Adherencia al tratamiento con somatotropina administrada con dispositivo electrónico

Vela, María Auxiliadora Arrabal; Gijón, C.; Martin, María Pascual; Giménez, Isabel; Águila, Vera Áreas del; Muñoz‐Rodríguez, José Ramón; Palomo-Atance, Enrique

doi:10.1016/j.endinu.2018.02.003

Cited by 7 publications

(6 citation statements)

References 16 publications

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“…In the present study, the observed adherence rate was above 80% up to 3 years of clinical follow-up, which contrasts with the expected adherence rate of 55–65% observed in other studies using different r-hGH delivery technologies [ 22 , 23 ] and confirms the findings of other reports with the same methodology [ 5 , 6 , 13 , 14 , 24 ]. Additionally, this study suggests that adherence to therapy is predictor of clinical response, a factor that has been described in other scenarios where electromechanical auto-injectors are used to deliver drugs and to assess compliance to therapy [ 25 − 30 ].…”

Section: Discussioncontrasting

confidence: 68%

Adherence to treatment in children with growth hormone deficiency, small for gestational age and Turner syndrome in Mexico: results of the Easypod™ connect observational study (ECOS)

Blanco-López

Antillón-Ferreira

Saavedra-Castillo³

et al. 2020

J Endocrinol Invest

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Background Assessing adherence to growth hormone (GH) is challenging. The Easypod™ connect device delivers preset doses of recombinant human GH (r-hGH) and stores a digital record of adherence that can be shared with healthcare provider. We assessed adherence to r-hGH delivered with Easypod™ according to the approved pediatric indications for r-hGH: growth hormone deficiency (GHD), born small for gestational age (SGA) who failed to show catch-up growth and Turner syndrome (TS). Methods ECOS (NCT01555528) was a multicenter (24 countries), 5-year, longitudinal, observational study, which aimed to evaluate country-specific adherence to r-hGH therapy prescribed via the Easypod™ electronic injection device. The primary endpoint was yearly adherence. Secondary endpoints were height velocity, height velocity standard deviation scores (SDS), height, height SDS and IGF-1 concentrations. Clinical and auxological data were obtained from medical records and adherence from Easypod™ logs. Results This study included 147 Easypod™-naïve Mexican children assessed during 3 years (mean age: 9.96 ± 3.41 years, 56.8% boys, mean height SDS at baseline: − 2.17 ± 0.97): 118 with GHD, 24 SGA and 5 with TS. A total of 105 (71.4%) patients were GH naïve. Overall median adherence was > 90% over the first year of treatment and > 80% at 3 years. Adherence was not different by r-hGH indication or between GH-naïve or experienced patients. At 1-year follow-up, mean change in height SDS was 0.57 ± 0.34, whereas mean height velocity SDS was 2.85 ± 2.51. In all, 84.7% patients had normal IGF-1 concentrations at 1-year follow-up. Adherence was associated with change in height SDS (r = 0.239, p = 0.005) and height velocity SDS (r = 0.194, p = 0.027). Conclusion Adherence rates with the Easypod™ device are high and maintained over time in GHD, SGA and TS Easypod™naïve Mexican patients. High adherence is associated with better outcomes. Easypod™ assists physicians in monitoring adherence to r-hGH.

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Section: Discussioncontrasting

confidence: 68%

Adherence to treatment in children with growth hormone deficiency, small for gestational age and Turner syndrome in Mexico: results of the Easypod™ connect observational study (ECOS)

Blanco-López

Antillón-Ferreira

Saavedra-Castillo³

et al. 2020

J Endocrinol Invest

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“…Despite these results, only electronic devices can provide a precise and objective measure of adherence (13, 15). To our knowledge, there are scarce studies specifically designed to measure adherence by using the electronic device, easypod™ (21, 22, 23, 24, 25, 26). Recently, the ECOS study (global, i.e.…”

Section: Discussionmentioning

confidence: 99%

Adherence and long-term outcomes of growth hormone therapy with easypod™ in pediatric subjects: Spanish ECOS study

Arnao

Sánchez

Díez-López

et al. 2019

Endocrine Connections

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Background Non-adherence to r-hGH treatments occurs in a variable percentage of subjects. One problem found when evaluating adherence is the great variability in methods of detection and definitions utilized in studies. This study assessed the level of adherence in subjects receiving r-hGH with the easypod™ electronic device. Methods National, multicenter, prospective and observational study involving 238 subjects (144 with GH deficiency (GHD), and 86 with small for gestational age (SGA), 8 with Turner Syndrome), who received r-hGH with easypod™ for at least 3 months before inclusion. The follow-up period was 4 years. Results Overall adherence was 94.5%; 97.5% after 6 months, 95.3% after 1 year, 93.7% after 2, 94.4% after 3 and 95.5% after 4 years of treatment. No differences in adherence were observed between prepubertal and pubertal groups and GHD and SGA groups. Change in height after 1 and 2 years, change in height SDS after 1 and 2 years, HV after 1 year, HV SDS after at 1 and 4 years, change in BMI after 1 year and change in BMI SDS at 1 and 2 years showed significant correlation with adherence. No significant differences in adherence according to IGF-I levels were found in follow-up visits or between groups. Conclusions The easypod™ electronic device, apart from being a precise and objective measure of adherence to r-hGH treatment, allows high compliance rates to be achieved over long periods of time. Adherence significantly impacts growth outcomes associated with r-hGH treatment.

