Human Factors In Medical Device Studies: Understanding The Impact Of Post-Pandemic Literacy Decline In Children And Adolescents

By Jessica Sanford, Ph.D., Senior Human Factors Engineer

The COVID-19 pandemic has significantly impacted education, resulting in a notable decline in literacy rates among children and adolescents. This decline is reflected in reading test scores and national assessments, raising concerns about long-term effects and disproportionate impacts on vulnerable groups. These literacy challenges have important implications for human factors studies, especially in the context of medical device usability.

Involving individuals with impaired reading levels, particularly children and adolescents, in these studies could lead to difficulties or errors in device usage. This may result in excluding these groups as approved users of medical devices. To address this issue, conducting literacy pre-assessments at the start of a study is recommended. These assessments can determine participants' reading levels and inform the research team of potential impacts on task outcomes.

Additionally, adjusting the writing level of device labeling to accommodate lower reading levels in the younger population may be necessary. This proactive approach can help researchers anticipate and mitigate potential issues, ensuring the inclusion of younger populations in medical device studies.

By acknowledging the decline in reading levels and implementing appropriate measures, researchers can overcome barriers and ensure the successful participation of all individuals in medical device studies.