Cardiovascular health technology assessment: recommendations to improve the quality of evidence

Berry, C. , Corcoran, D. and Mangion, K. (2019) Cardiovascular health technology assessment: recommendations to improve the quality of evidence. Open Heart, 6(1), e000930. (doi: 10.1136/openhrt-2018-000930) (PMID:30997126) (PMCID:PMC6443128)

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Abstract

The aim of this article is to review the role of Health Technology Assessment (HTA) organisations in appraising and recommending innovative cardiovascular technologies. We consider how bias impairs the quality of evidence from clinical trials involving cardiovascular healthcare technologies. Finally, we provide recommendations to HTA organisations to take account of bias when making guideline recommendations. Clinical research studies of medical devices, diagnostics and interventions in cardiovascular healthcare are susceptible to impairment through bias. While HTA organisations, such as the National Institute of Health and Care Excellence, may require reviewers to take account of bias, there are uncertainties as to how this is achieved, especially in cardiovascular technology trials. This becomes more relevant given that large trials are few in number; therefore, the quality of evidence from an individual trial may have a large bearing on guideline recommendations and clinical practice. HTA organisations should drive improvements in the design and rigour of randomised trials. The evolving landscape of cardiovascular healthcare technologies and related trials presents a challenge for HTA organisations and healthcare providers. The rapid turnover of evidence is externally relevant because the period from the trial publication to implementation of HTA guideline recommendations by healthcare providers may be prolonged, by which time new evidence may have emerged from subsequent trials. Implementation of a cardiovascular healthcare technology including be it a medical device, diagnostic or intervention may have profound implications for healthcare providers. These technologies may have high absolute costs and access may be influenced by socioeconomic and geographic factors.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Corcoran, Dr David and Mangion, Dr Kenneth and Berry, Professor Colin
Authors: Berry, C., Corcoran, D., and Mangion, K.
College/School:College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
Journal Name:Open Heart
Publisher:BMJ Publishing Group
ISSN:2053-3624
ISSN (Online):2053-3624
Published Online:27 February 2019
Copyright Holders:Copyright © 2019 The Authors
First Published:First published in Open Heart 6(1): e000930
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
628691Microvascular Dysfunction in Patients with Angina: The CE-MARC2 Microvascular SubstudyColin BerryBritish Heart Foundation (BHF)FS/14/15/30661RI CARDIOVASCULAR & MEDICAL SCIENCES
699321Myocardial strain measurements in survivors of acute ST-elevation myocardial infarction: implementation and prognostic significance of novel magnetic resonance imaging methods.Colin BerryBritish Heart Foundation (BHF)FS/15/54/31639RI CARDIOVASCULAR & MEDICAL SCIENCES
662681"First steps towards modelling myocardial infarction (a computed MI Physiome): A case-control study of novel biomechanical parameters in acute MI survivors with left ventricular dysfunction."Colin BerryBritish Heart Foundation (BHF)PG/14/64/31043RI CARDIOVASCULAR & MEDICAL SCIENCES
617771BHF centre of excellenceRhian TouyzBritish Heart Foundation (BHF)RE/13/5/30177RI CARDIOVASCULAR & MEDICAL SCIENCES