What is it?
The IMI GetReal consortium has drawn up definitions of key terms used in the development and assessment of real-world evidence. The main aim has been to provide clarity to GetReal researchers, but it may also be helpful for the wider community. Many of these terms have been used in different ways by different groups of stakeholders.
The glossary was drawn up by a GetReal glossary working group (Work package 1). The glossary entries have been reviewed by GetReal members and through public consultation with external stakeholders. The public consultation included open review through social media channels (for example, LinkedIn), as well as actively approaching relevant external stakeholders.
The glossary gives an overview of ‘real-world data’, and describes the origin of key concepts associated with it. It also contains a detailed explanation of the terms ‘efficacy’ and ’relative efficacy’, and ‘effectiveness’ and ‘relative effectiveness’, and how efficacy studies can be distinguished from effectiveness (pragmatic) studies.
There is some debate around the definitions of many of these terms, and in some cases no clear consensus has been reached in the international healthcare evaluation community. However, the glossary describes the definitions agreed for the GetReal project.
Amr Makady and Wim Goettsch, Zorginstituut Nederland (ZIN)