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IntroductionWhile reasons for non-adherence in children requiring growth hormone (GH) replacement (GH-Rx) are well researched, few studies have investigated adherence in adult GH deficient patients. Against the background of the adverse medical sequelae of untreated severe GH deficiency (GHD) in adults, we explored adherence to GH-Rx and associated...
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Context 1
... were calculated, if variances were equal in the subgroups. If variances differed, the more robust Brown-Forsythe test was used. Nominal data were analyzed by chi-square test or, if expected frequencies were below 5, Fisher's exact test. A visual screening of the histogram revealed a severe skewness of the rhGH-specific adherence score (cf. Fig. 1). Therefore, for correlation analyses including this score, the non-parametric Spearman's Rho coefficient was used. For variables containing free text options (i.e. Other reasons for leaving out an injection), the answers were categorized and counted. Where applicable, a p-value of ≤ 0.05 was regarded as statistically ...
Context 2
... mean rhGH-specific Adherence Score in the treatment group was 15.8 ± 2.0 with a minimum of 9 and a maximum of 18. The distribution of adherence scores was severely skewed (cf. Fig. 1) 66.4% of the patients (n = 71) stated, that taking rhGH regularly was very important to them (cf. Fig. 2). 78.5% of the patients (n = 84) stated that their motivation to take rhGH was their physician's advice to take it. Improving their physical capacity was the motivation for 63.6% (n = 68) and improving their mental capacity ...
Citations
... Furthermore, a small but significant number of patients choose to stop their GH injections due to a perceived lack of benefit from this treatment, side effects, concerns about long-term safety or due to the burden of the daily subcutaneous administration 3,[13][14][15] . Additionally, treatment of adults with GHD is associated with considerable health care costs. ...
... Experience of side effects and poor concordance with the daily injections were the second and third most indicated reasons. These findings are in accord with previous literature reporting that the perception of minimal therapeutic benefit, the fear of side effects and concerns on long-term safety, alongside the dislike of daily injections are the most frequent reasons for which adults with GHD stop their treatment 3,13,15 . Patients' fear of needles was also noted, although not as prominent as other factors. ...
... In comparison with consultant endocrinologists, fewer nurses indicated patients' fear of side effects or of needles as the main reasons. The limited qualitative studies investigating adherence with GH specifically in adults report that patient education incorporating information about potential positive therapeutic effects increases concordance with treatment and promotes self-empowerment 15,29 . Patient education is typically the remit of nurses who usually recognise this specific role as having a positive impact on adherence with treatment. ...
Objective: We conducted a survey of UK endocrine clinicians between 06/2022 and 08/2022 to understand current practices regarding GH treatment discontinuation in adults with GH deficiency (GHD).
Design and Methods: Using Survey Monkey®, a web-based multiple-choice questionnaire was disseminated to the UK Society for Endocrinology membership. It consisted of 15 questions on demographics, number of patients receiving GH and current practice on GH treatment discontinuation.
Results: 102 endocrine clinicians completed the survey; 65 respondents (33 endocrinologists and 32 specialist nurses) indicated active involvement in managing patients with GHD. 27.7% of clinicians were routinely offering a trial of GH discontinuation to adults receiving long-term GH therapy. Only 6% had a clinical guideline to direct such practice. 29.2% stated that GH discontinuation should be routinely offered as an option to patients on long-term treatment; 60% were not clearly in favour or against this approach but stated that it should probably be considered, whilst 9.2% were against. During the GH withdrawal period, most clinicians monitor signs/symptoms (75.4%), measure IGF-1 (84.6%) and complete a quality of life assessment (89.2%).
Conclusions: The practice of offering a trial of GH discontinuation in GHD adults on long-term GH therapy is highly variable reflecting the lack of high quality evidence. Around a quarter of clinicians offer GH withdrawal for a number of reasons, but only a few have a local clinical guidance. A further 60% of clinicians stated they would probably consider such an approach. Methodologically sound studies underpinning the development of safe and cost-effective guidance are needed.