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“…This treatment requires a daily subcutaneous injection over a period of several years, and is most often required by very young children (5,6). The condition being treated does not pose a threat to the patient's life or overall health and the benefits of the treatment are not seen immediately, and this can reduce the motivation needed to comply fully with the therapeutic regimen by the patients or their parents or carers (6,7). Daily injections may be seen as burdensome by both the young patient and their family (7,8) and, in many countries, the cost of r-hGH treatment and access to treatment are barriers to full adherence (9).…”

Section: Introductionmentioning

confidence: 99%

“…Measurement of adherence to treatment has previously only been possible by proxy methods, based on estimates from questioning and observation of patients, medication diaries, or monitoring of prescriptions filled or vials returned (1,9,10). These different methodologies explain the variable nature of available data on adherence to treatment with r-hGH (7,9). Studies that have assessed therapeutic adherence indirectly, through questionnaires addressed to patients or parents, report that between 48.0 and 78.7% of patients have "good" adherence to the injection of r-hGH (7).…”

Section: Introductionmentioning

confidence: 99%

“…These different methodologies explain the variable nature of available data on adherence to treatment with r-hGH (7,9). Studies that have assessed therapeutic adherence indirectly, through questionnaires addressed to patients or parents, report that between 48.0 and 78.7% of patients have "good" adherence to the injection of r-hGH (7). However, it is important to note that this measurement method depends on the reliability of the patient/parent and their recall, which frequently results in an overestimation of adherence (7,11).…”

Section: Introductionmentioning

confidence: 99%

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Positive Impact of Targeted Educational Intervention in Children With Low Adherence to Growth Hormone Treatment Identified by Use of the Easypod™ Electronic Auto-injector Device

Assefi

Roca

Rubstein

et al. 2021

Front. Med. Technol.

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Background: It is important to identify patients with low adherence to recombinant human growth hormone (r-hGH) therapy and initiate actions to improve adherence. The Merck Patient Support Program (PSP) aims to raise the awareness of these patients and their parents of the importance of good adherence in achieving optimal growth outcomes. The easypod™ digitally-enhanced injection device provides accurate, reliable adherence data for the PSP by recording the exact dose, time and date of injections given. In this study, we aimed to measure the effect of an educational intervention on adherence in patients using the easypod™ device to deliver their r-GH therapy.Methods: This was a 12-month observational, retrospective cohort study. Patients previously identified by data recorded from their easypod™ injection device as having low adherence (<80%) were followed over the 6 months before and after a targeted educational visit by a PSP nurse. Patient adherence and demographic data were extracted from the PSP database. Statistical analyzes were carried out with STATA 15.0 software.Results: Data from 80 patients (65% male) with low adherence were analyzed. Patients were aged 2–18 (mean: 11.77) years with diagnoses of growth hormone deficiency (71.25%), small for gestational age (20%), Turner syndrome (7.50%) and chronic renal disease (1.25%). Duration of treatment was 0.40–11.13 (median: 3.62) years. At baseline, median adherence to r-hGH therapy was 67%; after the intervention it increased to 76%, a statistically significant median improvement of 9% (p = 0.0000, Wilcoxon signed-rank test). Additionally, 36% (29/80) of patients increased their adherence to r-hGH therapy to ‘good’ (≥80%). Both changes were clinically relevant.Conclusions: We conclude that a nurse-led educational intervention, supported by digital medication adherence monitoring, is a simple method to improve adherence to r-hGH therapy, and recommend this intervention to reduce the gap between the indication/recommendation of the specialist and patients' behavior.

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Adherencia al tratamiento con somatotropina administrada con dispositivo electrónico

Cited by 7 publications

References 16 publications

Adherence to treatment in children with growth hormone deficiency, small for gestational age and Turner syndrome in Mexico: results of the Easypod™ connect observational study (ECOS)

Adherence to treatment in children with growth hormone deficiency, small for gestational age and Turner syndrome in Mexico: results of the Easypod™ connect observational study (ECOS)

Adherence and long-term outcomes of growth hormone therapy with easypod™ in pediatric subjects: Spanish ECOS study

Positive Impact of Targeted Educational Intervention in Children With Low Adherence to Growth Hormone Treatment Identified by Use of the Easypod™ Electronic Auto-injector Device

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