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ESC Congress 2020 Register

BigData@Heart Stakeholder Event

7th July 2020 (14:00-16:00 CEST) – virtual meeting



With the rapid development in health data science in recent years, in particular around electronic healthcare records and associated coded outcomes, there now exists a gap between technical innovation and robust clinical evidence.  For example, the broad use of coding schemes for outcomes in both observational and randomised research that lacks any structural basis or minimum quality requirements. 

In this context, the BigData@Heart Consortium, which is a jointly funded by the EU and industry to address key unmet needs in cardiovascular data science, organised an online stakeholder meeting on July 7th, 2020 to guide future research and clinical decision support by raising awareness of current limitations and providing a framework for best practice approaches for

  1. ascertaining the quality and adequacy of coding, and
  2. integration and harmonisation. 

The event brought together regulators, journal editors, industry, funders, payers, patients and cardiology professionals within the European Society of Cardiology. 

Scientific experts and key opinion leaders were assigned to a breakout session - (1) Definitions of disease in EHRs & the need for common standards, or (2) Coding equivalence and implications for clinical trials.

The BigData@Heart online meeting will prepare the groundwork for an in-person meeting on October 26th, 2020 to be held at the European Heart Agency in Brussels (10:30 until 16:00 local time).

There will be an iterative process, so the online meeting, in person meeting and offline communications and drafts will all contribute to a final white paper.

Agenda of the Meeting

Time

Topic

14:00 to 14:15

Introductions 

[Chair: Dipak Kotecha]

14:15 to 14:45

Stakeholder perspectives – Challenges & opportunities 

  • Journal Editor perspective [Rupa Sarkar, Lancet Digital Health]
  • Regulator perspective [Xavier Kurz, EMA]
  • Professional & Guidelines perspective [Stephan Achenbach, ESC]

14:45 to 15:30

Breakouts: The landscape of contemporary real-world data evidence 

1.    Definitions of disease in EHRs & the need for common standards [Lead: Tom Lumbers; Moderator: Folkert Asselbergs; Plenary feedback: Angela Wood; Slides: Carl Steinbeißer]

  • What is the pathway from event to coding and what are the implications of the diversity of coding standards?
  • What are the challenges in terms of data validation, access, interoperability and transparency of data sources?
  • Do the pros of data linkage outweigh the cons?
  • How do we bridge the gap between the needs of different stakeholders?  

2.    Coding equivalence and implications for clinical trials

[Lead: Stefan Anker, Rick Grobbee; Moderator: Dipak Kotecha; Plenary feedback: Maureen Cronin; Slides: Cinzia Ceccarelli]

  • Do we accept clinical data from routine practice (blood pressure, weight, laboratory measurements extracted from EHR)? 
  • Do we accept adverse events collected from the EHR? How about SAEs?
  • Should publication of coding schemes be a pre-requisite for trials?  
  • What is the equivalence of EHR-outcomes compared to adjudication?
  • What is required for regulatory purposes and guideline change?

15:30 to 15:45

Plenary

[Chair: Folkert Asselbergs; Angela Wood; Maureen Cronin]

15:45 to 16:00

Planning for face-to-face meeting & intermediate work

[Chairs: Folkert Asselbergs; Dipak Kotecha]

 

Find out more about the faculty

Participants

Name

Role/Representation

Gunnar Brobert

Bayer

Andrea Derix

Bayer

Lothar Roessig

Bayer

Tiago Villanueva

British Medical Journal

Stefan Anker

Charité - Universitätsmedizin Berlin

Ceri Thompson

European Commission

Thomas Lüscher

European Heart Journal

Filippo Crea

European Heart Journal

Susanne Logstrup

European Heart Network

Marilena Vrana

European Heart Network

Xavier Kurz

European Medicines Agency

Stephan Achenbach

European Society of Cardiology

Dan Atar

European Society of Cardiology

Martin Cowie

European Society of Cardiology

Panos Vardas

European Society of Cardiology

Stephan Windecker

European Society of Cardiology

Valentina Tursini

European Society of Cardiology

Cinzia Ceccarelli

European Society of Cardiology

Ileana Piña

Food and Drug Administrations’ Center for Devices and Radiological Health

Martin Ingvar

ICHOM

Salome Koussoroplis Innovative Medicines Initiative

Adrian Jonas

National Institute for Health and Care Excellence

Wim Goettsch

Netherlands Healthcare Institute

Benoit Tyl

Servier

Carl Steinbeisser

Steinbeisser Project Management

Kees van Buchove

The Hyve

Stuart Spencer

The Lancet

Rupa Sarkar

The Lancet Digital Health

Amitava Banerjee

University College London

Tom Lumbers

University College London

Spiros Denaxas

University College London

Harry Hemingway

University College London

Folkert Asselbergs

University College London / University Medical Center Utrecht

Angela Wood

University of Cambridge

Rick Grobbee

University Medical Center Utrecht

George Gkoutos

University of Birmingham

Dipak Kotecha

University of Birmingham

Maureen Cronin

Vifor Pharma

Jen Taylor

Medical Writer