TRANSFoRm project agreement signed by European Commission

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Translational Research and Patient Safety in Europe: TRANSFoRm

King’s College London are leading a consortium of 15 European Universities and two private partners to develop methods, standards and systems for the integration of healthcare computer systems for clinical care and research. The project has two aims:

  1. To aid General Practitioners in diagnosis by integrating decision support directly into their electronic records systems
  2. To speed up the recruitment, management and follow up of patients for research studies by enabling routine electronic health record systems to link to research databases.

Aim 1) Prompt diagnosis is a fundamental task for GPs, as they are in many countries the ‘gatekeepers’ to specialist care and see patients with initial symptoms. The difficulty is to identify patients with symptoms of serious disease such as cancer or heart disease without over-investigating the much larger numbers of patients without serious disease. The symptoms and signs of serious disease are often non-specific and can be attributed to more common and less serious conditions. Clinical prediction rules are combinations of symptoms and signs, sometimes using a mathematical weighting, that have higher predictive value than symptoms and signs in isolation. They are, however, hard to remember and are rarely used in daily practice. King’s College London will be studying how early diagnostic prompts and late ‘alerts’, based on clinical prediction rules, might aid diagnostic performance. King’s and Birmingham University will be developing a ‘generic’ interface to allow GPs using different record systems to use TRANSFoRm, seamlessly integrated into their existing system. The Royal College of Surgeons of Dublin will develop a means for piping new clinical prediction rules into the system using a ‘web service’ and computer ‘middleware’. The system will be studied in the UK, Ireland and Greece using a multi-channel recording tool (the Alpha Toolkit) developed at St Georges’ Hospital Medical School.

Aim 2) Translational Research is a term that refers both to the exploration of basic science discoveries in clinical work and the application of research in clinical settings. Clinical research is often costly and slow, as it is difficult to find suitable subjects and time consuming to follow them up and obtain outcome data. TRANSFoRm will enable both these activities to be achieved using routine healthcare data. Two ‘example problems’ will be tackled. The University of Antwerp, representing the European General Practice Research Network and Primary Care Diabetes Europe, and the University of Dundee will develop predictors of risk of complications of Type 2 Diabetes using a very large phenotype-genotype association study. The Karolinska Institute, representing the European Primary Care Gastroenterology Society, will study the long-term effectiveness of on-demand vs. continuous use of acid suppression in gastro-oesophageal reflux in a very large randomised trial. The TRANSFoRm system will be developed by Trinity College Dublin, the University of Birmingham, the University of Limerick, Imperial College London and King’s College London using an open source model.

There are considerable challenges to be overcome in the legal and ethical domains in relation to access of data, legal frameworks for research, models for interoperability between systems and the development of standards and sustainable models for deploying and using the work of the project. The Mediterranean Institute of Primary Care (Malta), the Medicines and Healthcare Regulatory Authority, General Practice Research Database (UK), NIVEL (Netherlands) and Language and Computing (Belgium) will assist in these areas. The University of Dusseldorf will manage project ethics and also dissemination activities via the European Clinical Research Infrastructures Network. Quintiles UK and Ireland will explore and demonstrate the role of TRANSFoRm in commercial clinical trials.

TRANSFoRm has been funded by the European Union Framework Programme 7 (Project No 247787), Information Society and Media Directorate, ICT Health Unit, to a total EU contribution of €6.95Million over 5 years, commencing 1. March 2010.