Monitoring of treatment adherence with easypod™ in six Italian centers: a real-world experience

Cardinale, G; Pesce, Sabino; Ingletto, Dario; Mariano, Matteo; Catucci, Alessandra; Corciulo, Nicola; Fidotti, Enrico

doi:10.23736/s0391-1977.18.02843-2

Cited by 2 publications

(6 citation statements)

References 12 publications

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“…The mean age of patients among the 17 rhGH studies that reported age ranged from 6 years (for patients receiving daily rhGH) (14) to 12.3 years (15). A total of 6 (26%) studies were from Italy (11,(16)(17)(18)(19)(20), five (22%) were from multiple countries (13, 14, 21-23), and three (13%) were from Spain (4,12,24). The remaining nine studies were each from a different country (15,(25)(26)(27)(28)(29)(30)(31)(32).…”

Section: Study Characteristicsmentioning

confidence: 99%

“…In addition to the six ECOS, there were five other studies that used easypod to collect adherence data; three from Italy (17,19,20), one from Spain (12), and one large multi-country study of 13,553 patients described above (13). All were retrospective studies except for one by Loche et al (19), which was a prospective observational study.…”

Section: Easypod Connect Observational Study (Ecos) and Other Easypod...mentioning

confidence: 99%

“…All were retrospective studies except for one by Loche et al (19), which was a prospective observational study. Of the three studies that reported mean adherence rate, values ranged from 70% ± 13% (time period not reported) (17) to 96% over 12 months (20).…”

Section: Easypod Connect Observational Study (Ecos) and Other Easypod...mentioning

confidence: 99%

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Treatment Adherence to Injectable Treatments in Pediatric Growth Hormone Deficiency Compared With Injectable Treatments in Other Chronic Pediatric Conditions: A Systematic Literature Review

et al. 2022

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BackgroundPediatric patients with growth hormone deficiency (GHD) are currently treated with daily injections of recombinant human growth hormone (rhGH) to promote linear growth and enable attainment of normal adult height. One of the main reasons for suboptimal growth during rhGH therapy is non-adherence to treatment. The objective of this systematic literature review was to examine the recent literature on pediatric adherence to injectable treatments for chronic conditions (focusing on rhGH) to characterize levels of adherence and identify the factors/barriers associated with adherence.MethodsThe Embase and MEDLINE databases (January 2015–October 2020) were searched to identify publications describing studies of pediatric patients (aged ≤17 years) with GHD and other chronic conditions requiring daily or weekly injectable treatments; a similar targeted search of Chinese literature was also performed. Adherence data were extracted from the included studies and summarized. Risk of bias was determined using the Cochrane Risk of Bias tool 2 or the Newcastle-Ottawa Scale.ResultsA total of 23 publications were included, with all publications except for one (multiple sclerosis) focused on pediatric GHD studies: there were two clinical trials, 18 observational studies and three survey studies. Study sample sizes ranged from 30 to 13,553 patients (median: 95 patients). The definition of adherence varied between studies and included mean adherence rate, median adherence rate, and the percentage of patients within pre-specified adherence categories. Of the publications assessing adherence to daily rhGH, 11 studies reported 12-month mean adherence rate (range: 73.3%– 95.3%) and eight studies reported median adherence (range: 91%– 99.2%). The barriers to treatment adherence identified included self-administration, increased administration frequency, age (adolescence), longer treatment duration, device design, and insufficient family education, awareness, and/or engagement. Recommendations for increasing adherence included using adherence reminder tools, increasing patient engagement/education, and improving injection device design and drug product.ConclusionsAdherence to rhGH treatment was high (>80%) for many studies, though comparability between studies was limited given the substantial heterogeneity in the way adherence was defined, measured, and reported. To address this heterogeneity, we recommend standardizing how adherence is defined and reported and encourage the use of standardized study designs and outcome measures.

