Table 3.
The usability questionnaire
| Part | Question | Measure |
|---|---|---|
| Part 1: Understanding the IFU (after phase 1) | Did you check the viewing window? | Yes/neutral/no |
| If yes, did you see a fluid in the viewing window? | ||
| Did you check the tamper-evident seal of the autoinjector? | ||
| If yes, was the tamper-evident seal intact? | ||
| Could you see on the autoinjector that the injection was made? | ||
| Did you see green plastic after using the autoinjector? | ||
| How useful where the pictures in the IFU? | Adjusted 5-point Likert scale* | |
| How clear was it how to move the autoinjector towards the site of injection? | ||
| How would you score the setup on the IFU in terms of ability to follow the handlings steps? | ||
| Part 2: Usability (after phase 1 and 2)—subject device acceptance and system ease of use | How clear was it to check that the autoinjector was ready for injection? | Adjusted 5-point Likert scale* |
| How easy or difficult was it to hold the autoinjector? | ||
| How easy or difficult was it to take the cap off? | ||
| How would you score the force needed to press on the autoinjector in order to inject? | ||
| How would you score the simplicity of the injection process? | ||
| How would you rate the audibility of the first click? | ||
| How well could you feel the first click? | ||
| How would you rate the audibility of the second click? | ||
| How well could you feel the second click? | ||
| After removing the autoinjector, how clear was it to check that the injection was fully given? | ||
| Part 3: Satisfaction (after phase 2)—overall satisfaction and willing to accept the device | Overall, how satisfied were you with the autoinjector? | Adjusted 5-point Likert scale* |
| How willing are you to use the autoinjector for your own medication? | ||
| How is your overall impression of the autoinjector? | ||
| How would you rate the overall use of the autoinjector? | ||
| How would you rate the safety feature of the autoinjector? | ||
| Would you recommend this device to (other) RA-patients? | Yes/neutral/no |
* For example: 1/very useful; 2/useful; 3/no opinion; 4/useless; 5/very useless. Positive answers: “Yes” and the two first points of the adjusted 5-point Likert scale. Neutral answers: “Neutral” or “No opinion” (not taken into account in the total number of answers). Negative answers: “No” and the two last points of the adjusted 5-point Likert scale. Positive response rate: number of positive answers out of the sum of positive and negative answers