User trial of Easypod™, an electronic autoinjector for growth hormone

Tauber, Maïthé; Payen, Catherine; Cartault, Audrey; Jouret, Béatrice; Edouard, Thomas; D, Roger

doi:10.1016/j.ando.2008.04.003

Cited by 18 publications

(16 citation statements)

References 13 publications

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“…These results support the findings of previous, smaller (up to 61 patients), shorter-term (up to 60 days) studies, which together indicate a high level of patient acceptance of the electronic auto-injector for daily administration of r-hGH [14,15]. Results from an open-label multicentre survey that included 61 patients showed that the majority of patients had a good overall impression of the device after 60 days of use [14].…”

Section: Discussionsupporting

confidence: 89%

“…In addition, the nurses/physicians who trained them how to use the device also rated the device favourably with respect to participants' ease in learning to use the device [14]. Unlike previous user trials of the electronic auto-injector [14,15], the current study is the first to include data on adherence as captured using the device.…”

Section: Discussionmentioning

confidence: 99%

“…This information can be accessed by patients or downloaded at their clinic to show which injections, if any, have been missed. Although patient opinion of the electronic auto-injector has been previously studied, albeit in a limited number of patients (n = 61) [14,15], adherence to treatment whilst using this device has not been explored at all.…”

Section: Introductionmentioning

confidence: 99%

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Treatment adherence with the easypod™ growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents

Bozzola

Colle²,

Halldin-Stenlid

et al. 2011

BMC Endocr Disord

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BackgroundAccurately monitoring adherence to treatment with recombinant human growth hormone (r-hGH) enables appropriate intervention in cases of poor adherence. The electronic r-hGH auto-injector, easypod™, automatically records the patient's adherence to treatment. This study evaluated adherence to treatment of children who started using the auto-injector and assessed opinions about the device.MethodsA multicentre, multinational, observational 3-month survey in which children received r-hGH as part of their normal care. Physicians reviewed the recorded dose history and children (with or without parental assistance) completed a questionnaire-based survey. Children missing ≤2 injections per month (92% of injections given) were considered adherent to treatment. Adherence was compared between GH treatment-naïve and treatment-experienced children.ResultsOf 834 recruited participants, 824 were evaluated. The median (range) age was 11 (1-18) years. From the recorded dose history, 87.5% of children were adherent to treatment over the 3-month period. Recorded adherence was higher in treatment-naïve (89.7%, n = 445/496) than in treatment-experienced children (81.7%, n = 152/186) [Fisher's exact test FI(X) = 7.577; p = 0.0062]. According to self-reported data, 90.2% (607/673) of children were adherent over 3 months; 51.5% (421/817) missed ≥1 injection over this period (mainly due to forgetfulness). Concordance between reported and recorded adherence was 84.3%, with a trend towards self-reported adherence being higher than recorded adherence. Most children liked the auto-injector: over 80% gave the top two responses from five options for ease of use (720/779), speed (684/805) and comfort (716/804). Although 38.5% (300/780) of children reported pain on injection, over half of children (210/363) considered the pain to be less or much less than expected. Given the choice, 91.8% (732/797) of children/parents would continue using the device.Conclusionseasypod™ provides an accurate method of monitoring adherence to treatment with r-hGH. In children who received treatment with r-hGH using easypod™, short-term adherence is good, and significantly higher in treatment-naïve children compared with experienced children. Children/parents rate the device highly. The high level of acceptability of the device is reflected by a desire to continue using it by over 90% of the children in the survey.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Treatment adherence with the easypod™ growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents

Bozzola

Colle²,

Halldin-Stenlid

et al. 2011

BMC Endocr Disord

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“…Overall, delivery systems with needle-free designs were preferred by patients. At least five studies reported a degree of automation in the device as one of the key factors affecting choice of delivery systems (Ahmed et al, 2008;Dahlgren et al, 2007;Fuchs et al, 2009;Shine et al, 2003;Tauber et al, 2008), and only one study (Wickramasuriya et al, 2006) did not find that automation influenced patient preference. Wickramasuriya et al (2006)…”

Section: Resultsmentioning

confidence: 99%

“…The reasons for this higher preference were ease of use, less time‐consuming procedures by avoiding any reconstitution, less painful injection, and acceptable drug tolerability. Additionally, one open‐label, multicenter study that evaluated patients' acceptability of Easypod ® (EMD Serono, Rockland, MA, USA) among patients diagnosed with GHD, Turner syndrome, CRI, or SGA (Dahlgren et al., 2007; Tauber et al., 2008), showed that factors such as display of the remaining drug in the cartridge, preprogrammed dosing, on‐screen instructions, and automatic needle attachment were viewed “very useful” by all patients studied (Dahlgren et al., 2007; Tauber et al., 2008).…”

mentioning

confidence: 99%

Human growth hormone treatment: Synthesis of literature on product delivery systems and administration practices

Bhosle

Klingman

Aagren

et al. 2011

Journal for Specialists in Pediatric Nursing

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Adherence in children with growth hormone deficiency treated with r-hGH and the easypod™ device

Loche

Salerno

Garofalo

et al. 2016

J Endocrinol Invest

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PurposePoor adherence to recombinant human growth hormone (r-hGH) therapy is associated with reduced growth velocity in children with growth hormone deficiency (GHD). This twelve-month observational study was to assess adherence in r-hGH patients treated with the easypod™, an electronic, fully automated injection device designed to track the time, date and dose administered.MethodsNinety-seven prepubertal patients receiving r-hGH therapy were included in the study from ten Italian clinical sites and 88 completed the study. To avoid possible confounding effects, only GHD patients (79/88; 89.7 % of the overall study population) were considered in the final analysis. The primary endpoint—adherence to treatment—was calculated as the proportion of injections correctly administered during the observational period out of the expected total number of injections. The relevant information, tracked by the easypod™, was collected at months 6 (V1) and 12 (V2) after baseline (V0). At study termination, adherence data were partially available from 16 patients and fully available from 53 patients. As secondary endpoints, serum IGF-1 levels, fasting serum glucose and insulin levels and key anthropometric characteristics (height, waist circumference and BMI) were also determined. ResultsThe easypod™ data showed that 56.7 % of the patients were considered to be fully (≥92 %) adherent to their treatment throughout the period V0–V2. Treatment improved stature, significantly increased IGF-1 and produced a non-significant increase in blood glucose and insulin levels.ConclusionsThe injection-recording system and other characteristics of easypod™ could enhance the ability of physicians to monitor adherence to r-hGH treatment.

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User trial of Easypod™, an electronic autoinjector for growth hormone

Cited by 18 publications

References 13 publications

Treatment adherence with the easypod™ growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents

Treatment adherence with the easypod™ growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents

Human growth hormone treatment: Synthesis of literature on product delivery systems and administration practices

Adherence in children with growth hormone deficiency treated with r-hGH and the easypod™ device

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