Members of the Collaboratory’s Phenotypes, Data Standards, and Data Quality Core (now the Electronic Health Records Core) have published a new article describing the informatics challenges of conducting pragmatic clinical trials (PCTs) and proposing policy and research actions to facilitate the future conduct of PCTs. Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory, appearing in the March 14 online edition of the Journal of the American Medical Informatics Association, explores four broad categories of informatics challenges that have an impact on the validity, reliability, and integrity of PCTs:
Using clinical data for research
Integrating data from heterogeneous systems
Using electronic health records to support intervention delivery or health system change
Assessing and improving data capture to define study populations and outcomes
“We believe [these challenges] are generalizable to other pragmatic trials and health systems and provide a useful starting point for discussions of the important role of informatics in PCTs.” Richesson et al., J Am Med Inform Assoc 2017
You can find extensive information and guidance on informatics for PCTs in the Living Textbook chapters Acquiring and Using Electronic Health Record Data and Electronic Health Records-based Phenotyping.