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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

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          Abstract

          Close adherence to the recommended treatment regimen is important for the success of recombinant human growth hormone therapy, although nonadherence can be common. Ease of use and safety during use/storage are among several important factors in the design of a growth hormone injection device intended for long-term use. This study was performed to validate the usability and assess the ease of use of a new pen device (SurePal™) that has been developed to support daily administration of the recombinant human growth hormone product, Omnitrope® (somatropin). The primary objectives of the study were to assess if study participants, representing intended users of the pen in clinical practice, were able to perform an injection procedure into an injection pad effectively and safely and disassemble the pen without receiving a needlestick injury. A total of 106 participants (61 adults and 45 children/adolescents) were enrolled at two study centers (one in the US, one in Germany). Results for both primary usability tasks met the predefined acceptance criteria, with >85% of participants successfully performing each task. All of the other tasks/handling steps assessed were also successfully performed by most participants, with high success rates reflected in the high proportion of participants who classified each task as “very easy” or “easy”. After a second use of the device, 87%–97% of participants rated it as “very easy” or “easy” to use. In summary, the new pen device is safe and easy to use for both adults and children, and will help to support effective, long-term daily administration of the recombinant human growth hormone product, Omnitrope®.

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          Most cited references34

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          Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II: a statement of the GH Research Society in association with the European Society for Pediatric Endocrinology, Lawson Wilkins Society, European Society of Endocrinology, Japan Endocrine Society, and Endocrine Society of Australia.

          Ken Ho (2007)
          The GH Research Society held a Consensus Workshop in Sydney, Australia, 2007 to incorporate the important advances in the management of GH deficiency (GHD) in adults, which have taken place since the inaugural 1997 Consensus Workshop. Two commissioned review papers, previously published Consensus Statements of the Society and key questions were circulated before the Workshop, which comprised a rigorous structure of review with breakout discussion groups. A writing group transcribed the summary group reports for drafting in a plenary forum on the last day. All participants were sent a polished draft for additional comments and gave signed approval to the final revision. Testing for GHD should be extended from hypothalamic-pituitary disease and cranial irradiation to include traumatic brain injury. Testing may indicate isolated GHD; however, idiopathic isolated GHD occurring de novo in the adult is not a recognized entity. The insulin tolerance test, combined administration of GHRH with arginine or growth hormone-releasing peptide, and glucagon are validated GH stimulation tests in the adult. A low IGF-I is a reliable diagnostic indicator of GHD in the presence of hypopituitarism, but a normal IGF-I does not rule out GHD. GH status should be reevaluated in the transition age for continued treatment to complete somatic development. Interaction of GH with other axes may influence thyroid, glucocorticoid, and sex hormone requirements. Response should be assessed clinically by monitoring biochemistry, body composition, and quality of life. There is no evidence that GH replacement increases the risk of tumor recurrence or de novo malignancy.
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            Consensus guidelines for the diagnosis and treatment of growth hormone (GH) deficiency in childhood and adolescence: summary statement of the GH Research Society. GH Research Society.

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              Non-Compliance with Growth Hormone Treatment in Children Is Common and Impairs Linear Growth

              Background GH therapy requires daily injections over many years and compliance can be difficult to sustain. As growth hormone (GH) is expensive, non-compliance is likely to lead to suboptimal growth, at considerable cost. Thus, we aimed to assess the compliance rate of children and adolescents with GH treatment in New Zealand. Methods This was a national survey of GH compliance, in which all children receiving government-funded GH for a four-month interval were included. Compliance was defined as ≥85% adherence (no more than one missed dose a week on average) to prescribed treatment. Compliance was determined based on two parameters: either the number of GH vials requested (GHreq) by the family or the number of empty GH vials returned (GHret). Data are presented as mean ± SEM. Findings 177 patients were receiving GH in the study period, aged 12.1±0.6 years. The rate of returned vials, but not number of vials requested, was positively associated with HVSDS (p<0.05), such that patients with good compliance had significantly greater linear growth over the study period (p<0.05). GHret was therefore used for subsequent analyses. 66% of patients were non-compliant, and this outcome was not affected by sex, age or clinical diagnosis. However, Maori ethnicity was associated with a lower rate of compliance. Interpretation An objective assessment of compliance such as returned vials is much more reliable than compliance based on parental or patient based information. Non-compliance with GH treatment is common, and associated with reduced linear growth. Non-compliance should be considered in all patients with apparently suboptimal response to GH treatment.
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                Author and article information

                Journal
                Med Devices (Auckl)
                Med Devices (Auckl)
                Medical Devices: Evidence and Research
                Medical Devices (Auckland, N.Z.)
                Dove Medical Press
                1179-1470
                2013
                02 September 2013
                : 6
                : 141-146
                Affiliations
                [1 ]Division of Pediatric Endocrinology and Diabetes, Mount Sinai School of Medicine, Mineola, NY, USA
                [2 ]Winthrop University Hospital, Mineola, NY, USA
                [3 ]University Children’s Hospital, Division of Endocrinology and Diabetology, Munich, Germany
                [4 ]Department of Endocrinology and Metabolism, Tokyo Metropolitan Children’s Medical Center, Tokyo, Japan
                [5 ]25 rue Boudet, Bordeaux, France
                [6 ]Servizio di Endocrinologia Pediatrica, Ospedale Microcitemico ASL Cagliari, Cagliari, Italy
                [7 ]Clinica de Endocrinologia Pediátrica, Londrina, Brazil
                [8 ]Division of Pediatric Endocrinology, Technical University München, Munich, Germany
                [9 ]Sandoz International GmbH, Holzkirchen, Germany
                [10 ]Pediatric Sunshine Academics, Inc, Santa Barbara, CA, USA
                Author notes
                Correspondence: Markus Zabransky, Sandoz International GmbH, Industriestr 25, D-83607 Holzkirchen, Germany, Tel +49 80 24476 2255, Email markus.zabransky@ 123456sandoz.com
                Article
                mder-6-141
                10.2147/MDER.S50088
                3770891
                24039458
                5eebad9d-5ac3-479c-92c4-aa8f99512a83
                © 2013 Rapaport et al. This work is published by Dove Medical Press Ltd, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Ltd, provided the work is properly attributed.

                History
                Categories
                Original Research

                Biotechnology
                ease of use,growth hormone,omnitrope®,surepal™,pen device
                Biotechnology
                ease of use, growth hormone, omnitrope®, surepal™, pen device

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