title: The redesigned follitropin alfa pen injector: results of the patient and nurse human factors usability testing.
abstract: OBJECTIVE
  A redesigned pen injector for administration of follitropin alfa (follitropin α) has been developed for use in fertility treatment cycles. Pre-summative and summative usability testing was undertaken to assess the risk of dosing errors compared with the existing follitropin α pen. The study also assessed proper use of and dose selection with the redesigned pen.
  
  
  METHODS
  Infertile women who were trying to conceive and specialist nurses were recruited from four cities in Germany. Usability goals relating to proper use of the pen device were defined from a risk assessment and further categorized as critical and functional operational goals. Individual, non-interventional, standardized, usability tests were performed with patients and nurses by four experienced research professionals using questionnaires that also included ease-of-use ratings. A non-standardized qualitative analysis of nurse-patient training sessions was performed in the presence of a research professional; reasons for confidence, safety, possible misunderstandings and risks when handling the pen were noted.
  
  
  RESULTS
  The overall risk of dosing errors with the redesigned pen was not higher than with the existing pen. No unexpected operational risks and no major concerns regarding the risk of misuse or dosing errors were identified.
  
  
  CONCLUSIONS
  The study provides useful practical information on the redesigned pen from both patient and nurse perspectives.
authors.affiliation: Fertility Global Clinical Development Unit, EMD Serono, Inc., Rockland, MA 02370, USA. joan.schertz@emdserono.com
authors.forename: Joan C
authors.initials: JC
authors.lastname: Schertz
authors.forename: Helen
authors.initials: H
authors.lastname: Saunders
authors.forename: Clara
authors.initials: C
authors.lastname: Hecker
authors.forename: Barbara
authors.initials: B
authors.lastname: Lang
authors.forename: Pablo
authors.initials: P
authors.lastname: Arriagada
mesh_terms: D000328:Adult; D001291:Attitude of Health Personnel; D004867:Equipment Design; D005260:Female; D005307:Fertilization in Vitro; D043373:Follicle Stimulating Hormone, Human / Q000008:administration & dosage* / Q000627:therapeutic use; D005858:Germany; D015292:Glycoprotein Hormones, alpha Subunit / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D007247:Infertility, Female / Q000188:drug therapy* / Q000523:psychology; D007279:Injections, Subcutaneous / Q000009:adverse effects / Q000295:instrumentation*; D008422:Materials Testing; D008508:Medication Errors / Q000517:prevention & control; D008875:Middle Aged; D009726:Nurses / Q000523:psychology; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D010865:Pilot Projects; D011994:Recombinant Proteins / Q000008:administration & dosage; D018570:Risk Assessment; D012646:Self Administration / Q000009:adverse effects / Q000295:instrumentation; D011795:Surveys and Questionnaires
chemical_list: D043373:Follicle Stimulating Hormone, Human; D015292:Glycoprotein Hormones, alpha Subunit; D011994:Recombinant Proteins