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  • 1
    Online Resource
    Online Resource
    Frontiers Media SA ; 2018
    In:  Frontiers in Endocrinology Vol. 8 ( 2018-1-11)
    In: Frontiers in Endocrinology, Frontiers Media SA, Vol. 8 ( 2018-1-11)
    Type of Medium: Online Resource
    ISSN: 1664-2392
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2018
    detail.hit.zdb_id: 2592084-4
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  • 2
    Online Resource
    Online Resource
    Frontiers Media SA ; 2023
    In:  Frontiers in Endocrinology Vol. 14 ( 2023-4-6)
    In: Frontiers in Endocrinology, Frontiers Media SA, Vol. 14 ( 2023-4-6)
    Abstract: The appropriate use of recombinant human growth hormone (r-hGH) treatment provides an opportunity to improve growth outcomes among pediatric patients with growth hormone deficiency (GHD). However, a major challenge in clinical practice is to adequately recognize and address factors that negatively affect treatment adherence. TUITEK ® patient support program (PSP) was designed to help caregivers of children diagnosed with GHD to personalize the care pathway, improve adherence, and achieve better outcomes. Effectiveness of TUITEK ® PSP has been demonstrated previously in a smaller sample (n = 31) in Taiwanese population. Here, we present the results from Argentina. Methods TUITEK ® PSP was piloted among 76 caregivers of children with GHD administering r-hGH using easypod™ (Merck KGaA, Darmstadt, Germany) auto-injector device in Argentina. Based on TUITEK ® personalization questionnaire, caregivers were assigned to high- and low-risk groups across four categories that may influence adherence, including disease and treatment coherence (DTC), self-administration (SA), treatment-related anxiety (TRA), and emotional burden (EB). The caregivers who were included in atleast one high-risk group had the provision of telephone calls with a nurse practitioner every 2 weeks for 3 months. The Wilcoxon signed-rank test was employed to assess changes in questionnaire-based scoring patterns between baseline and follow-up evaluations. Results Statistically significant changes ( p & lt; 0.05) in questionnaire scores between baseline and follow-up evaluations were observed across the four categories. The mean/median DTC (n = 11) and SA (n = 23) scores changed from 2.45/3 and 2.17/2, respectively, to 4/4, with all the caregivers moving to low-risk group following program completion (100%) for both categories. The mean/median TRA score (n = 40) changed from 3.58/3 to 2.5/2 and 67.5% of patients (27/40) moved to low-risk group. The mean/median EB score (n = 32) changed from 3.69/3 to 3.13/3 however, none of the caregivers moved to low-risk group (0%). Conclusion TUITEK ® PSP is a simple, practical, and time-efficient interventional tool that can be used to address key adherence-related issues among caregivers of children with GHD and provide personalized adherence support. Our findings demonstrate that TUITEK ® PSP has the potential to improve treatment adherence and self-management, thereby improving growth outcomes in Argentina.
    Type of Medium: Online Resource
    ISSN: 1664-2392
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2023
    detail.hit.zdb_id: 2592084-4
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  • 3
    In: Endocrine Connections, Bioscientifica, Vol. 7, No. 8 ( 2018-08), p. 914-923
    Abstract: The easypod connect observational study (ECOS) assessed treatment adherence among paediatric patients receiving growth hormone (GH) via the easypod electronic injection device. Design ECOS was an open-label, observational, longitudinal study conducted in 24 countries between 2010 and 2016, enrolling children treated with GH. Methods The primary endpoint was the rate of treatment adherence during 5 years of follow-up. Impact of adherence on growth outcomes was assessed using Spearman’s product–moment correlations. Results and conclusions Overall, 1190 patients had easypod data available for ≥3 months; most patients had GH deficiency (75%); 606 of these patients were GH naïve at baseline. Over the first year of monitoring, the median rate of adherence was 93.7% among patients overall and 〉 93.0% in GH-naïve patients, irrespective of the treatment indication. Clinically meaningful improvements in growth rates were observed after 1 year of treatment across all GH indications. Adherence decreased with increasing treatment duration, but the overall median adherence rate remained high after 3 years of follow-up: 87.2% ( n  = 409), 75.5% after 4 years ( n  = 143) and 70.2% after 5 years ( n  = 43). Statistically significant correlations between adherence and 1-year change in height standard deviation score ( P   〈  0.001 for patients overall) and height velocity ( P   〈  0.001) were observed. Conclusions ECOS produced accurate, real-time adherence data in a large population of GH-treated children over 5 years of follow-up. Using the easypod connect system, physicians can potentially identify patients with inadequate adherence and poor response to treatment, enabling them to take appropriate action to help them maximise the benefits of GH treatment.
