Compliance to Growth Hormone Therapy in Children and Adolescents with Growth Hormone Deficiency and Turner Syndrome and Impact on Height Velocity: A Prospective Study (original) (raw)
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Non-Compliance with Growth Hormone Treatment in Children Is Common and Impairs Linear Growth
PLoS ONE, 2011
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 fourmonth 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 6 SEM. Findings: 177 patients were receiving GH in the study period, aged 12.160.6 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.
Journal of Endocrinological Investigation, 2020
Background Assessing adherence to growth hormone (GH) is challenging. The Easypod™ connect device delivers pre-set 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. Result...
Adherence to Growth Hormone Therapy: A Practical Approach
Hormone Research in Paediatrics, 2014
Background: Early detection of suspected poor adherence to growth hormone (GH) therapy is crucial to achieve normal final height in GH-deficient (GHD) patients. Patients: 106 children (73 M, 33 F) with a median age of 10.47 ± 3.48 years (mean ± standard deviation score (SDS)) exhibited short stature (-1.76 ± 0.64 SDS) and a delayed bone age (8.68 ± 3.42 years). Severe GHD was found in 28, while partial GHD was seen in 78 cases, with low IGF-I values. Recombinant human GH was administered by daily subcutaneous injection at a dosage of 21 μg/kg in prepubertal and 25 μg/kg in pubertal patients. Results: Poor adherence was suspected in a number of patients, but clearly demonstrated in only 4 cases with persistent reduced height velocity in spite of a corrected therapeutic regimen. These patients admitted incomplete adherence to GH injections and clinical and anthropometric measurements revealed their poor response to therapy. Conclusions: To efficaciously improve adherence in GHD patients, it is mandatory to regularly interview patients; a non-aggressive approach might be utilized to ensure effective communication with patients and their parents.
Adherence in children with growth hormone deficiency treated with r-hGH and the easypod™ device
Journal of endocrinological investigation, 2016
Poor 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. Ninety-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, ad...
Adherence to growth hormone therapy in children and its potential barriers
Journal of pediatric endocrinology & metabolism : JPEM, 2018
One of the main concerns in chronic diseases such as growth hormone (GH) deficiency is adherence to the treatment, which significantly affects treatment outcomes. This cross-sectional study was conducted among 169 GH recipient children (2-12 years) and teens (13-19 years) referred to a GH distributing teaching pharmacy. The eight-item Morisky Medication Adherence Scale (MMAS) and auto-compliance method were used for the assessment of patients' adherence to GH. The potential barriers to GH therapy adherence and medication persistence were also explored. Based on the MMAS method, 56.7% of the children and 57.9% of the adolescent groups were adherent to GH therapy. Conversely, according to the auto-compliance method almost all the patients were adherent in the children (95.2%) and adolescent (95.5%) groups. Forgetting to take the injection or refill the prescription, being away from home, exhaustion from long-term injection, drug shortage and inaccessibility to the pharmacy were ba...
Сompliance and Barriers to Growth Hormone Therapy in Children
Pediatria Polska, 2021
Aim: To compare the level of compliance to recombinant human growth hormone (rGHh) therapy depending on the methods of its measuring and identify social/demographic, cognitive/emotional and medical factors (barriers) that influence adherence to treatment of children with growth hormone deficiency (GHD). Material and methods: The study group included 80 children with GHD at the age of 7.1 ±0.4 years. The assessment of adherence to rGHh therapy was carried out by the self-report method and the Morisky Medication Adherence Scale (MMAS). Social/demographic, cognitive/emotional, and medical factors were considered as potential barriers compliance. The categorical variables were expressed as frequency (percentage) and analyzed by χ 2-test. A p-value < 0.05 was considered as statistically significant. Results: Comparison of two methods of measuring adherence to rGHh therapy demonstrates the advantages of using the MMAS. The self-report method overestimates the compliance. Children with unacceptable adherence were more likely to have such social/demographic factors as below average income, rGHh shortage and being away from home. Cognitive/emotional barriers to compliance included forgetfulness/ preoccupation, fear of injections, and treatment fatigue. Medical factors that impeded the development of acceptable compliance included insufficient patient/parents counseling, use of conventional syringe instead of automatic pen devices. Implementation of the compliance support program increased the frequency of acceptable (high and medium) adherence to rGHh therapy to 80.0% compared to the baseline level of 57.4% (p = 0.002). Conclusions: Adequate assessment of compliance to rGHh therapy depends on the choice of measurement method. An individual compliance support program based on the results of identification of barriers contributes to an increase in the adherence to rGHh therapy in children with GHD.
