title: Acceptance of a reusable self-injection device for recombinant human growth hormone: final data from a questionnaire-based, cross-sectional, international, multicenter, observational study in pediatric patients.
abstract: BACKGROUND
  A questionnaire-based survey was conducted to assess attitudes toward a reusable self-injection system (SurePal™) among pediatric patients with growth disturbances who were prescribed treatment with Omnitrope(®) within routine clinical practice.
  
  
  METHODS
  This was a multicenter, observational study, incorporated into the noninterventional PAtients TReated with Omnitrope(®) (PATRO) Children study. Included subjects, or their caregivers, completed a questionnaire on the following five main areas: attractiveness of SurePal™, training received, using the device, the low drug wastage system, and experience versus other devices used previously (pretreated patients). Responses were based on a 5-point scale, with 2 being the best possible outcome and -2 the worst possible outcome.
  
  
  RESULTS
  In total, 550 patients were included in this study (338 from France, 169 from Germany, and 43 from the UK). The mean age ± standard deviation of participants was 10.8±3.5 years; the majority (57%) were male and growth hormone treatment naïve (88%). Almost half (49.8%) of children prepared their SurePal™ for injection themselves and 45.5% performed injections themselves. As patients progressed into their teens, the majority (≥75%) favored preparing SurePal™ and performing injections themselves, rather than seeking assistance. The attractiveness of SurePal™ was rated as excellent/good by 84.7% of patients overall; this rating was similarly high (≥79%) across countries and age-groups. Preparing (88.8%) and using (83.3%) SurePal™ were rated as very easy/easy by most patients; these ratings were similarly high, irrespective of country or age-group. The dose-memory function was rated as very helpful/helpful by 66.2% of patients. Among 246 patients who reported using the low drug-waste feature, 87.4% found it helpful. Among pretreated patients (n=64), 78.2% reported that SurePal™ was much better/better than their previous device.
  
  
  CONCLUSIONS
  These data confirm the ease of use and patient preference for SurePal™ among pediatric patients with growth disturbances.
authors.affiliation: Pediatric Endocrinology, Center for Chronic Sick Children, Otto-Heubner-Centrum für Kinder- und Jugendmedizin, Charite, University Medicine, Berlin, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Schnabel
authors.affiliation: Endokrinologikum Hamburg, Hamburg, Germany.
authors.forename: Carl-Joachim
authors.initials: CJ
authors.lastname: Partsch
authors.affiliation: Explorations Fonctionnelles Endocriniennes, Hôpital Armand Trousseau, Paris, France.
authors.forename: Muriel
authors.initials: M
authors.lastname: Houang
authors.affiliation: Mediclinic City Hospital, Dubai Healthcare City, Dubai, United Arab Emirates.
authors.forename: Sarah
authors.initials: S
authors.lastname: Ehtisham
authors.affiliation: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Johnstone
authors.affiliation: Sandoz International GmbH, Holzkirchen.
authors.forename: Markus
authors.initials: M
authors.lastname: Zabransky
authors.affiliation: Department of Women and Child Health, Hospital for Children and Adolescents, University Hospitals, University of Leipzig, Leipzig, Germany.
authors.forename: Wieland
authors.initials: W
authors.lastname: Kiess
keywords: Omnitrope®; PATRO children; SurePal™; growth hormone; intervention adherence; self-injection