Mark Sendak, Gaurav Sirdeshmukh, Timothy Ochoa et al.
The approaches by which the machine learning and clinical research communities utilize real world data (RWD), including data captured in the electronic health record (EHR), vary dramatically. While clinical researchers cautiously use RWD for clinical investigations, ML for healthcare teams consume public datasets with minimal scrutiny to develop new algorithms. This study bridges this gap by developing and validating ML-DQA, a data quality assurance framework grounded in RWD best practices. The ML-DQA framework is applied to five ML projects across two geographies, different medical conditions, and different cohorts. A total of 2,999 quality checks and 24 quality reports were generated on RWD gathered on 247,536 patients across the five projects. Five generalizable practices emerge: all projects used a similar method to group redundant data element representations; all projects used automated utilities to build diagnosis and medication data elements; all projects used a common library of rules-based transformations; all projects used a unified approach to assign data quality checks to data elements; and all projects used a similar approach to clinical adjudication. An average of 5.8 individuals, including clinicians, data scientists, and trainees, were involved in implementing ML-DQA for each project and an average of 23.4 data elements per project were either transformed or removed in response to ML-DQA. This study demonstrates the importance role of ML-DQA in healthcare projects and provides teams a framework to conduct these essential activities.