1 Introduction

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Policy makers, researchers, healthcare professionals and many others are daily facing the challenge of how to prioritise their activities and actions in different areas of their responsibilities. In the health area, their decisions are often influenced by the reality of the needs of an aging population on the one hand and restricted resources on the other. They can only make as good informed decisions as the quality and availability of data they use in the process.

Patient registries, which were designed for patients with sharing characteristics (diagnosis, implanted device, therapy, risk of developing a disease), have for decades served as an important source of the data needed to assess clinical performance, provide health technology assessment or assess policy implications on a local, regional, national and in some cases international level. As a result, hundreds of registries have been set up, ranging from paper based spreadsheets in a physician’s office to international rare disease initiatives coupling clinical and genetic data as well as bio-banks. In the last fifteen years information technology has given us an opportunity to greatly redesign the way we make informed decisions about individual patients as well as entire populations by, among other things, enabling clinicians to collect, share, compare and analyse large amounts of patient data.

Where we still fall short is in harnessing information and new knowledge from the wealth of data across registries – be it from one country to another or between/across registries with overlapping characteristics or patient pools. Researchers, HTA organisations and policy creators are wasting valuable time acquiring data from different sources and painstakingly pairing it in order to extract new knowledge. Also, setting up a new patient registry sets the holder on a high risk journey where a number of decisions need to be made about methodologies, processes, technologies and governance of the registry with little available guidance.

To provide guidance and tools on an EU level to solve the above issues is likely to be the largest near-term opportunity towards data and information driven public health decision making, policy creation and research.

The PARENT JA team is proud to present the Guidelines, which were created to provide practical and ‘hands on’ advice to set up and manage patient registries as well as to enable secondary use of data for public health policy and research. We hope the Guidelines will make life easier for those setting up new registries or redesigning already functioning registries and those exchanging data across registries.

Getting to this point has been a challenging journey but we have made it. It is a result of the commitment and passion of a number of experts from across the EU as well as continuous support from numerous EU bodies and projects, and the US Agency for Healthcare Research and Quality – all of whom generously contributed their knowledge and insights into the topic.

While the Guidelines are a first step towards greater interoperability of patient registries, a number of exciting and complex challenges still lie ahead, requiring continuous efforts to ensure that we utilise the full value of patient registries.

May the Guidelines serve you well.