A new report from an NIH Collaboratory roundtable discussion held in 2017 discusses considerations for the capture of patient-reported health (PRH) data in clinical trials. The report is part of an effort by the ADAPTABLE Supplement project team “to address best practices for capturing PRH data in pragmatic studies and optimal analytic approaches for integrating PRH with other data sources.”

The statement was published online ahead of print this month in Healthcare.

The new consensus statement is the second report from the ADAPTABLE roundtable. A statement published in February offered guidance for the analysis and integration of PRH data in clinical trials.

ADAPTABLE, the first major randomized comparative effectiveness trial conducted by the National Patient-Centered Clinical Research Network (PCORnet), seeks to determine the optimal dose of aspirin therapy for secondary prevention of atherosclerotic cardiovascular disease. The trial relies on both existing EHR data sources and PRH data.

This work was supported by a supplemental grant award to the NIH Collaboratory Coordinating Center from the National Center for Complementary and Integrative Health.