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.
After welcoming all delegates, Prof Dipak Kotecha (ESC, University of Birmingham) provided a brief overview of the BigData@Heart project and highlighted the aim of this preliminary meeting: understanding the perspectives of different stakeholders on the challenges and opportunities of electronic health record (EHR) coded data.
The virtual floor was given to Prof Stephan Achenbach (ESC), Dr Rupa Sarkar (Lancet Digital Health) and Dr Xavier Kurz (EMA), who introduced the professional & guidelines perspective, the journal editor perspective and the regulator perspective respectively.
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 – to discuss criticalities, such as data validation, quality, coding standards, minimum standards for publications, limitations in clinical trials, coding and reimbursement, GDPR and inform consent process, and possible solutions.
The main discussion points per each breakout were summarised by Dr Angela Wood (University of Cambridge) and Dr Maureen Cronin (Vifor Pharma) in a plenary session.
Prof Folkert Asselbergs (ESC, UCL/UMCU) and Prof Dipak Kotecha (ESC, University of Birmingham) concluded the meeting inviting delegates to a follow-up event on October 26th, 2020 to be held at the European Heart Agency in Brussels.
The October meeting will focus on the social licence needed to use real world data for clinical trials, guidelines, and regulatory purposes. It will also cover ethic, privacy, and the patient perspective, as well as algorithms and the black box phenomenon.
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.
For further information, please visit https://www.escardio.org/Research/Big-Data-Heart/bigdata-heart-stakeholder-event