    Type of Medium: Online Resource
    ISSN: 2049-3614
    Language: Unknown
    Publisher: Bioscientifica
    Publication Date: 2018
    detail.hit.zdb_id: 2668428-7
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  • 4
    Online Resource
    Online Resource
    The Endocrine Society ; 2023
    In:  Journal of the Endocrine Society Vol. 7, No. Supplement_1 ( 2023-10-05)
    In: Journal of the Endocrine Society, The Endocrine Society, Vol. 7, No. Supplement_1 ( 2023-10-05)
    Abstract: Disclosure: S. Loche: Advisory Board Member; Self; SL has received advisory board fees from the healthcare business of Merck KGaA, Darmstadt, Germany. Consulting Fee; Self; SL has received consultancy fees from the healthcare business of Merck KGaA, Darmstadt, Germany. Speaker; Self; SL has received lecture fees from the healthcare business of Merck KGaA, Darmstadt, Germany. P. van Dommelen: Consulting Fee; Self; PvD has a consultancy agreement with the healthcare business of Merck KGaA, Darmstadt, Germany. E. Koledova: Employee; Self; EK is an employee of the healthcare business of Merck KGaA, Darmstadt, Germany. Stock Owner; Self; EK holds shares in the healthcare business of Merck KGaA, Darmstadt, Germany. Background: In our previous study, a data-driven clinical decision support system based on “traffic light” visualizations for adherence risk management in patients receiving recombinant human growth hormone (r-hGH) treatment was developed.1 Two “traffic lights” were most promising: mean adherence and standard deviation (SD) of hours to next injection (administering injections at around the same time each day). We aimed to study the effect of these two adherence-based traffic lights on catch-up growth in the first year of treatment in patients with growth hormone deficiency (GHD) and those born small for gestational age (SGA). Data and Methods: Height and adherence data were extracted from the easypod™ connect ecosystem and taken from the easypod™ connect observational study.2 Patients with: height standard deviation scores (HSDS) of ≤-2 at treatment start; age 2-15 years at treatment start; and ≥1 measurement and adherence data available in the first year of treatment, were selected. Mean adherence was classified as high (≥85%), intermediate ( & gt;56%- & lt;85%), or low (≤56%); high (≥15.9 [P95]), intermediate (≥10.1 [P85] ), or low ( & lt;10.1) were used for SD of hours to next injection. Linear regression analysis was performed with ΔHSDS between treatment start and first year of treatment as dependent variables and the adherence-based values as independent variables, all adjusted for age and HSDS at treatment start. Results: In total, data for 1,045 patients (776 and 269 with GHD and those born SGA, respectively) were available. Only some of the adherence-based categories had a significant and independent effect on ΔHSDS (P=0.004). Adjusted for age and HSDS at treatment start, patients with high/intermediate mean adherence had, on average, a +0.15 SD higher ΔHSDS (P=0.004), while this was +0.09 SD for patients with a low SD of hours to the next injection (P=0.003). Therefore, patients with both high/intermediate mean adherence and a low SD of hours to the next injection had, on average, a +0.24 SD higher