WorksheetsPendl Study: Discussion and Conclusion
Total questions: 9
Worksheet time: 8mins
Which of the following is true about the PENDL Study?
A. The secondary endpoints all tested superiority of the comparator PN vs the investigational BD 4mm PN
B. Needle bend was defined as being present if the bend rating was ≤ 2 (<10◦)
C. The primary endpoint of each study was to demonstrate noninferiority of the investigational BD 32 G x 4mm PN for participant-reported injection pain compared with each of the 33 G and 34 G comparator PNs.
D. The occurrence of leakage was defined as wet weight equivalent to ≤ 5% of the injection volume
E. If the primary endpoint met the noninferiority criterion of -25 mm, then the 32G PN was evaluated for superiority vs each comparator
The results of Studies 1 and 2 indicate that:
A. The investigational BD 32G x 4mm PN results in significantly less injection pain and less force to deliver the dose
B. The results are consistent with Study 1 for ethnically diverse participants and with Study 2 for participants with Japanese ethnicity
C. Leakage from the needle tip and injection site was significantly less compared with 2 of the 3 comparators (Study 1)
D. There were no significant differences in occurrence of needle bending for any PN comparisons
E. All of the choices
Which of the following statements is correct?
A. The PENDL Study was published in Current Medical Research and Opinion (CMRO) in 2020
B. The PENDL Study was published in Current Research and Medical Opinion (CRMO) in 2020
C. The PENDL Study was published in Current Medical Research and Opinion (CMRO) in 2019
D. The PENDL Study was published in Current Research and Medical Opinion (CRMO) in 2019
E. None of the choices
In conclusion, the PENDL Study demonstrated that:
A. Thinner PNs offer additional pain reduction benefit and force reduction benefit
B. BD 32G 4mm PN was associated with less participant-reported pain and less force required for dose delivery vs Insupen 33G 4mm, Comfort EZ 33G 4mm, Insupen 34G 3.5mm, and Terumo 34G 4mm PNs.
C. Shorter PNs offer additional pain reduction benefit and force reduction benefit
D. No additional pain reduction benefit or force reduction benefit by thinner PNs compared with the investigational BD 32G PN
E. Choices B and D only
Adjusted mean differences for perceived injection pain favored:
A. Terumo 34G
B. Insupen 33G
C. Insupen 34G
D. BD 32G
E. Comfort EZ 33G
Adjusted mean differences for perceived delivery force favored:
A. Terumo 34G
B. Insupen 33G
C. BD 32G
D. Insupen 34G
E. Comfort EZ 33G
Leakage rate between BD 32G PN and three comparator PNs in Study 1
A. Less frequent with BD vs 2 of 3 comparator PNs
B. More frequent with BD vs comparator PNs
C. Less frequent with BD vs 1 of 3 comparator PNs
D. More frequent with BD vs 2 of 3 comparator PNs
E. Not reported
Leakage rate between BD 32G PN and Terumo 34G PN in Study 2
A. No statistical difference
B. Statistical difference
C. Not reported
D. 0.3% for BD and 1.8% for Terumo
E. Only A and D
Which of the following statements is correct?
A. The investigational BD 32G PNs has a re-engineered design with a contoured hub and an expanded surface area vs. the comparator PNs with cylindrical posted hubs.
B. The investigational 32G PN was associated with less participant reported injection pain and less perceived dose delivery force compared with four thinner PNs
C. The investigational 32G PN met non-inferiority as well as superiority criteria for less injection pain vs. each comparator
D. The results of these studies suggest no additional pain reduction benefit or force reduction benefit conferred by the thinner PNs studied when compared with the investigational BD 32G PN.
E. All of the choices