... 5,6 Both studies found that a high proportion of children discontinued treatment despite exhibiting early persistence. 5,6 For adults with GHD (AGHD), adherence to daily GH among 107 participants was investigated using a cross-sectional analysis, 7 and the results showed that older age was significantly associated with better adherence to daily GH (p = 0.021). 7 Given trends seen in other chronic conditions requiring long-term treatment, it is likely that the high injection frequency plays a role in the increasingly low adherence to daily GH. ...
... 5,6 For adults with GHD (AGHD), adherence to daily GH among 107 participants was investigated using a cross-sectional analysis, 7 and the results showed that older age was significantly associated with better adherence to daily GH (p = 0.021). 7 Given trends seen in other chronic conditions requiring long-term treatment, it is likely that the high injection frequency plays a role in the increasingly low adherence to daily GH. 4,8 To address this shortcoming of sub-optimal adherence with daily GH administration, long-acting growth hormones (LAGHs) have been studied, most of which are administered once weekly (Table 1). ...
Growth hormone (GH) replacement therapy for growth hormone deficiency (GHD) in children and adults has for over 25 years, until recently, been administered as daily injections. This daily treatment regimen often incurs a burden to patients and caregivers, leading to high rates of non-adherence and, consequently, decreased treatment efficacy outcomes. To address this shortcoming, long-acting growth hormones (LAGHs) have been developed with the aim of reducing the burden of daily injections, thereby potentially improving treatment adherence and outcomes. Somapacitan (Sogroya®) (Novo Nordisk, Bagsværd, Denmark) is a LAGH currently approved for the treatment of adult and childhood GHD (AGHD and CGHD, respectively) in several countries. Other LAGHs, such as somatrogon (Ngenla®) (Pfizer, New York, United States) and lonapegsomatropin/TransCon GH (Skytrofa®) (Ascendis Pharma, Copenhagen, Denmark), are also currently approved and available for the treatment of CGHD in several countries. In this review, we will consider the method of protraction, pharmacokinetics (PK) and pharmacodynamics (PD), efficacy, and safety results of somapacitan in adult and pediatric trials and how these characteristics differ from those of the other aforementioned LAGHs. Additionally, the administration of somapacitan and timing of measurement of serum insulin-like growth factor-I (IGF-I) levels are summarized. Information on administration, advice on missed doses, and clinical guidelines are discussed, as well as identifying which patients are suitable for somapacitan therapy, and how to monitor and adjust dosing whilst on therapy.
... A number of pediatric studies demonstrate that adherence to GH treatment is suboptimal, with some degree of non-adherence in up to 71% of all pediatric patients and their families as reported in a recent review (8). Preliminary data of Amereller et al. and our group indicate that adherence of aGHD patients to GHRx is higher than in children and adolescents (9,10). Nevertheless, in clinical practice, a number of aGHD patients decide to refuse recombinant human (rh)GH treatment or to discontinue rhGH therapy over time. ...
... Patients with known active psychotic illnesses and known insufficient fluency of the German language were excluded from participation. A detailed study description and a description of the entire sample of investigated patients have been published previously (10). ...
... For the present research question, a battery of psychological self-rating inventories covering the three domains outlined in the introduction, thought to impact on adherence, was analyzed in the large subgroup of patients on rhGH replacement (n = 107) at the time of the study. The questionnaire results were related to the patients' adherence to medication in general and to adherence to GHRx, the results of which have been reported previously (10). ...
Introduction
Little is known about psychological reasons associated with adherence to growth hormone (GH) replacement therapy (GHRx) in adults. As in other chronic diseases, medication-related beliefs, coping strategies and disease impact on quality of life (QoL) might play an important role. We thus explored these psychological factors in relation to adherence in patients with GH deficiency (GHD) in order to find leverage points for the improvement of adherence.