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Section: Study Characteristicsmentioning

confidence: 99%

Section: Easypod Connect Observational Study (Ecos) and Other Easypod...mentioning

confidence: 99%

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Treatment Adherence to Injectable Treatments in Pediatric Growth Hormone Deficiency Compared With Injectable Treatments in Other Chronic Pediatric Conditions: A Systematic Literature Review

et al. 2022

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“…To address research question 2 (adherence), we identified 10 studies [6, 8-12, 18, 20, 22, 23], 5 of which report on adherence to GH treatment in general, using different approaches to assess adherence [6,9,10,18,23], and 5 studies describing the adherence with the Easypod™ device (Saizen1, Merck Serono S.A.-Geneva, Switzerland) [8,11,12,20,22], an electronic autoinjector that automatically records the patient's adherence to treatment. The characteristics of included studies are reported in Table 3.…”

Section: Adherencementioning

confidence: 99%

“…The paper by Cardinale et al [11] describes a multicenter study conducted in 6 Italian centers, with the aim of evaluating adherence to GH treatment in patients with growth deficiency, monitored using the Easypod ™ device. Adherence was defined as the ratio between actual days of treatment and planned days of treatment.…”

Section: Plos Onementioning

confidence: 99%

Pediatric growth hormone treatment in Italy: A systematic review of epidemiology, quality of life, treatment adherence, and economic impact

Orso¹,

Polistena

Granato

et al. 2022

PLoS ONE

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Objectives This systematic review aims to describe 1) the epidemiology of the diseases indicated for treatment with growth hormone (GH) in Italy; 2) the adherence to the GH treatment in Italy and factors associated with non-adherence; 3) the economic impact of GH treatment in Italy; 4) the quality of life of patients treated with GH and their caregivers in Italy. Methods Systematic literature searches were performed in PubMed, Embase and Web of Science from January 2010 to March 2021. Literature selection process, data extraction and quality assessment were performed by two independent reviewers. Study protocol has been registered in PROSPERO (CRD42021240455). Results We included 25 studies in the qualitative synthesis. The estimated prevalence of growth hormone deficiency (GHD) was 1/4,000–10,000 in the general population of children; the prevalence of Short Stature HOmeoboX Containing gene deficiency (SHOX-D) was 1/1,000–2,000 in the general population of children; the birth prevalence of Turner syndrome was 1/2,500; the birth prevalence of Prader-Willi syndrome (PWS) was 1/15,000. Treatment adherence was suboptimal, with a range of non-adherent patients of 10–30%. The main reasons for suboptimal adherence were forgetfulness, being away from home, pain/discomfort caused by the injection. Economic studies reported a total cost for a complete multi-year course of GH treatment of almost 100,000 euros. A study showed that drug wastage can amount up to 15% of consumption, and that in some Italian regions there could be a considerable over- or under-prescribing. In general, patients and caregivers considered the GH treatment acceptable. There was a general satisfaction among patients with regard to social and school life and GH treatment outcomes, while there was a certain level of intolerance to GH treatment among adolescents. Studies on PWS patients and their caregivers showed a lower quality of life compared to the general population, and that social stigma persists. Conclusion Growth failure conditions with approved GH treatment in Italy constitute a significant burden of disease in clinical, social, and economic terms. GH treatment is generally considered acceptable by patients and caregivers. The total cost of the GH treatment is considerable; there are margins for improving efficiency, by increasing adherence, reducing drug wastage and promoting prescriptive appropriateness.

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Monitoring of treatment adherence with easypod™ in six Italian centers: a real-world experience

Cited by 2 publications

References 12 publications

Treatment Adherence to Injectable Treatments in Pediatric Growth Hormone Deficiency Compared With Injectable Treatments in Other Chronic Pediatric Conditions: A Systematic Literature Review

Treatment Adherence to Injectable Treatments in Pediatric Growth Hormone Deficiency Compared With Injectable Treatments in Other Chronic Pediatric Conditions: A Systematic Literature Review

Pediatric growth hormone treatment in Italy: A systematic review of epidemiology, quality of life, treatment adherence, and economic impact

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