A new report in the Living Textbook describes results of a literature review of data standards and metadata standards for variables of interest to the ADAPTABLE trial. Based on the review, the authors recommend standards for ADAPTABLE, also known as the Aspirin Study, which is the first major randomized comparative effectiveness trial to be conducted by the National Patient-Centered Clinical Research Network (PCORnet). The trial aims to identify the optimal dose of aspirin therapy for secondary prevention in atherosclerotic cardiovascular disease.
Because the ADAPTABLE trial relies on patients to report key information at baseline and throughout follow-up, it represents a unique opportunity to develop, pilot, and evaluate methods to validate and integrate patient-reported information with data obtained from electronic health records (EHRs). In 2016, the National Institutes of Health implemented a project with the goal of using the ADAPTABLE study to develop methods to (1) assess the quality of patient-reported data and (2) integrate the data with existing EHR data. It is hoped that this project will inform future efforts to synthesize potentially inconsistent data from patient-reported and EHR sources and identify opportunities to streamline data.