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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02847-46 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| National Research Agency, France | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| naive/realistic environment | Experimental | 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". |
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| informed/realistic environment | Experimental | 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". |
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| informed/laboratory-like environment | Experimental | 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". |
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| naive/laboratory-like environment | Experimental | 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". |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| using the demo version of a self-injector pen | Other | 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. |
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Romaric Marcilly, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Usability Lab of CIC IT 1403 | Lille | Haut de France | 59037 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35031090 | Result | Caron A, Vandewalle V, Marcilly R, Rochat J, Dervaux B. The Optimal Sample Size for Usability Testing, From the Manufacturer's Perspective: A Value-of-Information Approach. Value Health. 2022 Jan;25(1):116-124. doi: 10.1016/j.jval.2021.07.010. Epub 2021 Aug 28. |
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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.
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| number of unanticipated errors detected | through study completion, an average of 6 months |