Tikrit Medical Journal, 2010
The use of growth hormone (GH) in clinical endocrine practice is expanding and its role in the treatment of various clinical conditions is increasingly appreciated. Concurrently, concerns have been raised about the ethnical, economic, safety and efficacy of growth hormone and this study in this direction. This study is conducted to determine the growth response to growth hormone(GH) therapy in growth hormone deficient patients(GHD) either partial or complete selected from those who registered in pediatric endocrinology clinic at Central Teaching Hospital for Children in Baghdad and the effect of other factors as age, gender, birth weight, chronological bone age…..etc. A prospective study was conducted on 160 patients with age 3-12 years selected from 1400 patients with age 1-18 years registered in pediatric endocrinology clinic at central teaching hospital for children presented with short stature subjected to full physical examination preceded by medical history and accurate measurements including parents then they screened for causes of short stature including hormonal ,chromosomal and radiological assay to confirm the growth hormone deficiency after that treated with recombinant growth hormone from 1st June 2008 and 1st December 2008 during this period the patients followed monthly according to filing system. The height velocity before treatment was 3.5±1.2cm/y after 6 months of therapy was 8.5±3.6cm/y.There was no significant difference in the height velocity regarding the sex, age, partial or complete GHD and the degree of the bone age delay in contrast to birth weight which had significant positive correlation with height velocity response among of 160 patients 136 (85%) achieved adequate response. This study indicates a significant response in linear growth in patients with GHD after treatment with recombinant GH with positive relationship with birth weight so effort & resources needed to achieve availability of the drug, related equipments, laboratory tests & trained personnel. This study is preliminary one and we hope further expanded studies in this subject in the future.
Clinical Endocrinology, 2011
Objective To investigate response to growth hormone (GH) in the first, second and third years of treatment in the total clinical cohort of Turner syndrome (TS) patients in Australia. Context Short stature is the most common clinical manifestation of TS. GH treatment improves growth. Design Response was measured for each year of treatment. Stepwise multiple regression analyses were used to identify factors that significantly influenced response. Patients Prepubertal TS patients who completed 1 year (n = 176), 2 year (n = 148), or 3 year (n = 117) of treatment and were currently receiving GH. Measurements Change in TS specific Height Standard Deviation Score (DTSZ) was the main response variable used. Major influencing variables considered included dose, starting age and height, BMI, bone age delay, karyotype, parental height, and interactions between dose and starting age or height. Results Response was greatest in first year and declined thereafter (median DTSZ: 1st year = +0AE705, 2nd year = +0AE439, 3rd year = +0AE377) despite the median dose increasing [1st year = 5AE5 mg/m 2 /week (0AE23 mg/kg/week), 2nd year = 6AE4(0AE24), 3rd year = 7AE2(0AE26)]. An Age*Dose interaction was identified influencing first, second year, and total DTSZ. The DTSZ over 3 years was significantly influenced by first-year dose. Dose increments only attenuated the general decline in response. An acceptable firstyear response (DTSZ > 1AE01) was achieved by only 17AE6% of patients. Conclusions Growth response is greatest and most influenced by dose in the first year. Dose in first year is a major factor contributing to total response. A starting Age*Dose interaction effect was observed such that young girls on a high dose respond disproportionately better. Optimal GH treatment of short stature in TS thus requires early initiation with the highest safe dose in the first year.