Evaluating the TUITEK® patient support program in supporting caregivers of children diagnosed with growth hormone deficiency in Argentina.

Introduction: 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 < 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.

Interventions Designed to Improve Adherence to Growth Hormone Treatment for Pediatric Patients and Their Families: A Narrative Review.

Even though growth hormone (GH) treatment is still the only active treatment option to correct growth failure and increase stature for patients with GH deficiencies, evidence has shown that non-adherence remains high. The aim of this review was to identify and review the existing interventional strategies that have been designed to address and improve adherence to GH treatment for pediatric patients and their families. An extensive search of several electronic databases was undertaken to identify relevant interventional studies, published in English, between 1985 and 2021. Additional search strategies included hand-searching topic review articles to identify eligible studies. Articles were screened against the inclusion eligibility criteria and data on sample characteristics, intervention features, and key findings was extracted. A total of fifteen interventional studies were included in the review. The interventions identified were divided into two broad categories: novel injection devices, and patient choice of device. In conclusions, this review acknowledges that there is a lack of evidence-based, theory-driven intervention strategies, designed with the purpose of optimizing treatment adherence and improve clinical and psychosocial outcomes.

Adherence to r-hGH Therapy in Pediatric Growth Hormone Deficiency: Current Perspectives on How Patient-Generated Data Will Transform r-hGH Treatment Towards Integrated Care.

Pediatric growth hormone (GH) deficiency is a licensed indication for replacement therapy with recombinant human growth hormone (r-hGH). Treatment, consisting of daily subcutaneous injections, extends from the time of diagnosis until cessation of linear growth at completion of puberty. Suboptimal adherence to r-hGH therapy is common and has been well documented to substantially impair the growth response and achievement of the optimal goal which is attainment of adult height within the genetic target range. The causes of poor adherence are complex and include disease-, patient-, doctor-, and treatment-related factors. Interventions for suboptimal adherence are important for a long-term successful outcome and can include both face-to-face and digital strategies. Face-to-face interventions include behavioral change approaches such as motivational interviewing and non-judgmental assessment. Medical and nursing staff require training in these techniques. Digital solutions are rapidly advancing as evidenced by the electronic digital auto-injector device, easypod® (Merck Healthcare KGaA, Darmstadt, Germany), which uses the web-based easypod® connect platform allowing adherence data to be transmitted electronically to healthcare professionals (HCPs), who can then access GH treatment history, enhancing clinical decisions. Over the past 10 years, the multi-national Easypod® Connect Observational Study has reported high levels of adherence (>85%) from up to 40 countries. The easypod® connect system can be supported by a smartphone app, growlink™, which facilitates the interactions between the patients, their care team, and patient support services. HCPs are empowered by new digital techniques, however, the human-digital partnership remains essential for optimal growth management. The pediatric patient on r-hGH therapy will benefit from these innovations to enhance adherence and optimize long-term response.

Investigating the Impact of the TUITEK® Patient Support Programme, Designed to Support Caregivers of Children Prescribed Recombinant Human Growth Hormone Treatment in Taiwan.

Purpose: Poor adherence to recombinant human growth hormone (r-hGH) treatment presents a significant barrier to achieving optimal growth outcomes. It is important to identify and address the treatment adherence-related needs of children prescribed r-hGH treatment, and develop new approaches to improve adherence. We aimed to measure the impact of the TUITEK® patient support programme, a multi-component personalized service intervention, on caregivers' knowledge, beliefs, and perceptions of short stature and adherence to its treatment. Patients and Methods: The evaluation of the TUITEK® patient support programme was conducted among 31 caregivers of children with short stature and receiving r-hGH treatment via the easypod™ auto-injector device in Taiwan. Caregivers within the 'high risk' category for knowledge, beliefs and perception factors influencing adherence to r-hGH treatment (disease and treatment coherence, emotional burden, self-administration, and treatment-related anxiety) were identified via the TUITEK® personalization questionnaire and followed up with bi-weekly telephone calls by a nurse practitioner over a 3-month period. A Wilcoxon signed-rank test was used to compare changes in questionnaire-based scoring patterns between baseline and follow-up. Results: Between baseline and follow-up, the percentage of caregivers scoring as 'high risk' for emotional burden reduced by 37%; there was an improvement in confidence of self-administration by 57% and the percentage of caregivers scoring as 'high risk' for treatment-related anxiety reduced by 52%. At follow-up, all caregivers classified as 'high risk' within the disease and treatment coherence item at baseline moved into the 'low risk' category. Statistically significant changes in questionnaire scores between baseline and follow-up for disease and treatment understanding, emotional burden, self-administration, and treatment-related anxiety were also observed. Conclusion: These findings indicate that the TUITEK® patient support programme can positively address disease and treatment-related barriers amongst caregivers regarding optimal adherence of their children to r-hGH treatment, which has the potential to positively impact on adherence levels and patient clinical health outcomes.

