Plain Language Summary
- Larger flanges (finger supports for pushing the plunger down).
- A larger, ridged, non-transparent cap that fits over the needle (instead of a see-through needle shield).
- New plunger supports.
- New protective tray.
- Everyone succeeded in delivering an injection properly and safely.
Introduction
Methods
Formative Studies
Formative Study 1
Formative Study 2
Formative Study 3
Formative Study 4
Validation Study
Data Analyses
Ethics
Results
Participants
HCPs | GEP-NET groupa (n = 18) | Acromegaly groupb (n = 15) | |||
---|---|---|---|---|---|
Untrained HCPs (n = 19) | Trained HCPs (n = 16) | All (n = 35) | |||
Gender | |||||
Male | 4 | 1 | 5 | 7 | 7 |
Female | 15 | 15 | 30 | 11 | 8 |
Age | |||||
18–34 | 5 | 5 | 10 | 8 | 4 |
35–60 | 13 | 11 | 24 | 6 | 7 |
60+ | 1 | 0 | 1 | 4 | 4 |
Professional title | |||||
RN | 12 | 10 | 22 | – | – |
Physician | 5 | 4 | 9 | – | – |
NP | 2 | 2 | 4 | – | – |
Injection experience | |||||
Experienced | 19 | 16 | 35 | 12 | 10 |
Inexperienced | 0 | 0 | 0 | 6 | 5 |
Experience with lanreotide autogel/depotc | |||||
Yes | 4 | 5 | 9 | 6 | 0 |
No | 15 | 11 | 26 | 12 | 15 |
Hand sized | |||||
Small | 7 | 8 | 15 | 7 | 3 |
Medium | 7 | 7 | 14 | 7 | 7 |
Large | 5 | 1 | 6 | 4 | 5 |
Handedness | |||||
Right | 18 | 13 | 31 | 15 | 12 |
Left/ambidextrous | 1 | 3 | 4 | 3 | 3 |
Formative Studies: Development of the New Syringe
Formative study | Comments during user study | Impact on design |
---|---|---|
1 | Small and simple needle cap with grids | Development of grey cap with a rubber grid material |
No needle shroud | No needle shroud will be added owing to development of needle cap | |
Curved finger flanges with heavy texture/rubber grips | Two prototypes created (mono-material and biomaterial for cover and overcap) | |
Plunger protector | Plunger protector is retained | |
Clear and relatively thin body | Body of the device will remain clear | |
Visual completion indicator on the middle of the device | Visual indicator to show dose delivery is not necessary. Retain transparent body so participant can see if dose has been delivered | |
Audible completion indicator | Audible sound was not added (implementation could be difficult and could increase the risk of misuse) | |
2 | Clear, useful and easy to find drug label | No impact on the design |
Font label on device label was too small | No design change. Font label updated and evaluated in formative study 4 | |
Clear device cover allows for visual inspection of drug integrity | Syringe body will stay transparent | |
Larger design of device cover was sturdier than currently marketed version | No impact on the design | |
Concave, ribbed thumb pad on plunger provides more stability | No impact on the design | |
Needle was easy to remove after injection | No impact on the design | |
Plunger protector with arrows is intuitive to use and remove | Plunger protector is kept with arrows | |
Plunger was too long and may be difficult for smaller hands to use | Nurses were able to inject correctly but expressed concerns about the device size; further investigation in formative study 4 | |
Rubber coating on finger flanges is not necessary | Rubber on the flanges removed | |
Would prefer to have a needle retraction mechanism | No needle shroud. Needle retraction safety system is kept | |
Overcap was difficult to remove; would prefer a “twist-and-pull” method of removal | Verify ergonomics of the overcaps in formative study 3 | |
Would prefer an audible click to signal injection is complete | Audible sound not added to the device owing to technical evaluation ruling it could increase the risk of misuse (and would be difficult to implement) | |
3 | The rubber coating would increase the perception of the quality of the device | Rubber grip is nice to have but is not a must-have |
Raise user’s attention to the importance of pressing plunger until total administration of the dose. Provide clear instructions to avoid misuse | The sentence ‘give plunger a final push to make sure you cannot depress the plunger further’ is in the current IFU and will be in the IFU of the new injection system | |
The coloured arrow would help user to remove the plunger protector | Arrows on the plunger protector are nice to have but not a must-have. No misuse was reported linked to non-coloured arrow. The user study 4 will be done without the coloured arrows to assess the necessity | |
The IFU is already clear but still fine-tuning to be made | No impact on the device design | |
The coloured device will optimise visibility and usage. Yellow is the preferred colour | Colour of the device is nice to have but is not a must-have. Following evaluation, there is a recommendation not to change the colour of the plunger | |
New device is better suited for self-injection compared to current devices | No impact on the design | |
4 | All participants succeeded in engaging the needle safety mechanism | No impact on the design |
All participants succeeded in pushing the plunger to the bottom of the syringe without breaking the plunger | No impact on the design | |
All participants succeeded in delivering a full dose | No impact on the design | |
One participant initially tried to inject without removing the plunger protector and overcap, considering the device as auto-injector | Plunger protector is replaced by a tray following a risk evaluation | |
Most participants did not initially remove the IFU from the box and indicated they would not normally refer to the IFU prior to delivering the injection | The risk is identical to the current marketed product. Modification of the drawings of the IFU | |
Some participants did not visually check that a full dose had been administered, but rather considered the tactile feedback of the plunger reaching the bottom of the syringe to be sufficient confirmation | Different ways permit confirmation that the plunger is pushed completely: transparent body and cover; tactile feedback of the plunger reaching the bottom of the syringe; indication on IFU to give a final push All participants were able to inject a full dose because the safety mechanism was activated. No impact on the device | |
Some participants initially tried to twist the overcap rather than pull | No safety issue because participants were able to remove the overcap at the end. No change on the overcap design | |
A few participants pinched the skin rather than flattening the injection site | The risk is identical to the current marketed product. Modification of the illustrations and instructions of the IFU | |
Participants did not wash hands either before or after the injection | The risk is identical to the current marketed product. Modification of the illustrations of the IFU | |
One EU participant accidentally pulled out the plunger support whilst trying to remove the needle cap | Syringe body: improvement of the interface between the proximal end of the syringe body and the tip of the plunger rod to prevent tear off |