2022
DOI: 10.1101/2022.05.24.22275434
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Systematic approach to outcome assessment from coded electronic healthcare records in the DaRe2THINK NHS-embedded randomised trial

Abstract: Background: Improving the efficiency of clinical trials is key to their continued importance in directing evidence-based patient care. Digital innovations, in particular the use of electronic healthcare records (EHR), allow for large-scale screening and follow-up of participants. However, it is critical these developments are accompanied by robust and transparent methods that can support high quality and high clinical value research. Methods: The DaRe2THINK trial includes a series of novel processes, incl… Show more

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Cited by 4 publications
(5 citation statements)
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“…Technological advances in EHR systems will help, such as the ability to retrieve EHR data on a daily basis to support clinical trials. 21 Taking advantage of the many real-world data initiatives to support new research: • Government agencies, regulators, charities, and professional bodies have initiated programmes for better use of realworld data that can support further activity and dissemination.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…Technological advances in EHR systems will help, such as the ability to retrieve EHR data on a daily basis to support clinical trials. 21 Taking advantage of the many real-world data initiatives to support new research: • Government agencies, regulators, charities, and professional bodies have initiated programmes for better use of realworld data that can support further activity and dissemination.…”
Section: Discussionmentioning
confidence: 99%
“…The stakeholder consensus meetings highlighted clarity of methods as an important concern for future research, supported by evidence that few studies provide sufficient detail to understand the research process. 26,27 The emergence of registry-based and EHRbased randomised controlled trials (NCT04700826; NCT01093404) 21,28 reinforces the imperative for improvements to define new concepts for quality research. With the development of robust analytics supported by machine learning algorithms, 29 similar approaches have already been used to support artificial intelligence in health care.…”
Section: Reviewmentioning
confidence: 99%
“…The stakeholder consensus meetings highlighted this area as a key concern for future research, supported by evidence that very few studies have provided sufficient detail to understand the research process. 24 25 The advent of registry and EHR-based randomised controlled trials 21 26 27 reinforces the imperative to see improvements in these areas, and to define new concepts for quality research. With the development of robust analytics supported by machine learning algorithms, 28 similar approaches have already been used to support artificial intelligence in healthcare.…”
Section: Discussionmentioning
confidence: 99%
“…Technological advances in EHR systems will help, such as the ability to retrieve EHR data on a daily basis to support clinical trials. 21 Taking advantage of the many real world data initiatives to support new research. Government agencies, regulators, charities and professional bodies have initiated programmes for better use of real-world data that can support further activity and dissemination.…”
Section: Ehr-based Trials Have the Potential To Generate Reliable And...mentioning
confidence: 99%
“…Application of inclusion and exclusion criteria within the electronic health record (EHR) can provide pre-screening lists, reducing time to identify appropriate participants. 6,7 This may also reduce bias by broadening recruitment to more diverse patients. Advances in artificial intelligence are not only assisting in data analytics, but could provide a method to stratify those at-risk based on individual interacting comorbidities.…”
Section: Innovations In Screening and Recruitmentmentioning
confidence: 99%