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 Gkoutos; Sahan 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

doi:10.1093/ehjdh/ztac046

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 journal › Article › peer-review

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.

Original language	English
Pages (from-to)	426-436
Number of pages	11
Journal	European Heart Journal - Digital Health
Volume	3
Issue number	3
DOIs	https://doi.org/10.1093/ehjdh/ztac046
Publication status	Published - 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 (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

Keywords

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

Access to Document

10.1093/ehjdh/ztac046Licence: CC BY 4.0

Systematic approach to outcome assessmen
© 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
Final published version, 2.01 MBLicence: CC BY 4.0

Cite this

Wang, X., Mobley, A. R., Tica, O., Okoth, K., Ghosh, R. E., Myles, P., Williams, T., Haynes, S., Nirantharakumar, K., Shukla, D., Kotecha, D., Beatty, S., Mehta, S., Breeze, S., Lancaster, K., Fordyce, S., Allen, N., Calvert, M., Denniston, A., ... Wang, D. (2022). Systematic approach to outcome assessment from coded electronic healthcare records in the DaRe2THINK NHS-embedded randomized trial. European Heart Journal - Digital Health, 3(3), 426-436. https://doi.org/10.1093/ehjdh/ztac046

@article{52805d69778a4c1181bac11378e8b7b1,

title = "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.",

keywords = "Anticoagulation, Atrial fibrillation, Coding, Electronic healthcare record, Primary care, Randomized controlled trial, Secondary care",

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

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: {\textcopyright} 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.",

year = "2022",

month = sep,

day = "16",

doi = "10.1093/ehjdh/ztac046",

language = "English",

volume = "3",

pages = "426--436",

number = "3",

}

Wang, X, Mobley, AR, Tica, O, Okoth, K, Ghosh, RE, Myles, P, Williams, T, Haynes, S, Nirantharakumar, K, Shukla, D, Kotecha, D, Beatty, S, Mehta, S, Breeze, S, Lancaster, K, Fordyce, S, Allen, N, Calvert, M, Denniston, A, Gkoutos, G, Jayawardana, S, Ball, S, Baigent, C, Brocklehurst, P, Lester, W, McManus, R, Seri, S, Valentine, J, Camm, AJ, Moore, DJ, Rogers, A, Stanbury, M, Flather, M, Walker, S & Wang, D 2022, 'Systematic approach to outcome assessment from coded electronic healthcare records in the DaRe2THINK NHS-embedded randomized trial', European Heart Journal - Digital Health, vol. 3, no. 3, pp. 426-436. https://doi.org/10.1093/ehjdh/ztac046

TY - JOUR

T1 - Systematic approach to outcome assessment from coded electronic healthcare records in the DaRe2THINK NHS-embedded randomized trial

AU - Wang, Xiaoxia

AU - Mobley, Alastair R.

AU - Tica, Otilia

AU - Okoth, Kelvin

AU - Ghosh, Rebecca E.

AU - Myles, Puja

AU - Williams, Tim

AU - Haynes, Sandra

AU - Nirantharakumar, Krishnarajah

AU - Shukla, David

AU - Kotecha, Dipak

AU - Beatty, Susan

AU - Mehta, Samir

AU - Breeze, Sophie

AU - Lancaster, Karen

AU - Fordyce, Stuart

AU - Allen, Naomi

AU - Calvert, Melanie

AU - Denniston, Alastair

AU - Gkoutos, George

AU - Jayawardana, Sahan

AU - Ball, Simon

AU - Baigent, Colin

AU - Brocklehurst, Peter

AU - Lester, Will

AU - McManus, Richard

AU - Seri, Stefano

AU - Valentine, Janet

AU - Camm, A. John

AU - Moore, Dame Julie

AU - Rogers, Amy

AU - Stanbury, Mary

AU - Flather, Marcus

AU - Walker, Suzy

AU - Wang, Duolao

N1 - 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.

PY - 2022/9/16

Y1 - 2022/9/16

N2 - 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.

AB - 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.

KW - Anticoagulation

KW - Atrial fibrillation

KW - Coding

KW - Electronic healthcare record

KW - Primary care

KW - Randomized controlled trial

KW - Secondary care

UR - http://www.scopus.com/inward/record.url?scp=85148470316&partnerID=8YFLogxK

UR - https://academic.oup.com/ehjdh/article/3/3/426/6701815

U2 - 10.1093/ehjdh/ztac046

DO - 10.1093/ehjdh/ztac046

M3 - Article

AN - SCOPUS:85148470316

VL - 3

SP - 426

EP - 436

JO - European Heart Journal - Digital Health

JF - European Heart Journal - Digital Health

IS - 3

ER -

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

Abstract

Bibliographical note

Keywords

Access to Document

Other files and links

Fingerprint

Cite this