Detection of Usability Errors of a Medical Device Zeneo®

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Detection of Usability Errors of a Medical Device Zeneo®

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: using the demo version of a self-injector pen


Participation Criteria
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Eligibility Criteria
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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: Able to use the device Without previous experience of anaphylactic shock Not taking a psychotropic drug Without hearing impairment Covered by social security Who signed the consent form and the information letter Who agree to conform to the procedure of the study - Exclusion Criteria: Pregnant women Vulnerable Persons Persons under administrative supervision Persons who are subject to a judicial protection measure Persons who do not understand correctly French.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 profiles of participants (naïves vs. informed) x 2 types of test environment (realistic vs. laboratory-like). Each participant, depending on her/his profile is assigned to one profile of participant group and randomly to one type of test environment group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: naive/realistic environment<br>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<br>* 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.<br>|
| Experimental: informed/realistic environment<br>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<br>* 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.<br>|
| Experimental: informed/laboratory-like environment<br>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<br>* 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.<br>|
| Experimental: naive/laboratory-like environment<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |