B W E M Majoie, Charles B L M van Oostenbrugge, Robert J van Zwam, Wim H van der Lugt, Aad Steyerberg, Ewout W Dippel, Diederik W J Lingsma, Hester F |
author_sort | Mulder, Maxim J H L |
collection | PubMed |
description | INTRODUCTION: Overall, intra-arterial treatment (IAT) proved to be beneficial in patients with acute ischaemic stroke due to a proximal occlusion in the anterior circulation. However, heterogeneity in treatment benefit may be relevant for personalised clinical decision-making. Our aim is to improve selection of patients for IAT by predicting individual treatment benefit or harm. METHODS AND ANALYSIS: We will use data collected in the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) trial to analyse the effect of baseline characteristics on outcome and treatment effect. A multivariable proportional odds model with interaction terms will be developed to predict the outcome for each individual patient, both with and without IAT. Model performance will be expressed as discrimination and calibration, after bootstrap resampling and shrinkage of regression coefficients, to correct for optimism. External validation will be conducted on data of patients in the Interventional Management of Stroke III trial (IMS III). Primary outcome will be the modified Rankin Scale (mRS) at 90 days after stroke. ETHICS AND DISSEMINATION: The proposed study will provide an internationally applicable clinical decision aid for IAT. Findings will be disseminated widely through peer-reviewed publications, conference presentations and in an online web application tool. Formal ethical approval was not required as primary data were already collected. TRIAL REGISTRATION NUMBERS: ISRCTN10888758; Post-results and NCT00359424; Post-resultsc. |
format | Online Article Text |
id | pubmed-5372176 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-53721762017-04-12 Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid Mulder, Maxim J H L Venema, Esmee Roozenbeek, Bob Broderick, Joseph P Yeatts, Sharon D Khatri, Pooja Berkhemer, Olvert A Roos, Yvo B W E M Majoie, Charles B L M van Oostenbrugge, Robert J van Zwam, Wim H van der Lugt, Aad Steyerberg, Ewout W Dippel, Diederik W J Lingsma, Hester F BMJ Open Neurology INTRODUCTION: Overall, intra-arterial treatment (IAT) proved to be beneficial in patients with acute ischaemic stroke due to a proximal occlusion in the anterior circulation. However, heterogeneity in treatment benefit may be relevant for personalised clinical decision-making. Our aim is to improve selection of patients for IAT by predicting individual treatment benefit or harm. METHODS AND ANALYSIS: We will use data collected in the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) trial to analyse the effect of baseline characteristics on outcome and treatment effect. A multivariable proportional odds model with interaction terms will be developed to predict the outcome for each individual patient, both with and without IAT. Model performance will be expressed as discrimination and calibration, after bootstrap resampling and shrinkage of regression coefficients, to correct for optimism. External validation will be conducted on data of patients in the Interventional Management of Stroke III trial (IMS III). Primary outcome will be the modified Rankin Scale (mRS) at 90 days after stroke. ETHICS AND DISSEMINATION: The proposed study will provide an internationally applicable clinical decision aid for IAT. Findings will be disseminated widely through peer-reviewed publications, conference presentations and in an online web application tool. Formal ethical approval was not required as primary data were already collected. TRIAL REGISTRATION NUMBERS: ISRCTN10888758; Post-results and NCT00359424; Post-resultsc. BMJ Publishing Group 2017-03-22 /pmc/articles/PMC5372176/ /pubmed/28336740 http://dx.doi.org/10.1136/bmjopen-2016-013699 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Neurology Mulder, Maxim J H L Venema, Esmee Roozenbeek, Bob Broderick, Joseph P Yeatts, Sharon D Khatri, Pooja Berkhemer, Olvert A Roos, Yvo B W E M Majoie, Charles B L M van Oostenbrugge, Robert J van Zwam, Wim H van der Lugt, Aad Steyerberg, Ewout W Dippel, Diederik W J Lingsma, Hester F Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid |
title | Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid |
title_full | Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid |
title_fullStr | Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid |
title_full_unstemmed | Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid |
title_short | Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid |
title_sort | towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid |
topic | Neurology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5372176/ https://www.ncbi.nlm.nih.gov/pubmed/28336740 http://dx.doi.org/10.1136/bmjopen-2016-013699 |
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