Background: During severe hypoglycemic episodes, people with diabetes depend on others to help with treatment. We compared needle-free nasal glucagon and commercially available injectable glucagon for ease of use by caregivers of people with diabetes and by others in treating simulated episodes of severe hypoglycemia.Methods: Sixteen instructed caregivers and 15 noninstructed acquaintances administered nasal and injectable glucagon to manikins, simulating unconscious people with diabetes during severe hypoglycemia episodes.Results: With nasal glucagon, 15 caregivers (94%) and 14 acquaintances (93%) administered a full dose (mean time 0.27 and 0.44 min, respectively). One caregiver and one acquaintance did not administer nasal glucagon because they did not fully depress the plunger on the device. Two caregivers deliberately administered both insulin and nasal glucagon, believing that insulin would also help the patient. With injectable glucagon, eight caregivers (50%) injected glucagon (mean time 1.89 min), but only two (13%) administered the full dose. Three acquaintances (20%) injected a partial dose of injectable glucagon (mean time 2.40 min); none gave a full dose. Errors included injecting diluent only, bending the needle, and injecting with an empty syringe. Two caregivers and one acquaintance injected insulin because they confused insulin with injectable glucagon.Conclusions: More than 90% of participants delivered full doses of nasal glucagon, while 13% and 0% of caregivers and acquaintances delivered full doses of injectable glucagon, indicating that nasal glucagon is easier for nonmedically trained people to administer. Thus, nasal glucagon has the potential to substantially improve treatment for patients experiencing a life-threatening episode of severe hypoglycemia.
Seemingly trivial decisions like where in a waiting room to place monitors can be informed by careful data collection and the consequences can observably impact communication between hospital staff and family members waiting for loved ones in surgery.
RATIONALE: Anaphylaxis in infants and young children is increasing. Currently available epinephrine auto-injectors (EAIs) are not FDA approved for patients weighing <15 kg, and therefore, EAIs are prescribed off-label for these patients. Ultrasound studies suggest currently marketed 0.15 mg EAIs have needle lengths that may strike bone in ;29-43% of patients weighing <15 kg, resulting in possible intraosseous injection. An EAI with a shorter needle length has been developed to help potentially minimize the risk of striking bone during epinephrine injection in patients weighing 7.5 to 15 kg. A human factors usability study was completed to validate the 0.1 mg EAI user interface. METHODS: This study was conducted with parents of severely allergic children to evaluate simulated use of the 0.1 mg EAI by the intended user group. Fifteen participants were enrolled and received training on the 0.1 mg EAI. Approximately 24-hours later, participants completed a simulated emergency-use scenario using the 0.1 mg EAI with an infant mannequin. The primary endpoint was successful simulated administration of a meaningful epinephrine dose. RESULTS: All participants simulated administration of a meaningful epinephrine dose. Fourteen participants successfully used the 0.1 mg EAI per the instructions for use in the simulated emergency-use scenario. One participant did not press the device against the thigh for the length of time defined for this critical task; however, the device was pressed long enough for complete delivery of the 0.1 mg dose. CONCLUSIONS: This study validated the user interface of the 0.1 mg EAI for the intended users, uses, and use environments.
Errors made by injection-experienced and injection-inexperienced participants were compared to test whether injection experience relates to use errors among potential users of a new injection device. In our sample, healthcare professionals (Group 1) made the fewest errors overall while there was also a trend for injection-experienced laypeople (Group 2) to make more errors than injection-inexperienced laypeople (Group 3). Furthermore, the types of errors made by each of the two layperson groups appear distinct from each other, with the pattern of errors made by injection-experienced laypeople more closely resembling the pattern among medical professionals. We speculate that medically experienced laypeople might inherit the "worst of both worlds" in that, as laypeople, they make errors due to inexperience with medical procedures and that also, like healthcare professionals, they make errors due to negative transfer from past experience with medical procedures. We suggest that experienced laypeople require special consideration as a potentially vulnerable user group.
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