Summative study of an injection device
and accompanied instructions
Imagine you are long-term client interested in a series of studies aimed at evaluating an injection device and its accompanying instructions. How would you expand usability testing of a target populations to include minors for summative study?
Research continued:
This study drew upon previous work done with the same pre-filled syringe and it’s instructions. I was a moderator working with 2 senior researchers and 3 junior researchers.
We started from the pre-existing test plan, recruitment screener, moderator’s guide, and IRB forms from the previous study for efficiency.
I spent two weeks creating the test plan, recruitment screener, moderator’s guide, and submitting IRB forms. The initial tasks had been based on the previous formative studies and no significant changes were needed. With the addition of the minor group though, the Institutional Review Board (IRB) was utilized.
The proprietary pre-filled syringes were required to be refrigerated and accounted for at all times, including used devices. Inventory control procedures were put in place before testing and monitored daily.
In-person testing:
Participants
A market research firm in Orlando, FL was used to recruit 38 participants. I put together a screener to identify potential participants that would potentially be prescribed the medication for four groups:
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patients with injection experience,
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patients without injection experience,
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caregivers, and
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minors.
Setup
Sessions comprised of In-Depth Interviews (IDIs) with an introduction, simulated-use tasks, root cause probing, scripted questions, and dismissal. They were in-person, lasting 1.5 hours, with up to 5 participants scheduled per day for the course of a week.
For the simulated-use task participants were given the packaged product and asked to administer the medication using an injection pad. Two pre-filled syringes were in each package and to give a full dose, both syringes needed to be used.
After completing the simulated-use tasks, participants were asked about their understanding of the product during root cause probing. Then they were asked pre-scripted questions about the instructions and where information could be found.
Identifying trends:
Throughout testing, a running total of task performance trends and use errors was maintained for daily debrief sessions.
A comprehensive validation format report, including session videos and additional data, was delivered to the client two weeks after testing, including:
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root cause analysis table (including task analysis with PCA),
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quotes, and
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data visualizations.
This was followed by a presentation to ensure clarity and address any concerns.
Key findings:
Following the previous iterations of studies regarding this product, few critical modifications were identified.
For one participant, an image depicting the injection site did not convey essential information because the stomach was interpreted as being the person’s side. The image was changed to enhance clarity.
For a few cases, the instructions failed to adequately communicate the need for two injections. A recommendation was made to relocate the 'repeat injection' instruction earlier in the process.