ΔHSDS compared with patients with both low mean adherence and a high SD of hours to the next injection. Conclusions: Our research shows that good adherence and administering injections around the same time each day play an essential role in optimizing catch-up growth. Adherence-based traffic lights can alert clinicians to have discussions with patients/caregivers to mitigate the risk of sub-optimal adherence and, consequently, improve catch-up growth. References: 1. Araújo M, et al. Stud Health Technol Inform 2021;287:23-7; 2. Koledova E, et al. Endocr Connect 2018;7:914-23. Presentation: Thursday, June 15, 2023
    Type of Medium: Online Resource
    ISSN: 2472-1972
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2023
    detail.hit.zdb_id: 2881023-5
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  • 5
    In: Journal of the Endocrine Society, The Endocrine Society, Vol. 3, No. Supplement_1 ( 2019-04-15)
    Type of Medium: Online Resource
    ISSN: 2472-1972
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2019
    detail.hit.zdb_id: 2881023-5
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  • 6
    In: European Journal of Endocrinology, Oxford University Press (OUP), Vol. 153, No. 1 ( 2005-07), p. 57-65
    Abstract: Objectives : To investigate the effects of growth hormone (GH) treatment, using a dose-adjustment regimen based on serum insulin-like growth factor (IGF)-I concentrations, in adult Japanese hypopituitary patients with GH deficiency. Study design : Japanese patients who had initially been administered GH ( n = 31) or placebo ( n = 28) in a 24-week double-blind study received individualized GH treatment in an open-label study for 48 weeks. Body composition from dual-energy X-ray absorptiometry (DXA) and serum IGF-I, IGF-binding protein 3 (IGFBP-3) and lipid levels were determined centrally. Results : Significant increases in lean body mass (4.5%) and decreases in fat mass (−10.5%) were observed in the group that received individualized GH doses in the present open-label study following placebo in the double-blind study. This was comparable with the changes observed in these parameters (4.7 and −9.2%, respectively) with fixed-dose GH treatment in the double-blind study; this latter group maintained these improvements throughout the open-label study. Individualized dose adjustment allowed for more moderate dose increases than the fixed-dose titration method. Individualized dosing also resulted in a lower mean dose for adult-onset compared with childhood-onset GH-deficient patients (0.032±0.019 versus 0.061±0.023 mg/kg per week for patients treated with GH for 48 weeks in the open-label study following placebo in the double-blind study). Dosing patterns in the two groups were paralleled by the changes in IGF-I and IGFBP-3. The incidence of oedema and cases with high IGF-I level were less frequent under the IGF-I controlled regimen compared with those during the fixed-dose titration method. Conclusion : Individualized GH administration based on IGF-I levels was safe and effective. This regimen demonstrated differences in dose requirements between adult- and childhood-onset patients. An individualized dose regimen is recommended in adult Japanese GH-deficient patients.
