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Creating and using real-world evidence to answer questions about clinical effectiveness

de Lusignan, S and Crawford, L (2015) Creating and using real-world evidence to answer questions about clinical effectiveness J Innov Health Inform., 22 (3). pp. 368-373.

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Abstract

New forms of evidence are needed to complement evidence generated from randomised controlled trials (RCTs). Real-World Evidence (RWE) is a potential new form of evidence, but remains undefined. This paper sets to fill that gap by defining RWE as the output from a rigorous research process which: (1) includes a clear a priori statement of a hypothesis to be tested or research question to be answered; (2) defines the data sources that will be used and critically appraises their strengths and weaknesses; and (3) applies appropriate methods, including advanced analytics. These elements should be set out in advance of the study commencing, ideally in a published protocol. The strengths of RWE studies are that they are more inclusive than RCTs and can enable an evidence base to be developed around real-world effectiveness and to start to address the complications of managing other real-world problems such as multimorbidity. Computerised medical record systems and big data provide a rich source of data for RWE studies. However, guidance is needed to help assess the rigour of RWE studies so that the strength of recommendations based on their output can be determined. Additionally, RWE advanced analytics methods need better categorisation and validation. We predict that the core role of RCTs will shift towards assessing safety and achieving regulatory compliance. RWE studies, notwithstanding their limitations, may become established as the best vehicle to assess efficacy.

Item Type: Article
Subjects : Health informantics
Divisions : Faculty of Health and Medical Sciences
Authors :
AuthorsEmailORCID
de Lusignan, SUNSPECIFIEDUNSPECIFIED
Crawford, LUNSPECIFIEDUNSPECIFIED
Date : 4 November 2015
Identification Number : 10.14236/jhi.v22i3.177
Copyright Disclaimer : Published by BCS, The Chartered Institute for IT under Creative Commons license http://creativecommons.org/licenses/by/4.0/
Additional Information : Copyright © 2015 The Author(s). Published by BCS, The Chartered Institute for IT under Creative Commons license http://creativecommons.org/ licenses/by/4.0/
Depositing User : Symplectic Elements
Date Deposited : 09 Feb 2016 11:09
Last Modified : 09 Feb 2016 11:22
URI: http://epubs.surrey.ac.uk/id/eprint/809829

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