Validation and ease of use of a new pen device for self-administration of recombinant human growth hormone: results from a two-center usability study

Rapaport, Robert; Saenger, Paul; Schmidt, Heinrich Richard; Hasegawa, Yukihiro; Colle, M.; Loche, Sandro; Marcantonio, Sandra; Bonfig, Walter; Zabransky, Markus; Lifshitz, Fima

doi:10.2147/mder.s50088

Cited by 9 publications

(17 citation statements)

References 30 publications

(22 reference statements)

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“…Devices that are easier to use can improve a patient’s ability and willingness to comply with treatment. It has been reported that the choice of an adequate drug delivery device is associated with greater patient compliance and improved clinical outcomes 12,13…”

Section: Discussionmentioning

confidence: 99%

Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults

Pleil¹,

Darendelıler²,

Dörr³

et al. 2014

MDER

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Previous research has reported that ease of use of and preference for a delivery device are associated with greater patient compliance – an important factor in achieving optimal therapeutic results. The objective of this study was to assess the ease-of-use of a new disposable pen (GoQuick®, Pfizer, Inc.) versus the current reusable pen (GENOTROPIN Pen®, Pfizer, Inc.) to inject a daily dose of recombinant DNA origin human growth hormone, Genotropin® (somatropin) in standard practice. In this randomized, crossover, multicenter, multinational, open-label study, ease-of-use of and preference for the two pens were assessed in three treatment-naïve populations: 1) parents of very young children; 2) parent–child dyads; and 3) adults via use of a validated self-report Injection Pen Assessment Questionnaire (IPAQ) after 2 months of at-home-use experience. The primary endpoint was the proportion of participants who reported the new disposable pen to be no different from or easier to use than the current reusable pen. Safety was also assessed and reported according to local legal requirements. Of the 120 screened patients, 119 were included in the ease-of-use analysis and all were included in the safety analyses. In all, 67.2% found the new somatropin disposable pen to be no different from or easier to use than the reusable pen (95% confidence interval: 58.8–75.7). Most adverse events were mild or moderate. No deaths or device- or treatment-related serious adverse events were reported. These results suggest that improvements made to the reusable somatropin pen are tangible and recognizable to treatment-naïve patients and their caregivers, child–caregiver dyads, and adults, and may positively impact continued compliance with therapy.Registry informationClinicalTrials.gov identifier: NCT01112865.

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Section: Discussionmentioning

confidence: 99%

Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults

Pleil¹,

Darendelıler²,

Dörr³

et al. 2014

MDER

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“…The vast majority of participants overall found SurePal™ very easy or easy to use for injection, which is a factor associated with choice of device and successful adherence with treatment. 7 , 11 SurePal™ has various features that may have contributed to patients rating of the device as easy to use. These include an autopriming feature, cartridges that are preassembled and ready to use, a sliding injection button that requires minimum force to perform an injection, and a dose-memory function that enables the correct dose to be preset and locked into the device.…”

Section: Discussionmentioning

confidence: 99%

“… 3 Improving adherence to therapy may be challenging, given the need for long-term subcutaneous administration of rhGH. 7 Enhanced self-administration devices may play a role in improving adherence. 2 , 3 Device-related factors affecting adherence include the patient’s preference for the delivery device, its simplicity, convenience, and ease of use, together with the provision of appropriate education and training in the administration technique.…”

Section: Introductionmentioning

confidence: 99%

“…SurePal™ is specifically designed to be easy and convenient to use and to minimize drug wastage. 7 In a study conducted to validate usability and assess ease of use of SurePal™ in adults and children/adolescents (n=106) in Germany and the US, 92% of participants rated the injection procedure (into an injection pad) as very easy or easy. 7 In addition, 99% were able to disassemble the pen device successfully.…”

Section: Introductionmentioning

confidence: 99%

“… 7 In a study conducted to validate usability and assess ease of use of SurePal™ in adults and children/adolescents (n=106) in Germany and the US, 92% of participants rated the injection procedure (into an injection pad) as very easy or easy. 7 In addition, 99% were able to disassemble the pen device successfully. Both naïve and experienced participants found the pen easy to use, which is a factor associated with successful adherence to treatment.…”

Section: Introductionmentioning

confidence: 99%

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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

Schnabel

Partsch

Houang

et al. 2016

MDER

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BackgroundA 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.MethodsThis 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.ResultsIn 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.ConclusionThese data confirm the ease of use and patient preference for SurePal™ among pediatric patients with growth disturbances.

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Patients’ perceptions on the usability of the SurePal™ self-injection device for Omnitrope^®: a questionnaire-based observational study conducted in paediatric patients in France

Coutant

Dupuis

Pigeon

et al. 2017

Therapeutic Advances in Endocrinology

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Background: A questionnaire-based survey was conducted to evaluate attitudes towards a reusable self-injection system, SurePal™, among paediatric patients with growth disturbances who were prescribed treatment with somatropin (Omnitrope ® ) as part of routine clinical practice. Methods: This cross-sectional survey was incorporated into the multinational, multi-centre, noninterventional PAtients TReated with Omnitrope ® (PATRO) Children study. Questions were mainly focused on five areas: the attractiveness of SurePal™; training received; use of the device; opinion of the low-drug wastage system; experience compared with previous devices used (among pretreated patients). Results:Final results from participants in France are reported. Completed questionnaires were returned by 409 participants. Most patients (55%) were male and 89% were recombinant human growth hormone (rhGH)-treatment naïve. Around 57% of children completed the questionnaire by themselves, while 43% had help from a family member/other person. The mean (standard deviation) age of all participants was 11.3 (3.6) years, and most patients were aged 10-12 years (n = 126) or 13-15 years (n = 117). Overall, 86% of patients reported that preparing SurePal™ for injection was easy/very easy. Similarly, 83% reported that performing injections with SurePal™ was easy/very easy. The attractiveness of SurePal™ was rated as good/excellent by the majority (85%) of patients; this proportion was similarly high (> 80%) across all age groups. The dose-memory function was rated as helpful/very helpful by 54% of patients. Of the 174 patients who reported using the low drug-waste feature, 90% found it to be helpful/very helpful. Among the 24 pretreated patients, 17 reported that SurePal™ was better/much better than their previous device. Conclusions: This questionnaire-based survey conducted in a large cohort of paediatric patients with growth disturbances from France confirms the ease of use of SurePal™ to support daily administration of Omnitrope ® across all age groups. The demonstrated acceptability of the device may help to improve patient adherence to long-term daily treatment with rhGH.

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Validation and ease of use of a new pen device for self-administration of recombinant human growth hormone: results from a two-center usability study

Cited by 9 publications

References 30 publications

Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults

Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults

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

Patients’ perceptions on the usability of the SurePal™ self-injection device for Omnitrope^®: a questionnaire-based observational study conducted in paediatric patients in France

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Validation and ease of use of a new pen device for self-administration of recombinant human growth hormone: results from a two-center usability study

Cited by 9 publications

References 30 publications

Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-na&iuml;ve children and adults

Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-na&iuml;ve children and adults

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

Patients’ perceptions on the usability of the SurePal™ self-injection device for Omnitrope®: a questionnaire-based observational study conducted in paediatric patients in France

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Product

Resources

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Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults

Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naïve children and adults

Patients’ perceptions on the usability of the SurePal™ self-injection device for Omnitrope^®: a questionnaire-based observational study conducted in paediatric patients in France