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The ETTAA study protocol: A UK-wide observational study of 'Effective treatments for thoracic aortic aneurysm'

Sastry, P.; Hughes, V.; Hayes, P.; Vallabhaneni, S. R.; Sharples, L.; Thompson, M.; Catarino, P.; Moorjani, N.; Vale, L.; Gray, J.; Cook, A.; Elefteriades, J.; Large, S. R.; on behalf of the ETTAA collaborators

Authors

P. Sastry

V. Hughes

P. Hayes

S. R. Vallabhaneni

L. Sharples

M. Thompson

P. Catarino

N. Moorjani

L. Vale

J. Gray

A. Cook

J. Elefteriades

S. R. Large

on behalf of the ETTAA collaborators



Contributors

Ian Chetter
Other

Abstract

© 2015 BMJ Open. Introduction: Chronic thoracic aortic aneurysm (CTAA) affecting the arch or descending aorta is an indolent but life-threatening condition with a rising prevalence as the UK population ages. Treatment may be in the form of open surgical repair (OSR) surgery, endovascular stent grafting (ESG) or best medical therapy (BMT). Currently, there is no consensus on the best management strategy, and no UK-specific economic studies that assess outcomes beyond the chosen procedure, but this is required in the context of greater demand for treatment and limited National Health Service (NHS) resources. Methods and analysis: This is a prospective, multicentre observational study with statistical and economic modelling of patients with CTAA affecting the arch or descending aorta. We aim to gain an understanding of how treatments are currently chosen, and to determine the clinical effectiveness and cost-effectiveness of the three available treatment strategies (BMT, ESG and OSR). This will be achieved by: (1) following consecutive patients who are referred to the teams orating in this proposal and collecting data regarding quality of life (QoL), medical events and hospital stays over a maximum of 5 years; (2) statistical analysis of the comparative effectiveness of the three treatments; and (3) economic modelling of the comparative costeffectiveness of the three treatments. Primary study outcomes are: aneurysm growth, QoL, freedom from reintervention, freedom from death or permanent neurological injury, incremental cost per qualityadjusted life year gained. Ethics and dissemination: The study will generate an evidence base to guide patients and clinicians to determine the indications and timing of treatment, as well as informing healthcare decision-makers about which treatments the NHS should provide. The study has achieved ethical approval and will be disseminated primarily in the form of a Health Technology Assessment monograph at its completion. Trial registration number: ISRCTN04044627.

Citation

Sastry, P., Hughes, V., Hayes, P., Vallabhaneni, S. R., Sharples, L., Thompson, M., …on behalf of the ETTAA collaborators, . (2015). The ETTAA study protocol: A UK-wide observational study of 'Effective treatments for thoracic aortic aneurysm'. BMJ open, 5(6), e008147-e008147. https://doi.org/10.1136/bmjopen-2015-008147

Journal Article Type Article
Acceptance Date May 7, 2015
Online Publication Date Jun 2, 2015
Publication Date Jun 2, 2015
Publicly Available Date Dec 8, 2017
Journal BMJ Open
Print ISSN 2044-6055
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 5
Issue 6
Article Number e008147
Pages e008147-e008147
DOI https://doi.org/10.1136/bmjopen-2015-008147
Public URL https://hull-repository.worktribe.com/output/432716
Copyright Statement This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Copyright Statement
This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/



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