Implementation of a cauda equina service in a medium-sized district general hospital in the UK.

AIM: This project explored how the implementation of national guidance for investigation and management of patients with suspected cauda equina syndrome impacted on service provision. METHODS: Retrospective analysis of patients with suspected cauda equina syndrome during 12 months before the implementation of the national guidelines were compared with data from the 21 months following. RESULTS: Monthly mean numbers of referrals for suspected cauda equina syndrome increased from 10.1 to 18.9 (P<0.001). Statistically significant increases were also seen in the total number of magnetic resonance imaging scans for suspected cauda equina syndrome, and the number of magnetic resonance imaging scans performed out of hours. The mean time interval, from magnetic resonance imaging scan confirming cauda equina syndrome to starting emergency decompressive surgery, reduced from 14.87 hours to 9.57 hours. CONCLUSIONS: Compliance with the national guidance for suspected cauda equina syndrome is imperative for patients to receive optimal treatment. However, this project has demonstrated challenges related to increased pressure on resources.

Telephone Fracture Clinic Consultations: A Satisfactory Solution in Lockdown.

Introduction The COVID-19 pandemic was a catalyst to many learning opportunities within clinical practice in the UK. Attempts were made to reduce footfall within all institutions and within the study unit; this led to alterations in fracture clinic provision. An alternative method was developed whereby most of the initial contacts were in person and much of the follow-up was done remotely. The aim of this study was to evaluate patient satisfaction and views on this alteration in service. Methods The first 299 patients who had fracture clinic appointments delivered by telephone consultation at this institution during the pandemic in early 2020 were retrospectively identified and sent a postal survey. Satisfaction levels were assessed through a degree of agreement with statements (nine items), yes/no answers (four questions), and space for comments. Results One hundred and thirty-one survey responses were included (44% response rate). The majority of patients (82%) were satisfied overall with the care they received. Although 78% of patients stated that they preferred a telephone consultation to attend a face-to-face hospital appointment during the pandemic, only 22% stated they would have preferred this in normal (pre-COVID-19) times. Interestingly 62% of patients stated they would be happy for further fracture clinic appointments to be carried out in the same way. Discussion Most of the remote consultations were in follow-up rather than new patients. Patients were adaptable to this alternative method of care delivery. There could be a role for its integration into the options for fracture clinic delivery in the future.

What Potentially Modifiable Factors are Associated With Treatment Nonadherence in Pediatric Growth Hormone Deficiency? A Quantitative Study.

OBJECTIVE: A recent systematic review reported that up to 71% of patients with growth hormone deficiency and their families are nonadherent to treatment as prescribed. Nonadherence to growth hormone treatment presents a substantial and costly problem for the patient, health care provider, and health care system. The current study uniquely investigated the potentially modifiable factors associated with treatment nonadherence in this endocrine disorder. METHODS: The cross-sectional study was conducted among 82 parent/caregivers of children with growth hormone deficiency who were receiving growth hormone treatment. Self-report questionnaires investigated parent/caregiver perceptions and experiences of their child's condition and prescribed treatment, in addition to their perceived relationship with their health care professional. The 8-item Morisky medication adherence scale was used for the assessment of treatment adherence. RESULTS: Sixty-two percent of parents/caregivers were found to be nonadherent to growth hormone treatment as prescribed. Illness perceptions (consequences, identity, and coherence) and treatment concerns were found to be significantly associated with treatment adherence, as was the quality of the health care professional-parent/caregiver relationship. CONCLUSION: The study confirmed the extent of the adherence problem evident among the pediatric growth hormone deficiency population. In addition, it presented an insight into the explanatory factors that underpin nonadherence to growth hormone treatment. Our findings can be used to inform the development of adherence-focused interventions, with the purpose of supporting patients and their families and improving the use of prescribed growth hormone treatment within endocrine clinical practice.

Exploring Potentially Modifiable Factors That Influence Treatment Non-Adherence Amongst Pediatric Growth Hormone Deficiency: A Qualitative Study.