    Type of Medium: Online Resource
    ISSN: 0804-4643 , 1479-683X
    RVK:
    Language: Unknown
    Publisher: Oxford University Press (OUP)
    Publication Date: 2005
    detail.hit.zdb_id: 1485160-X
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  • 7
    Online Resource
    Online Resource
    JMIR Publications Inc. ; 2020
    In:  Journal of Medical Internet Research Vol. 22, No. 7 ( 2020-7-29), p. e18157-
    In: Journal of Medical Internet Research, JMIR Publications Inc., Vol. 22, No. 7 ( 2020-7-29), p. e18157-
    Abstract: Recombinant human growth hormone treatment can optimize growth potential; however, optimal outcomes are not always achieved for several reasons, including poor adherence. The overall objective of this project was to design a patient support program to maximize the chances of treatment success for people being treated with somatropin injection. An approach known as the behavior change wheel was used to enhance the development of the patient support program. The behavior change wheel provided a comprehensive framework to support the design of interventions. Objective The aim of this paper was to describe how the steps of the behavior change wheel were applied to the development of a patient support program for individuals with growth hormone deficiency undergoing treatment with somatropin. Methods We followed a series of steps that align to tenets of the behavior change wheel, namely, a narrative literature review to identify which behaviors needed to change and the potential drivers of and barriers to the behaviors, the selection of an intervention strategy and discrete behavior change techniques, and, finally, intervention specification. Results A recent systematic review identified a range of potentially modifiable factors found to have an influence on patient adherence to growth hormone treatment. Insights from the systematic review were used to guide the development of a patient support program. The final design of the patient support program consisted of four elements: (1) a personalization questionnaire to tailor support for each individual, (2) tailored reminder and support SMS text messages, (3) nurse-led phone calls, and (4) Easypod connect, an automated electronic autoinjector drug-delivery device with a transmitter and connection platform for Saizen (somatropin) that allows automatic recording, storage, and transmission of drug-usage data, thus providing insight into suboptimal adherence. Conclusions The patient support program that was designed is currently being piloted with patients to assess engagement with the program and determine its impact on patient outcomes. Results from the pilot will be used to further refine the program to ensure it meets user needs.
    Type of Medium: Online Resource
    ISSN: 1438-8871
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2020
    detail.hit.zdb_id: 2028830-X
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  • 8
    Online Resource
    Online Resource
    Frontiers Media SA ; 2023
    In:  Frontiers in Public Health Vol. 11 ( 2023-4-18)
    In: Frontiers in Public Health, Frontiers Media SA, Vol. 11 ( 2023-4-18)
    Abstract: Growth hormone deficiency (GHD) is a rare disorder characterized by inadequate secretion of growth hormone (GH) from the anterior pituitary gland. One of the challenges in optimizing GH therapy is improving adherence. Using digital interventions may overcome barriers to optimum treatment delivery. Massive open online courses (MOOCs), first introduced in 2008, are courses made available over the internet without charge to a large number of people. Here, we describe a MOOC aiming to improve digital health literacy among healthcare professionals managing patients with GHD. Based on pre- and post-course assessments, we evaluate the improvement in participants’ knowledge upon completion of the MOOC. Methods The MOOC entitled ‘Telemedicine: Tools to Support Growth Disorders in a Post-COVID Era’ was launched in 2021. It was designed to cover 4 weeks of online learning with an expected commitment of 2 h per week, and with two courses running per year. Learners’ knowledge was assessed using pre- and post-course surveys via the FutureLearn platform. Results Out of 219 learners enrolled in the MOOC, 31 completed both the pre- and post-course assessments. Of the evaluated learners, 74% showed improved scores in the post-course assessment, resulting in a mean score increase of 21.3%. No learner achieved 100% in the pre-course assessment, compared with 12 learners (40%) who achieved 100% in the post-course assessment. The highest score increase comparing the pre- and the post-course assessments was 40%, observed in 16% of learners. There was a statistically significant improvement in post-course assessment scores from 58.1 ± 18.9% to 72.6 ± 22.4% reflecting an improvement of 14.5% ( p   & lt; 0.0005) compared to the pre-course assessment. Conclusion This “first-of-its-kind” MOOC can improve digital health literacy in the management of growth disorders. This is a crucial step toward improving the digital capability and confidence of healthcare providers and users, and to prepare them for the technological innovations in the field of growth disorders and growth hormone therapy, with the aim of improving patient care and experience. MOOCs provide an innovative, scalable and ubiquitous solution to train large numbers of healthcare professionals in limited resource settings.