Patients and Methods
Cross-sectional analysis including 107 adult GHD patients on GHRx who completed self-assessment inventories on health-related QoL (Short-Form SF-36), coping style (Freiburg questionnaire on coping with illness, FKV-LIS) and medication beliefs (Beliefs about Medicine questionnaire, BMQ). Results were correlated to general and GH-specific adherence to medication.
Results
In the BMQ, 92.5% of the patients (n=99) reported a strong belief in the need for their medication, which correlated significantly with general adherence (rs = 0.325). Active coping was significantly related to general (rs = 0.307) and GH-specific adherence (rs = 0.226). Better mental QoL (rs = 0.210) but worse physical QoL (rs = -0.198; all p < 0.05) were related to higher GH-specific adherence. Older age was associated with a higher degree of active coping, a higher belief in the necessity of medication and worse physical QoL.
Conclusion
We provide preliminary data that most GHD patients on GHRx are strongly convinced of their need for medication and that adherence to GHRx is influenced by coping strategies and QoL. Patients with impaired psychological QoL are less able to translate their convictions into good adherence, a phenomenon to be addressed in future research.
... option for individual patients, and might be particularly important in children to improve adherence (3). ...
... Present rates are similar or even higher than those previously reported, especially in paediatric patients, and that is a remarkable point. Overnight trips or being away from home have been reported as frequent reasons for skipping injections both in children and adults (3,9). Hence, the unusual situation of being confined at home due to the Covid pandemic might be hypothesized as a possible aspect influencing the high adherence rate recorded here. ...
Due to the outbreak of Covid-2019 pandemic, the organisation of many Hospitals in Italy, as well as all over the world, has changed dramatically. In our tertiary Endocrinology Unit, we are continuing to deliver urgent care to our patients, trying to grant assistance to chronic and frail subjects, as well. In this Letter, we provide a picture of GH adherence during Covid19 pandemic form one of the first and worst hit Italian region. We aim to share our experience in the management of both paediatric and adult patients with growth hormone deficiency, enlightening that every possible effort is valuable to reduce the risk of therapy discontinuation.
Introduction
Non-compliance to recombinant human growth hormone (rhGH) treatment is universally recognized as a key detrimental factor to achieve the expected clinical outcomes in adult GH deficiency (aGHD). The Easypod™ electronic device allows objective measurement of adherence. Adherence to treatment has been reported to be related with IGF-1 levels and consequently with clinical satisfactory results. The aim of this multicentric, observational, retrospective, 24- month study, is to objectively assess aGHD patients’ compliance to rhGH, using the Easypod™ device. Additionally, the study aims to compare the biochemical responses of adherent vs non-adherent patients.
Methods
Forty-three patients (28 females and 15 males) affected by aGHD and equipped with Easypod™ from 3 Italian centers were included in the study. Adherence to treatment was defined as the proportion of injections correctly administered during the observational period, out of the expected total number of injections. All patients were evaluated for IGF-1, glucose, insulin, HOMA and QUICKI index, total/LDL/HDL cholesterol and triglycerides.
Results
Mean adherence rate was consistently under 85% across the 2-year observation period (73% at year 2). A trend toward significant difference in adherence was shown when comparing female and male patients (respectively 76% and 61%) after a 2-year period. Among the anamnestic features, the prescribed frequency of administration of rhGH and the number of administered therapies appeared to be the most relevant adherence-influencing factors. A strong direct correlation between IGF-1 z-score and adherence to rhGH therapy was detected in the whole population.
Discussion
Compliance to rhGH therapy is still a major issue in aGHD treatment. Adherence relates to therapy efficacy in aGHD. The use of Easypod™ could be beneficial for physicians to better manage aGHD patients and to achieve improved better biochemical and clinical responses.