INTRODUCTION: A recent systematic review found that up to 71% of children with growth hormone deficiency and their families are non-adherent to treatment as prescribed. A key way to better understanding the complex issue of pediatric non-adherence is to explore the perceptions and experiences of the parent/caregiver. Our study is the first to look specifically at the potentially modifiable factors that influence non-adherence to rhGH treatment amongst parents/caregivers of children with this endocrine disorder. METHODS: Fourteen semi-structured telephone interviews were conducted to explore parents/caregivers' perceptions and experiences of their child's condition and prescribed treatment, in addition to their perceived relationship with their healthcare professional. The findings were thematically analyzed and narratively synthesized, in line with the qualitative approach of Braun and Clarke (2006). RESULTS: Potentially modifiable factors that influence non-adherence to growth hormone treatment were grouped under four themes: 1. Device Burdens, 2. Treatment Considerations, 3. Logistical Interferences and 4. Interpersonal Influences. CONCLUSION: Our exploratory study presents the wide range of potentially modifiable factors that influence the way in which growth hormone treatment is used. These findings can, in turn, be used to inform and promote the development of targeted, adherence-focused interventions, to support growth hormone deficient children and their families and optimize the use of prescribed growth hormone treatment within endocrine clinical practice.

Improving Mental Health Help-Seeking Behaviours for Male Students: A Framework for Developing a Complex Intervention.

Men are less likely to seek help for mental health difficulties and this process is often used to help explain the disproportionally higher suicide rates compared to women. Furthermore, university students are often regarded as a vulnerable population group with a lower propensity to seek help. Thus, male students are a very high-risk group that is even more reluctant to seek help for mental health difficulties, placing them at high risk of suicide. Often, student mental health problems are highlighted in the media, but very few evidence-based solutions specifically designed for male students exist. The current paper seeks to provide a comprehensive framework about how to better design mental health interventions that seek to improve male students' willingness to access psychological support. The Medical Research Council's (MRC's) framework for developing a complex intervention was used to develop an intervention relevant to male students. In this paper, previous help-seeking interventions and their evaluation methods are first described, secondly, a theoretical framework outlining the important factors male students face when accessing support, and thirdly, how these factors can be mapped onto a model of behaviour change to inform the development of an evidence-based intervention are discussed. Finally, an example intervention with specific functions and behaviour change techniques is provided to demonstrate how this framework can be implemented and evaluated. It is hoped that this framework can be used to help reduce the disparity between male and female students seeking mental health support.

Identifying Potentially Modifiable Factors Associated with Treatment Non-Adherence in Paediatric Growth Hormone Deficiency: A Systematic Review.

BACKGROUND: Despite the developments of recombinant growth hormone (rhGH) treatment and the benefits in long-term clinical health outcomes, evidence has shown that many children with growth hormone deficiency (GHD) still fail to achieve their target adult height. Suboptimal outcomes have been largely attributed to treatment non-adherence. METHODS: A search of 11 electronic databases was undertaken to identify relevant articles, published in English, between 1985 and 2018. Additional search strategies included hand-searching topic review articles to identify eligible studies. Articles were screened against the inclusion eligibility criteria and data on sample characteristics, study design, outcomes, and key findings was extracted. The results were narratively synthesised and categorised using the COM-B theoretical framework. RESULTS: Twenty-one full-text articles were assessed for eligibility, of which 6 articles met the inclusion criteria. The prevalence of non-adherence in the included studies varied from 7 to 71%. Potentially modifiable factors associated with rhGH non-adherence were categorised within the COM-B framework; key factors included: a lack of knowledge and understanding of the condition and treatment, discomfort and pain associated with injections, and the quality of the healthcare professional-patient relationship. CONCLUSION: This review highlights the scope of the adherence problem evident amongst the paediatric GHD population and in addition presents the wide range of potentially modifiable factors that explain this health-related behaviour.

The Intentional Non-Adherence Scale (INAS): Initial development and validation.