    Type of Medium: Online Resource
    ISSN: 2296-2565
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2023
    detail.hit.zdb_id: 2711781-9
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  • 9
    In: JMIR mHealth and uHealth, JMIR Publications Inc., Vol. 10, No. 1 ( 2022-1-20), p. e32626-
    Abstract: Recombinant human growth hormone (rhGH) therapy is an effective treatment for children with growth disorders. However, poor outcomes are often associated with suboptimal adherence to treatment. Objective The easypod connected injection device records and transmits injection settings and dose data from patients receiving rhGH. In this study, we evaluated adherence to rhGH treatment, and associated growth outcomes, in Latin American patients. Methods Adherence and growth data from patients aged 2-18 years from 12 Latin American countries were analyzed. Adherence data were available for 6207 patients with 2,449,879 injections, and growth data were available for 497 patients with 2232 measurements. Adherence was categorized, based on milligrams of rhGH injected versus milligrams of rhGH prescribed, as high (≥85%), intermediate ( 〉 56%- 〈 85%), or low (≤56%). Transmission frequency was categorized as high (≥1 per 3 months) or low ( 〈 1 per 3 months). Chi-square tests were applied to study the effect of pubertal status at treatment start and sex on high adherence, and to test differences in frequency transmission between the three adherence levels. Multilevel linear regression techniques were applied to study the effect of adherence on observed change in height standard deviation score (∆HSDS). Results Overall, 68% (4213/6207), 25% (n=1574), and 7% (n=420) of patients had high, intermediate, and low adherence, respectively. Pubertal status at treatment start and sex did not have a significant effect on high adherence. Significant differences were found in the proportion of patients with high transmission frequency between high (2018/3404, 59%), intermediate (608/1331, 46%), and low (123/351, 35%) adherence groups (P 〈 .001). Adherence level had a significant effect on ∆HSDS (P=.006). Mean catch-up growth between 0-24 months was +0.65 SD overall (+0.52 SD in patients with low/intermediate monthly adherence and +0.69 SD in patients with high monthly adherence). This difference translated into 1.1 cm greater catch-up growth with high adherence. Conclusions The data extracted from the easypod Connect ecosystem showed high adherence to rhGH treatment in Latin American patients, with positive growth outcomes, indicating the importance of connected device solutions for rhGH treatment in patients with growth disorders.
    Type of Medium: Online Resource
    ISSN: 2291-5222
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2022
    detail.hit.zdb_id: 2719220-9
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  • 10
    Online Resource
    Online Resource
    Frontiers Media SA ; 2021
    In:  Frontiers in Pediatrics Vol. 9 ( 2021-5-13)
    In: Frontiers in Pediatrics, Frontiers Media SA, Vol. 9 ( 2021-5-13)
    Abstract: Children born small for gestational age (SGA) comprise a heterogeneous group due to the varied nature of the cause. Approximately 85–90% have catch-up growth within the first 4 postnatal years, while the remainder remain short. In later life, children born SGA have an increased risk to develop metabolic abnormalities, including visceral adiposity, insulin resistance, and cardiovascular problems, and may have impaired pubertal onset and growth. The third “360° European Meeting on Growth and Endocrine Disorders” in Rome, Italy, in February 2018, funded by Merck KGaA, Germany, included a session that examined aspects of short children born SGA, with three presentations followed by a discussion period, on which this report is based. Children born SGA who remain short are eligible for GH treatment, which is an approved indication. GH treatment increases linear growth and can also improve some metabolic abnormalities. After stopping GH at near-adult height, metabolic parameters normalize, but pharmacological effects on lean body mass and fat mass are lost; continued monitoring of body composition and metabolic changes may be necessary. Guidelines have been published on diagnosis and management of children with Silver-Russell syndrome, who comprise a specific group of those born SGA; these children rarely have catch-up growth and GH treatment initiation as early as possible is recommended. Early and moderate pubertal growth spurt can occur in children born SGA, including those with Silver-Russell syndrome, and reduce adult height. Treatments that delay puberty, specifically metformin and gonadotropin releasing hormone analogs in combination with GH, have been proposed, but are used off-label, currently lack replication of data, and require further studies of efficacy and safety.
    Type of Medium: Online Resource
    ISSN: 2296-2360
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2021
    detail.hit.zdb_id: 2711999-3
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