Medical Devices: Evidence and Research (Sep 2016)
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
Dirk Schnabel,1 Carl-Joachim Partsch,2 Muriel Houang,3 Sarah Ehtisham,4 Helen Johnstone,5 Markus Zabransky,6 Wieland Kiess7 1Pediatric Endocrinology, Center for Chronic Sick Children, Otto-Heubner-Centrum für Kinder- und Jugendmedizin, Charite, University Medicine, Berlin, Germany; 2Endokrinologikum Hamburg, Hamburg, Germany; 3Explorations Fonctionnelles Endocriniennes, Hôpital Armand Trousseau, Paris, France; 4Mediclinic City Hospital, Dubai Healthcare City, Dubai, United Arab Emirates; 5The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK; 6Sandoz International GmbH, Holzkirchen, 7Department of Women and Child Health, Hospital for Children and Adolescents, University Hospitals, University of Leipzig, Leipzig, Germany 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.Conclusion: These data confirm the ease of use and patient preference for SurePal™ among pediatric patients with growth disturbances. Keywords: PATRO children, Omnitrope®, SurePal™, self-injection, growth hormone, intervention adherence
