title: Psychometric assessment of the Injection Pen Assessment Questionnaire (IPAQ): measuring ease of use and preference with injection pens for human growth hormone.
abstract: OBJECTIVE
  To examine the psychometric properties of the Injection Pen Assessment Questionnaire (IPAQ) including the following: 1) item and scale characteristics (e.g., frequencies, item distributions, and factor structure), 2) reliability, and 3) validity.
  
  
  METHODS
  Focus groups and one-on-one dyad interviews guided the development of the IPAQ. The IPAQ was subsequently tested in 136 parent-child dyads in a Phase 3, 2-month, open-label, multicenter trial for a new Genotropin(®) disposable pen. Factor analysis was performed to inform the development of a scoring algorithm, and reliability and validity of the IPAQ were evaluated using the data from this two months study. Psychometric analyses were conducted separately for each injection pen.
  
  
  RESULTS
  Confirmatory factor analysis provides evidence supporting a second order factor solution for four subscales and a total IPAQ score. These factor analysis results support the conceptual framework developed from previous qualitative research in patient dyads using the reusable pen. However, the IPAQ subscales did not consistently meet acceptable internal consistency reliability for some group level comparisons. Cronbach's alphas for the total IPAQ score for both pens were 0.85, exceeding acceptable levels of reliability for group comparisons.
  
  
  CONCLUSIONS
  The total IPAQ score is a useful measure for evaluating ease of use and preference for injection pens in clinical trials among patient dyads receiving hGH. The psychometric properties of the individual subscales, mainly the lower internal consistency reliability of some of the subscales and the predictive validity findings, do not support the use of subscale scores alone as a primary endpoint.
authors.affiliation: Pfizer, Inc, 10555 Science Center Dr, San Diego, CA 92121, USA. andreas.m.pleil@pfizer.com
authors.forename: Andreas M
authors.initials: AM
authors.lastname: Pleil
authors.forename: Miriam
authors.initials: M
authors.lastname: Kimel
authors.forename: Julie
authors.initials: J
authors.lastname: McCormack
authors.forename: Natasa
authors.initials: N
authors.lastname: Rajicic
authors.forename: Judith
authors.initials: J
authors.lastname: Hey-Hadavi
mesh_terms: D005163:Factor Analysis, Statistical; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy*; D019382:Human Growth Hormone / Q000008:administration & dosage* / Q000172:deficiency; D006801:Humans; D007277:Injections, Jet; D007279:Injections, Subcutaneous / Q000295:instrumentation*; D008297:Male; D009339:Needles; D057240:Patient Preference / Q000523:psychology* / Q000706:statistics & numerical data; D011594:Psychometrics; D011795:Surveys and Questionnaires; D013594:Syringes
chemical_list: D019382:Human Growth Hormone