Validating a Framework for Coding Patient-Reported Health Information to the Medical Dictionary for Regulatory Activities Terminology: An Evaluative Study.

PatientsLikeMe MedDRA coding of PGHD was generally comparable to how the FDA would code similar data, applying the MTS:PTC principles. Discordant coding resulted from several reasons but mostly reflected a difference in purpose. The MTS:PTC coding principles aim to capture the most specific reported information about an ADE, whereas PatientsLikeMe may code patient-reported symptoms and ADEs to more general MedDRA terms to support patient engagement among a larger group of patients. This study demonstrates that most verbatim reports of symptoms and ADEs collected by a PGHD source, such as the PatientsLikeMe platform, could be reliably coded to MedDRA terminology by applying the MTS:PTC guide. Regarding all secondary use of novel data, understanding coding and standardization principles applied to these data types are important.