Nurse evaluation of the redesigned fertility pen injector: a questionnaire-based observational survey

References

• Merck. Periodic safety update report for follitropin alfa/gonal-f. Darmstadt, Germany: Merck KGaA. 2016.
   Google Scholar
• Gibreel A, Bhattacharya S. Recombinant follitropin alfa/lutropin alfa in fertility treatment. Biologics. 2010;4:5–17.
   PubMedGoogle Scholar
• Boivin J, Domar AD, Shapiro DB, et al. Tackling burden in ART: an integrated approach for medical staff. Hum Reprod. 2012;27(4):941–950.
   PubMed Web of Science ®Google Scholar
• Brandes M, Van Der Steen JO, Bokdam SB, et al. When and why do subfertile couples discontinue their fertility care? A longitudinal cohort study in a secondary care subfertility population. Hum Reprod. 2009;24(12):3127–3135.
   PubMed Web of Science ®Google Scholar
• Pasch LA, Holley SR, Bleil ME, et al. Addressing the needs of fertility treatment patients and their partners: are they informed of and do they receive mental health services? Fertil Steril. 2016;106(1):209–215 e202.
   PubMed Web of Science ®Google Scholar
• Schaller MA, Griesinger G, Banz-Jansen C. Women show a higher level of anxiety during IVF treatment than men and hold different concerns: a cohort study. Arch Gynecol Obstet. 2016;293(5):1137–1145.
   PubMed Web of Science ®Google Scholar
• Moura-Ramos M, Gameiro, S, Canavarro MC, et al. Does infertility history affect the emotional adjustment of couples undergoing assisted reproduction? The mediating role of the importance of parenthood. Br J Health Psychol. 2016;21:302–317.
   PubMed Web of Science ®Google Scholar
• Olivius C, Friden B, Borg G, et al. Why do couples discontinue in vitro fertilization treatment? A cohort study. Fertil Steril. 2004;81:258–261.
   PubMed Web of Science ®Google Scholar
• Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001;23(8):1296–1310.
   PubMed Web of Science ®Google Scholar
• Lee WC, Balu S, Cobden D, et al. Medication adherence and the associated health-economic impact among patients with type 2 diabetes mellitus converting to insulin pen therapy: an analysis of third-party managed care claims data. Clin Ther. 2006;28(10):1712–1725; discussion 1710–1711.
   Web of Science ®Google Scholar
• Graff MR, McClanahan MA. Assessment by patients with diabetes mellitus of two insulin pen delivery systems versus a vial and syringe. Clin Ther. 1998;20(3):486–496.
   PubMed Web of Science ®Google Scholar
• Baser O, Bouchard J, DeLuzio T, et al. Assessment of adherence and healthcare costs of insulin device (FlexPen) versus conventional vial/syringe. Adv Ther. 2010;27(2):94–104.
   PubMed Web of Science ®Google Scholar
• Buhler K. Managing infertility with the follitropin alfa prefilled pen injector – patient considerations. Ther Clin Risk Manag. 2015;11:995–1001.
   PubMed Web of Science ®Google Scholar
• Libraro JL. The evolving role of the art nurse: a contemporary review. In: Textbook of assisted reproductive techniques: clinical perspectives. David K Gardiner, Ariel Weissman, Colin Howles and Zeev Shoham (Eds). CRC Press, and imprint of the Taylor Francis Group, Florida, USA. 2012.
   Google Scholar
• Abbotts C, Salgado-Braga C, Audibert-Gros C. A redesigned follitropin alfa pen injector for infertility: results of a market research study. Patient Prefer Adherence. 2011;5:315–331.
   PubMed Web of Science ®Google Scholar
• Veronesi G, Poerio CS, Braus A, et al. Determinants of nurse satisfaction using insulin pen devices with safety needles: an exploratory factor analysis. Clin Diabetes Endocrinol. 2015;1:15.
   PubMedGoogle Scholar
• Brunton S. Initiating insulin therapy in type 2 diabetes: benefits of insulin analogs and insulin pens. Diabetes Technol Ther. 2008;10(4):247–256.
   PubMed Web of Science ®Google Scholar
• Bailey T, Campos C. FlexTouch® for the delivery of insulin: technical attributes and perception among patients and healthcare professionals. Expert Rev Med Devices. 2012;9(3):209–217.
   PubMed Web of Science ®Google Scholar
• Pfutzner A, Forst T, Niemeyer M, et al. Assessment for ease of use and preference of a new prefilled insulin pen (FlexTouch Degludec u100/u200) versus the SoloSTAR insulin pen by patients with diabetes and healthcare professionals. Expert Opin Drug Deliv. 2014;11(9):1381–1389.
   PubMed Web of Science ®Google Scholar
• Nadeau DA, Campos C, Niemeyer M, et al. Healthcare professional and patient assessment of a new prefilled insulin pen versus two widely available prefilled insulin pens for ease of use, teaching and learning. Curr Med Res Opin. 2012;28(1):3–13.
   PubMed Web of Science ®Google Scholar
• Pang SC. A pen injection device for self-administration of recombinant follicle-stimulating hormone for fertility treatments. Expert Rev Med Devices. 2005;2(1):27–32.
   PubMed Web of Science ®Google Scholar
• Procedural steps taken and scientific information after the authorisation: Pergoveris: European Medicines Agency, London. 2017. [cited 2017 Nov 28]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_steps_taken_and_scientific_information_after_authorisation/human/000714/WC500039988.pdf
   Google Scholar
• Merck receives fda approval for new gonal-f(r) prefilled pen. 2017. [cited 2017 Nov 28]. Available from: https://www.merckgroup.com/en/news/fda-approval-for-gonal-f-13-11-2017.html
   Google Scholar
• Jeannerot F, Studeli T, Gunther-LaVergne L, et al. Usability engineering study in the European Union of a redesigned follitropin alfa pen injector for infertility treatment. Expert Opin Drug Deliv. 2016;9:1–9.
   Web of Science ®Google Scholar
• Mahony M, Dwyer A, Barkume R, et al. U.S. Human factors engineering evaluation of an updated follitropin alfa pen injector (Gonal-f® RFF Redi-ject™) and instructions for use. Expert Opin Drug Deliv. 2018;15:5–15.
   PubMed Web of Science ®Google Scholar
• Jeannerot F, Cusin A, Schertz J. Dose accuracy of the redesigned follitropin alfa pen injector for infertility treatment. Expert Opin Drug Deliv. 2016;12:1–9.
   Web of Science ®Google Scholar
• Schertz J, Worton H. Patient evaluation of the redesigned follitropin alfa pen injector. Expert Opin Drug Deliv. 2017;2017(14):473–481.
   Google Scholar
• Medical devices – application of risk management to medical devices: International Organization for Standardization, Geneva, Switzerland. 2007. [cited 2017 Nov 28]. Available from: https://www.iso.org/standard/72704.html
   Google Scholar
• What to do if you can’t find a sharps disposal container: US Food and Drug Administration, Silver Spring. 2014. [cited 2017 Nov 28]. Available from: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/Sharps/ucm263259.htm
   Google Scholar
• Schertz JC, Saunders H, Hecker C, et al. The redesigned follitropin alfa pen injector: results of the patient and nurse human factors usability testing. Expert Opin Drug Deliv. 2011;8(9):1111–1120.
   PubMed Web of Science ®Google Scholar