Detection of Usability Errors of a Medical Device Zeneo®
Study Details
Study Description
Brief Summary
The research addresses the question of the number of participants needed to identify as many usability-induced errors as possible in the context of summative usability tests. The research addresses also the impact of the ecological validity of the test environment on the number of usability-induced errors uncovered.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
In order to determine how many participants must be recruited to detect 95% of the anticipated use errors, two groups of participants (naives or informed to the type of device under evaluation) will take part to usability test of a demo version of an auto injector pen in one of two test environments (realistic or laboratory-like). The combination of the 2 types of users and the two types of environment composes 4 arms.
By default, 15 participants will be recruited per arm (in conformity with usual guidelines). If, in a given group, 95% of anticipated errors are detected, no more participants will be recruited in the arm. Otherwise, 5 other participants will be recruited till the 95% threshold is reached with a maximum of 40 participants per group.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: naive/realistic environment This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
Other: using the demo version of a self-injector pen
Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
|
Experimental: informed/realistic environment This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "realistic environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
Other: using the demo version of a self-injector pen
Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
|
Experimental: informed/laboratory-like environment This arm includes included participants who are informed in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
Other: using the demo version of a self-injector pen
Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
|
Experimental: naive/laboratory-like environment This arm includes included participants who are naive in terms of self-injector pens and who have been randomly attributed to the "laboratory-like environment" condition of simulation. The intervention is "using the demo version of a self-injector pen". |
Other: using the demo version of a self-injector pen
Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
|
Outcome Measures
Primary Outcome Measures
- For each arm, number of participants needed to uncover 95% of the use errors known [through study completion, an average of 6 months]
Secondary Outcome Measures
- number of use errors uncovered per participant [through study completion, an average of 6 months]
- number of participants who detected a given error [through study completion, an average of 6 months]
- number of unanticipated errors detected [through study completion, an average of 6 months]
Eligibility Criteria
Criteria
Two types of participants (healthy people) will be recruited: participants informed about auto-injector pens (BUT NOT PATIENTS) and participants naïves on this topic.
Inclusion Criteria:
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Able to use the device
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Without previous experience of anaphylactic shock
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Not taking a psychotropic drug
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Without hearing impairment
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Covered by social security
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Who signed the consent form and the information letter
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Who agree to conform to the procedure of the study -
Exclusion Criteria:
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Pregnant women
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Vulnerable Persons
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Persons under administrative supervision
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Persons who are subject to a judicial protection measure
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Persons who do not understand correctly French.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Usability Lab of CIC IT 1403 | Lille | Haut De France | France | 59037 |
Sponsors and Collaborators
- University Hospital, Lille
- National Research Agency, France
Investigators
- Principal Investigator: Romaric Marcilly, PhD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017_16
- 2017-A02847-46