Healthy Volunteers
Conditions
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.
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.
Interventions
OTHERusing 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.
Sponsors
University Hospital, Lille
National Research Agency, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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: * 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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORRomaric Marcilly, PhD
University Hospital, Lille
Outcome results
None listed