AMIA questions EHR data's role in clinical research

While EHRs collect and handle troves of data, they may not be configured to lend that data to research, according to the American Medical Informatics Association.

In comments to the FDA on a draft guidance regarding the use of EHR data in clinical investigations, the AMIA questions the quality and integrity of data in EHRs, saying its purpose is for clinical care instead of research, and as such, values across EHRs are not standardized.

"For example, blood pressure recordings in the context of randomized controlled trials usually have a strict protocol for how values should be taken, time between checks, position of the patient, cuff type, etc. In EHRs, most BPs are recorded in the same field no matter how, when, where or by whom they were recorded," according to the AMIA's letter. "This lack of standardization will be a tremendous challenge for high-quality, rigorous research."

Instead of drawing data from EHRs for clinical trials, the AMIA suggests the FDA consider data warehouses that use a common data model that support interoperability and maintain data integrity as required for clinical trials instead of the "EHR default data model."

Additionally, the AMIA writes the ONC's Health IT Certification Program unsuccessfully tries to ensure data collected by EHRs is of adequate integrity for clinical trials. The organization says requiring specifications in technology doesn't to enough to protect data quality.

"Such integrity and reliability is generally the result of the policies, procedures and actions of the EHR users rather than the technology itself, and we see this guidance overstating the ability of certification to deliver clinical investigation-quality data as a byproduct of care delivery," according to the letter.

However, the AMIA says it is "less concerned" about EHRs' role in observational studies, and using data in such studies may help the agency figure out how it can leverage this data in other clinical investigations.

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Computer, math science workers in hospitals increased 18% to help with EHRs 
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Documentation in paper records more accurate than in EHRs, study finds 

 

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