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

Xiaoxia Wang, Alastair R. Mobley, Otilia Tica, Kelvin Okoth, Rebecca E. Ghosh, Puja Myles, Tim Williams, Sandra Haynes, Krishnarajah Nirantharakumar, David Shukla, Dipak Kotecha*, Susan Beatty, Samir Mehta, Sophie Breeze, Karen Lancaster, Stuart Fordyce, Naomi Allen, Melanie Calvert, Alastair Denniston, George GkoutosSahan Jayawardana, Simon Ball, Colin Baigent, Peter Brocklehurst, Will Lester, Richard McManus, Stefano Seri, Janet Valentine, A. John Camm, Dame Julie Moore, Amy Rogers, Mary Stanbury, Marcus Flather, Suzy Walker, Duolao Wang

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


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 ( 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.

Original languageEnglish
Pages (from-to)426-436
Number of pages11
JournalEuropean Heart Journal - Digital Health
Issue number3
Publication statusPublished - 16 Sept 2022

Bibliographical note

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 (, which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.


  • Anticoagulation
  • Atrial fibrillation
  • Coding
  • Electronic healthcare record
  • Primary care
  • Randomized controlled trial
  • Secondary care


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