References
- National Institute for Health and Care Excellence. Human growth hormone (somatropin) for the treatment of growth failure in children: technology appraisal guidance [TA188]. London: NICE; 2010.
- National Institute for Health and Care Excellence. Human growth hormone (somatropin) in adults with growth hormone deficiency: technology appraisal guidance [TA64]. London: NICE; 2003.
- Kapoor RR, Burke SA, Sparrow SE, et al. Monitoring of concordance in growth hormone therapy. Arch Dis Child. 2008 Feb;93(2):147–148.
- Bagnasco F, Di Iorgi N, Roveda A, et al. Prevalence and correlates of adherence in children and adolescents treated with growth hormone: a multicenter Italian study [Multicenter study]. Endocr Pract. 2017 Aug;23(8):929–941.
- Cutfield WS, Derraik JG, Gunn AJ, et al. Non-compliance with growth hormone treatment in children is common and impairs linear growth [Research support, non-U.S. Gov’t]. PLoS One. 2011 Jan 31;6(1):e16223.
- Sabaté E. Adherence to long-term therapies: evidence for action. Geneva: World Health Organization; 2003.
- Fisher BG, Acerini CL. Understanding the growth hormone therapy adherence paradigm: a systematic review [Review]. Horm Res Paediatr. 2013;79(4):189–196.
- Rohrer TR, Horikawa R, Kappelgaard AM. Growth hormone delivery devices: current features and potential for enhanced treatment adherence [Review Research Support, Non-U.S. Gov’t]. Expert Opin Drug Deliv. 2017 Nov;14(11):1253–1264.
- Raimer-Hall D, Shea HC. Evolution of growth hormone devices: matching devices with patients [Comparative Study Research Support, Non-U.S. Gov’t Review]. Pediatr Nurs. 2015 Mar-Apr;41(2):72–77.
- Sauer M, Abbotts C. A new pen device for injection of recombinant human growth hormone: a convenience, functionality and usability evaluation study. Patient Prefer Adherence. 2018;12:27–34.
- International Organization for Standardization. IEC 62366-1:2015 medical devices - part 1: application of usability engineering to medical devices. Geneva: International Organization for Standardization; 2015.
- International Organization for Standardization. IEC 62366-2:2016 medical devices - part 2: guidance on the applicability of usability engineering to medical devices. Geneva: International Organization for Standardization; 2016.
- UK Medicines and Healthcare Products Regulatory Agency. Human factors and usablity engineering - guidance for medical devices including drug-device combination products. London: MHRA; 2017.
- Lange J, Richard P, Bradley N. Usability of devices for self-injection: results of a formative study on a new disposable pen injector. Med Devices (Auckl). 2014;7:195–203.
- European Medicines Agency. Good practice guide on risk minimisation and prevention of medication errors. Eur Med Agency. 2015. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/good-practice-guide-risk-minimisation-prevention-medication-errors_en.pdf
- European Pharmaceutical Market Research Association. EphMRA code of conduct. Bromley, Kent (UK): European Pharmaceutical Market Research Association; 2017.
- Mahony M, Dwyer A, Barkume R, et al. US 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 Jan;15(1):5–15.
- 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 Sep;13(9):1221–1229.
- Travanty MN, Calawa B, Shalaby WS, et al. Development and usability of a new subcutaneous auto-injector device to administer hydroxyprogesterone caproate to reduce the risk of recurrent preterm birth. Med Devices (Auckl). 2018;11:241–252.
- Fujioka K, Sparre T, Sun LY, et al. Usability of the novel liraglutide 3.0 mg pen injector among overweight or obese adult patients with or without prior injection experience. J Diabetes Sci Technol. 2015 July 16;10(1):164–174.
- US Food and Drug Administration. Guidance for industry and food and drug administration staff: applying human factors and usability engineering to medical devices. Rockville, MA, USA: FDA; 2016.
- Wilcox SB, Drucker D. Implications of the new food and drug administration draft guidance on human factors engineering for diabetes device manufacturers. J Diabetes Sci Technol. 2012 Mar 1;6(2):231–235.