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Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays
Published on: January 7, 2016
Acceptance of a reusable self-injection device for recombinant human growth hormone: final data from a
Dirk Schnabel1, Carl-Joachim Partsch2, Muriel Houang3
1Pediatric Endocrinology, Center for Chronic Sick Children, Otto-Heubner-Centrum für Kinder- und Jugendmedizin, Charite, University Medicine, Berlin, Germany.
Insights
Pediatric patients with growth disturbances prefer the SurePal™ self-injection system for Omnitrope® treatment. The reusable device demonstrated ease of use, high patient satisfaction, and better performance compared to previous systems.
Area of Science:
- Pediatric Endocrinology
- Drug Delivery Systems
- Patient Reported Outcomes
Background:
- Growth disturbances in children often require long-term injectable therapies like Omnitrope®.
- Self-injection systems aim to improve treatment adherence and patient experience.
Purpose of the Study:
- To assess pediatric patient and caregiver attitudes towards the SurePal™ reusable self-injection system.
- To evaluate the usability and patient preference for SurePal™ in the context of Omnitrope® treatment for growth disturbances.
Main Methods:
- A multicenter, observational study involving 550 pediatric patients treated with Omnitrope®.
- Questionnaire-based survey assessing device attractiveness, training, usability, drug wastage, and comparison to prior devices.
- Responses collected on a 5-point Likert scale.
Main Results:
- High patient preference for SurePal™ (84.7% rated excellent/good attractiveness).
- Ease of preparation (88.8%) and use (83.3%) reported by most patients.
- Significant preference for self-administration increased with age, and 78.2% of previously treated patients found SurePal™ better than prior devices.
Conclusions:
- SurePal™ is a user-friendly and preferred self-injection system for pediatric growth hormone therapy.
- The system's design, including dose memory and low drug wastage, contributes to positive patient-reported outcomes.
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.
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