Patients with adult growth hormone deficiency (AGHD) present with diverse clinical symptoms associated with impaired quality of life and an approximate 2-fold increase in mortality, as compared with the general population. As most acquired causes of AGHD are associated with neurosurgical disorders (e. g., hypothalamic and pituitary tumors, pituitary surgery, and cranial radiotherapy), an accurate diagnosis of severe AGHD in daily neurosurgical practice followed by hormone replacement therapy with daily or weekly recombinant human growth hormone (rhGH) injections is critical. To achieve this aim, AGHD should be suspected in patients with current or a history of intracranial disease, and a diagnosis of severe AGHD should be established with growth hormone (GH) stimulation testing. As patients who are diagnosed with AGHD after cranial surgery or radiotherapy may not be granted medical expense support for a designated intractable disease, preoperative GH stimulation testing is crucial to prove that the patient had AGHD before surgery or radiotherapy. For patients who have undergone surgery for craniopharyngioma or pituitary adenoma, outpatient follow-up (every 3-6 months) is recommended to monitor the GH secretion status. Understanding the characteristics of rhGH injections, including common adverse events, contraindications, and the need for dose titration, is crucial, and neurosurgeons should inform patients about the potential risks of tumor recurrence. Consensus among neurosurgeons for the treatment of AGHD is warranted, as are guidelines for collaboration among different specialties.
Pituitary conditions are associated with several physical, psychological, and social symptoms. Most patients with pituitary conditions have permanent hypopituitarism (congenital or acquired) and require lifelong hormone replacement therapy. Polypharmacy with complex treatment regimens, varied modalities and/or multiple daily dosing adds to the complexity of managing hypopituitarism. Nonadherence, treatment discontinuation and low persistence are often common for patients on pituitary replacement therapy. Medication-taking behavior is complex, and at times not exclusively the responsibility or within the control of the patient. Self-management skills and person-centered care are crucial for patients to optimize their hormone replacement therapy, to improve their well-being and quality of life, and to minimize adverse effects associated with hormone deficiency or overreplacement.
Nurses with specialist skills in Endocrinology working at an advanced practice level are key players in the pituitary multidisciplinary team to support patients’ self-management and treatment optimization. Endocrine nurses have a leading role in patient education and in the development and delivery of evidence-based and structured patient education programs. This chapter discusses how endocrine nurses use their advanced practice skills to support self-management and treatment optimization for patients with hypopituitarism. Approaches and strategies for patient education and adherence to treatment are also discussed with a focus on the nursing role. Each section is illustrated with patient case scenarios and good clinical practice examples.
Background
: Growth hormone (GH) treatment preference and adherence are affected by delivery device convenience, injection-site pain, confidence in correct dose administration, and satisfaction with the device. This survey investigated if switching device to NordiFlex® improved treatment experience in pediatric patients in South Korea.
Design and methods
: Patients aged 4–≤18 years were surveyed. Participants were NordiFlex® users who previously used NordiLet®/other devices. Participants compared preference, self-reported adherence, satisfaction, perceived ease of use, and device subjective benefits (across four domains: ease of use, self-efficacy, minimal disruption of daily life, positive feelings about injections) of NordiFlex® vs. previous device.
Results
: Ninety-four patients were enrolled, of which 91.5% previously used NordiLet®. Significantly more patients preferred, and were more satisfied with NordiFlex® vs. previous device; mean score: 0.65 (95% confidence interval [CI]:0.41;0.88) and 0.61 (95% CI:0.36;0.85), respectively. Participants reported greater perceived ease of use (0.49 [95% CI:0.26;0.72]) and fewer missed injections (0.20 [95% CI:0.06;0.34], with NordiFlex® vs. previous device. Bivariate analysis showed significant associations between preference for NordiFlex® and higher scores on self-efficacy, ease of use, minimal disruption of daily life, and positive feelings about injection (all p<0.001).
Conclusion
: These results suggest that improvements in device features could be associated with improved treatment experience.
