Use of the ADAPTABLE Trial to Strengthen Methods to collect and Integrate Patient-reported Information with Other Data Sets and Assess Its Validity

Using the ADAPTABLE Trial to generating tools and data standards for PCOR researchers.
Agency
  • National Institutes of Health (NIH) 
Start Date
  • 8/31/2016

 

Functionality
  • Standardized Collection of Standardized Clinical Data
  • Collection of Participant-Provided Information
  • Linking of Clinical and Other Data for Research
  • Use of Clinical Data for Research

 

STATUS: Active Project

BACKGROUND

The ADAPTABLE (Aspirin Dosing: A Patient‑centric Trial Assessing Benefits and Long‑Term Effectiveness) trial is the first major randomized comparative effectiveness trial to be conducted by the National Patient‑Clinical Research Network (PCORnet). This pragmatic clinical trial will compare the efficacy and safety of two different daily doses of aspirin widely used for patients with chronic cardiovascular disease. The ADAPTABLE trial encompasses several key features, including enrollment of 20,000 patients across six large health care systems; an internet portal to consent patients and collect patient‑reported information regarding risk factors, medications, and experiences; and reliance on existing EHR data sources for baseline characteristics and outcomes follow‑up.

PROJECT PURPOSE & GOALS

This project is spearheaded by the National Institutes of Health (NIH). Given that ADAPTABLE will rely 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 the EHR. The project will generate tools and data standards that could be deployed in other PCOR studies beyond the ADAPTABLE trial.

The project objectives are to:

  • Develop, test, and validate meta‑data standards for patient‑reported information to streamline data capture and to describe the completeness, consistency, and fitness‑for‑use of patient‑reported data in EHR research.

  • Evaluate the validity of patient reported data through systemic comparison with EHR data. The project will develop a Patient‑Reported Data Assessment Tool to quickly and efficiently evaluate concordance of patient‑reported data and EHR data.

  • Develop approaches to resolve inconsistencies between patient‑reported data and EHR‑derived data.

  • Facilitate enrollment in study‑specific target populations within larger health systems.