Medical Devices: Evidence and Research (Sep 2015)
Acceptability of the reusable SurePal™ self-injection device for Omnitrope® among pediatric patients: results from a questionnaire-based, cross-sectional, multicenter observational study
Abstract
Carl-Joachim Partsch,1 Dirk Schnabel,2 Sarah Ehtisham,3 Helen C Johnstone,4 Markus Zabransky,5 Wieland Kiess61Endokrinologikum Hamburg, Hamburg, 2Division of Endocrinology and Diabetology, Otto-Heubner-Center for Pediatric and Adolescent Medicine, Charité University, Berlin, Germany; 3Central Manchester University Hospitals NHS Foundation Trust, Manchester, 4The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK; 5Sandoz International GmbH, Holzkirchen, 6Department of Women and Child Health, Hospital for Children and Adolescents, University Hospitals, University of Leipzig, Leipzig, GermanyBackground: SurePal™ is a reusable self-injection system that has been developed to support daily administration of Omnitrope® (Sandoz, Kundl, Austria). A questionnaire-based cross-sectional survey was conducted to evaluate acceptability of, and preference for, SurePal™ in pediatric patients who were prescribed treatment with Omnitrope® within routine clinical care.Methods: This multicenter, observational study was incorporated into the ongoing non-interventional PATRO (PAtients TReated with Omnitrope®) Children study. Patients (or caregivers) were provided with a questionnaire that included five main topics; attractiveness of the device, training received, using SurePal™, the low drug wastage system, and experience versus other devices used previously (where applicable). Questions were scored on a 5-point scale, with -2 being the worst possible outcome (eg, very hard/very poor) and 2 being the best possible outcome (eg, very easy/excellent).Results: A total of 186 patients were included in this study (Germany, n=154; UK, n=32). The attractiveness of SurePal™ was rated as excellent/good by 87.1% of patients. Overall, 86.5% of patients found that using their SurePal™ was very easy/easy. Almost all patients (96.2%) found that preparing their SurePal™ for injection was very easy/easy, and 89.2% found that injecting with SurePal™ was very easy/easy. 85.5% of patients recorded that the dose memory function was helpful, and 87.6% that taking their SurePal™ apart after an injection was very easy/easy. Of the 88 patients who recorded that they had used the low drug waste feature, 89.8% found the feature to be helpful. Among pre-treated patients (n=42), 81% recorded that SurePal™ was much better/better than their previously used device.Conclusion: This questionnaire-based cross-sectional survey in pediatric patients confirms the ease of use and patient preference for SurePal™, a reusable self-injection system that has been developed to support daily administration of Omnitrope®.Keywords: PATRO children, Omnitrope, SurePal, self-injection, growth hormone, intervention adherence