PragMagic

Pragmatic Trial resources

IMPORTANT NOTICE:

PragMagic has been updated and renamed to the GetReal Trial Tool. Please visit https://getrealtrialtool.eu/ to use the tool. Your PragMagic account details remain valid in the new tool and your project data is still available. This website will be taken offline soon.

Data collection and management Data collection in Pragmatic Trials

This paper discusses challenges that are related to the different methods of data collection and presents potential solutions where possible. No one-size-fits-all recommendation can be given for the collection of data in pragmatic trials, although in general the application of existing routinely used data collection systems and processes seem to best suit the pragmatic approach. However, data access and privacy, the time points of data collection, the level of detail in the data and the lack of a clear understanding of the data collection process were identified as main challenges for the usage of routinely collected data in pragmatic trials. A first step should be to determine to what extend existing healthcare databases provide the necessary study data and can accommodate data collection and management. When more elaborate or detailed data collection or more structured follow-up is required, data collection in a pragmatic trial will have to be tailor-made, often using a hybrid approach utilizing a dedicated electronic case report form (eCRF). In this case the eCRF should be kept as simple as possible to reduce the burden for practitioners and minimize influence on routine clinical practice.

 

Go back to data