Systematic approach to outcome assessment from coded electronic healthcare records in the DaRe2THINK NHS-embedded randomized trial

Abstract

Aims: 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 (EHRs), 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 and results: The DaRe2THINK trial includes a series of novel processes, including nationwide pseudonymized pre screening of the primary-care EHR across England, digital enrolment, remote e-consent, and 'no-visit' follow up by linking all primary-and secondary-care health data with patient-reported outcomes. DaRe2THINK is a pragmatic, healthcare-embedded randomized trial testing whether earlier use of direct oral anticoagulants in patients with prior or current atrial fibrillation can prevent thromboembolic events and cognitive decline (www.birmingham.ac.uk/dare2think). This study outlines the systematic approach and methodology employed to define patient information and outcome events. This includes transparency on all medical code lists and phenotypes used in the trial across a variety of national data sources, including Clinical Practice Research Datalink Aurum (primary care), Hospital Episode Statistics (secondary care), and the Office for National Statistics (mortality). Conclusion: Co-designed by a patient and public involvement team, DaRe2THINK presents an opportunity to transform the approach to randomized trials in the setting of routine healthcare, providing high-quality evidence generation in populations representative of the community at risk.

Publication DOI: https://doi.org/10.1093/ehjdh/ztac046
Divisions: College of Health & Life Sciences > School of Psychology
College of Health & Life Sciences > Aston Institute of Health & Neurodevelopment (AIHN)
Additional Information: Funding: The DaRe2THINK trial is funded by the National Institute for Health and Care Research (NIHR130280). Medications in the trial are funded by the UK Department of Health and Social Care. The opinions expressed in this study are those of the authors and do not represent the NIHR or the UK Department of Health and Social Care Publisher Copyright: © The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
Uncontrolled Keywords: Anticoagulation,Atrial fibrillation,Coding,Electronic healthcare record,Primary care,Randomized controlled trial,Secondary care,Cardiology and Cardiovascular Medicine
Publication ISSN: 2634-3916
Last Modified: 16 May 2024 07:23
Date Deposited: 12 May 2023 15:28
Full Text Link:
Related URLs: http://www.scop ... tnerID=8YFLogxK (Scopus URL)
https://academi ... 3/3/426/6701815 (Publisher URL)
PURE Output Type: Article
Published Date: 2022-09-16
Accepted Date: 2022-08-15
Authors: Wang, Xiaoxia
Mobley, Alastair R.
Tica, Otilia
Okoth, Kelvin
Ghosh, Rebecca E.
Myles, Puja
Williams, Tim
Haynes, Sandra
Nirantharakumar, Krishnarajah
Shukla, David
Kotecha, Dipak
Beatty, Susan
Mehta, Samir
Breeze, Sophie
Lancaster, Karen
Fordyce, Stuart
Allen, Naomi
Calvert, Melanie
Denniston, Alastair
Gkoutos, George
Jayawardana, Sahan
Ball, Simon
Baigent, Colin
Brocklehurst, Peter
Lester, Will
McManus, Richard
Seri, Stefano (ORCID Profile 0000-0002-9247-8102)
Valentine, Janet
Camm, A. John
Moore, Dame Julie
Rogers, Amy
Stanbury, Mary
Flather, Marcus
Walker, Suzy
Wang, Duolao

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