Health literacy has not historically been framed as a human factors issue, but perhaps it should be. That’s because health literacy plays a role as a driver of behavior in all three facets of human factors – the people, tools, and environment. In fact, human factors are one of the most consequential aspects upon which efficient, positive outcomes are riding.

Consider when a person must self-inject a medication.

This task requires the patient to read the injection device’s instructions for use and then self-administer the medication. The patient’s numeracy and literacy skills, and the effectiveness of the written instructions, will either help or hinder the patient’s ability to carry out the task.

Now, imagine that a statistically significant portion of people incorrectly administer the medication. Suppose that they do not inject for a required ten seconds. The reasons why this may happen are not all equal. For instance, a person might not inject for the required ten seconds because:

• They do not understand the instructions

• The needle malfunctions

The second reason is arguably more severe than the first.

While the fix for unclear instructions may be a straightforward plain-language re-write, the solution for a needle malfuction may require a device redesign. Simply counting the number of times that the injection duration was less than the required ten seconds is an empirical data point that does not provide enough insight on its own.

Did the person not stick to the ten seconds because they didn’t understand the instructions? Were they unable to translate the instructions into action? Did they simply use the device incorrectly? Was it some combination of all three, or was it something else entirely?

The field of human factors is growing increasingly important and complicated as combination products become more common. Manufacturers face many challenges as they try to distinguish between device issues and drug issues. Traditional observation and interview techniques don’t always paint a clear picture. Qualitative methods and ergonomics can both reveal what is happening, but the role of formative research is to answer why it is happening.

Looking at it through the lens of health literacy research can help, either by identifying the underlying cause of an observed behavior as a health literacy issue, or definitively ruling it out.


Bill Stone

Director, Content Strategy