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Electronic health records can contain bias, potentially impacting clinical trials

Andrew Boyd

The results of some clinical trials may not be broadly applicable if they are based on data from electronic health records, which may exclude people from underrepresented and underserved groups.

Reliance on electronic records is “almost a hidden form of bias,” explained Andrew Boyd, associate professor of biomedical and health information sciences and lead author of a commentary published in Contemporary Clinical Trials.

Embedded pragmatic clinical trials, which test the effectiveness of medical interventions in real-world settings, rely heavily on electronic health records for data. Researchers see this as a way to include more diverse participants than traditional clinical trials, which use laboratory conditions and have stricter rules about who is eligible.

However, there are two major problems with this approach, Boyd said:

  • electronic medical records don’t exist for people without access to health care, so they are entirely omitted from the studies
  • when clinical trials ask participants to self-report systems through a patient portal, some can’t fill out the questionnaires because of difficulties with internet access, language or education level.

The exclusion of these groups becomes a self-perpetuating cycle that continues to increase health inequities, Boyd said. This is especially problematic as artificial intelligence algorithms become more common in medical decision-making.

The authors of the commentary suggest researchers take extra steps to recruit participants without electronic health records or easy access to the internet. They also advise working with community groups to make sure questionnaires are understandable and reflect participants’ life experiences and identities.

Besides Boyd, authors include nursing professor Judith Schlaeger, senior author; nursing professor Crystal Patil; nursing student Juanita Darby; and biomedical health informatics doctoral candidate Jonathan Leigh.

This article has been edited for length and clarity by Sonya Booth.

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