OBJECTIVE: Adherence continues to be a major challenge in healthcare but there is still limited understanding of all the factors which can influence adherence behaviour. The present study was designed to identify a range of factors associated with intentional non-adherence and to see if they could be formed into a psychometrically sound scale. METHODS: Patients in three different clinical groups (Hypertension (N = 175); Oncology (N = 115); Gout (N = 196)) were given the new scale together with an adherence self-report and/or biomarker measure. Other, more established measures of factors known to be associated with adherence (BMQ, PAM, BIPQ), were also completed by patients for comparative and validation purposes. Exploratory Factor Analysis (EFA) was conducted to examine the factor structure of the new scale, and other statistical analyses were used for testing the psychometric properties of the new scale. RESULTS: EFA revealed two factors, which were labelled "Resisting illness" and "Testing treatment". Both scales were found to have good psychometric properties and explained unique variance in adherence in all three clinical groups. CONCLUSION: This new scale shows promise in describing and explaining some relatively novel factors underlying treatment non-adherence. Further work in different patient groups and clinical contexts is needed to confirm the factor structure and predictive value of these scales.

Reducing returns to theatre for neck of femur fracture patients.

The Royal United Hospital, Bath, admits approximately 550 patients with neck of femur fractures per year. The risks from returning to theatre for this patient group are often life-threatening. Post-operative wound ooze was noted to cause a significant rate of return to theatre, with increased lengths of stay and patient morbidity. A wound closure protocol was agreed by the consultant body. This information was disseminated by email and teaching sessions to all members of the multidisciplinary team, including surgeons, theatre staff and ortho-geriatricians. The plan-do-study-act model for improvement was used to reduce rates of returns to theatre for wound ooze. Interventions included cyclical teaching during each trainee rotation, updated inductions, posters, email reminders and scrub team involvement to open the protocol sutures unprompted. The primary outcome measure was returns to theatre for wound complications. Baseline data showed 4 returns to theatre over a two month period (4.40% of patients). Length of stay for each patient affected by wound ooze was also compared to the departmental mean. In the 6 month intervention period there was one return to theatre (0.36% of patients). The observed reduction saved the department an estimated £13,831 in length of stay alone. The standardisation of wound closure protocol, with continued reinforcement to all members of the multidisciplinary team, improves patient outcome in this group. Mobilising a group of clinicians across a variety of specialities, with one common goal, is highly effective for patients, improves multidisciplinary working and reduces cost.

Chest drain care bundle: Improving documentation and safety.

Chest drain insertion is a common advanced procedure with a significant associated risk of pain, distress, and complications. Nationally, audit and recommendations from leading bodies have highlighted a number of safety concerns around chest drain insertion. Audit work has demonstrated poor levels of documentation; particularly around use of premedication, use of ultrasound guidance and consent. This has obvious potential consequences for patient safety and thus is an important target for improvement work. This project quantifies current standards of documentation and aims to improve this through a combination of accessible and easy to read guidelines, education, and the introduction of a chest drain insertion bundle. National best practice standards were identified through review of national guidance. Drain insertion was prospectively analysed over a three month period to establish baseline standards of documentation. This initial work was presented and a bundle and clinical guidelines produced. Chest drain insertion was then reaudited and assessed for improvement. Results demonstrated an improvement in many areas of documentation, pushing local results above the national average. However, only 40% of cases used the new bundle due to a mixture of staff rotation and an unexpectedly high proportion of drains inserted in non targeted areas including the emergency department, theatre, and intensive care. Despite this, the introduction of accessible guidance and bundle has significantly improved chest drain insertion documentation to the benefit of all.

Comparison of median frequency between traditional and functional sensor placements during activity monitoring.

Long-term monitoring is of great clinical relevance. Accelerometers are often used to provide information about activities of daily living. The median frequency (fm) of acceleration has recently been suggested as a powerful parameter for activity recognition. However, compliance issues arise when people need to integrate activity recognition sensors into their daily lives. More functional placements should provide higher levels of conformity, but may also affect the quality and generalizability of the signals. How fm changes as a result of a more functional sensor placement remains unclear. This study investigates the agreement in fm for a sensor placed on the back with one in the pocket across a range of daily activities. The translational and gravitational accelerations are also computed to determine if the accelerometer should be fused with additional sensors to improve agreement. Twelve subjects were tested over four tasks and only the "vertical" x-axis showed a moderate agreement (Intraclass Correlation Coefficient of 0.54) after correction for outliers. Generalizability across traditional and functional sensor locations might therefore be limited. Differentiation of the signal into a translational and gravitational component decreased the level of agreement further, suggesting that combined information streams are more robust to changing locations then singular data streams. Integrating multiple sensor modalities to obtain specific components is unlikely to improve agreement across sensor locations. More research is needed to explore measurement signals of more user friendly sensor configurations that will lead to a greater clinical acceptance of body worn sensor systems.