Global digital health leaders propose a framework for improving research using real-world data

The Lancet Digital Health (2022). DOI: 10.1016 / S2589-7500 (22) 00151-0 “width =” 800 “height =” 530 “/>

From structured health data to improving patient care Key challenges and improvement pathways leading to sustainable impact from EHR-based research studies. EHR = electronic health record. Credit: The Lancet Digital Health (2022). DOI: 10.1016 / S2589-7500 (22) 00151-0

Routinely collected health data has the potential to improve the lives and well-being of patients around the world through a better understanding of the disease and research into existing and new treatments. Presented today at the ESC Congress and contextually published in The Bmj, The Lancet Digital Health And European Journal of the Heartan international team proposes a framework for improving the integrity and quality of studies using health data and increasing confidence in using the results to support clinical decisions.

The approach was compiled by a wide range of global stakeholders, coordinated by the BigData @ Heart consortium and the European Society of Cardiology. This included patient and patient advocacy groups, regulators, government agencies, and leading medical journals, as well as representatives from professional associations, academic institutions, the pharmaceutical industry, and taxpayers. Participants came together to explore opportunities and challenges and develop pragmatic advice on how health data can be applied to research across the disease spectrum.

“Health data science has undergone rapid development in recent years, including the common adoption of electronic health record systems. However, concerns about quality, data privacy, transparency and comparability have limited use. of evidence generated using structured health data. These issues have also limited regulatory, reimbursement authorities and task forces’ acceptance of the guidelines, ”the paper said.

The author, Professor Dipak Kotecha of the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, UK, said: “With the support of patients and the public, routinely collected health information offers an exciting opportunity. to answer important clinical questions in representative populations of our communities Our ability to apply the results of studies using these data sources is critically dependent on transparency at every stage.This international framework will enable robust and effective use of health data to clinical research and will provide those working in this field with guidance on how to design better studies for maximum patient care benefit. “

The CODE-EHR framework was developed iteratively to provide researchers with step-by-step guidance on how to achieve adequate governance and transparency, and to enable stakeholders to have confidence in reported results. Minimum standards are outlined for five key areas, with preferred standards providing direction for future research:

  • Building and linking of data sets; clarify the source, completeness and linkage of all health data used in the study.
  • Data fit for purpose; providing details on the coding systems used, any data manipulations and data quality assessment.
  • Outcome and definitions of the disease; allowing other researchers to reuse and improve by clearly stating all codes and algorithms used, including those for patient identification, therapy, procedures, comorbidities and outcomes.
  • Analyses; describing how outcome events were analyzed to enable validation and replication.
  • Ethics and governance; communication processes for consent, data privacy and patient and public involvement.

The report’s author, Professor Folkert Asselbergs of University Medical Center Utrecht, The Netherlands, and University College London, UK, said: “The use of real-world data in large-scale registers and Randomized trials is ushering in a new era of clinical evidence generation. The CODE-EHR framework addresses public concerns about data sharing and provides greater clarity on the use of real-world health data for a wide range of stakeholders to improve clinical assistance “.


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More information:
Dipak Kotecha et al, CODE-EHR best practice framework for the use of structured electronic health records in clinical research, Bmj (2022). DOI: 10.1136 / bmj-2021-069048

Dipak Kotecha et al, CODE-EHR best practice framework for the use of structured electronic health records in clinical research, The Lancet Digital Health (2022). DOI: 10.1016 / S2589-7500 (22) 00151-0

Dipak Kotecha, CODE-EHR best practice framework for the use of structured electronic health records in clinical research, European Journal of the Heart (2022). DOI: 10.1093 / eurheartj / ehac426

Provided by the European Society of Cardiology

Citation: Global Digital Health Leaders Propose Framework to Improve Research Using Real World Data (2022, Aug 30) retrieved Aug 30, 2022 from https://medicalxpress.com/news/2022-08-global-digital -health-leaders-framework. html

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