| アブストラクト | 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. |
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| ジャーナル名 | European heart journal. Digital health |
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| 投稿日 | 2023/1/31 |
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| 投稿者 | Wang, Xiaoxia; Mobley, Alastair R; Tica, Otilia; Okoth, Kelvin; Ghosh, Rebecca E; Myles, Puja; Williams, Tim; Haynes, Sandra; Nirantharakumar, Krishnarajah; Shukla, David; Kotecha, Dipak |
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| 組織名 | Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.;Health Data Research UK Midlands, Queen Elizabeth Hospital, University Hospitals;Birmingham NHS Foundation Trust, Birmingham, UK.;Institute of Applied Health Sciences, University of Birmingham, Birmingham, UK.;Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory;Agency, London, UK.;Patient and Public Involvement team, Birmingham, UK.;Primary Care Clinical Research, NIHR Clinical Research Network West Midlands,;Birmingham, UK. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36712153/ |
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