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Aim The metabolic and psychological management of paediatric type 1 diabetes mellitus (T1DM) can be challenging over time given that T1DM may cause a negative emotional burden and, consequently, result in poor metabolic control of the disease. The objectives of this study are to translate the Problem Area in Diabetes Survey–Pediatric version (PAID‐Peds) into Spanish, adapt it culturally and validate it. Design Multicenter cross sectional study. Methods 636 patients aged 8–17 years, diagnosed with T1DM, under treatment with insulin and follow‐up at the Miguel Servet University Hospital in Zaragoza (Aragón, Spain), the Ramón y Cajal University Clinical Hospital in Madrid (Spain) and at the Sant Joan de Déu Hospital in Barcelona (Catalonia, Spain) between 1 January 2023 and 31 December 2024 will be included. This study will consist of two phases: (1) Translation and cultural adaptation of the original PAID‐Peds® survey into Spanish following eight steps; (2) Validation of the Spanish version of the PAIS‐Peds® survey. The statistical analysis will be performed using Jamovi® 2.1.23. The reliability or internal consistency will be calculated using Cronbach's alpha index (considering an index higher than 0.8 to be good) and the test–retest will be evaluated using the intraclass correlation coefficient. For validity, confirmatory factor analysis will be calculated. This study has been approved by the ethics and research committees at each centre. Results The translation and validation into Spanish language of the Problem Area in Diabetes Survey‐Pediatric version will be feasible, valid and reliable to detecting the youth‐perceived burden of T1DM. Therapeutic education in diabetes—recommended by the WHO and the Diabetes Education Study Group—has shown encouraging results in glycaemia and psychosocial and behavioural factors in T1DM.

Health related quality of life (HRQoL) is a relevant result when assessing the course of different pathologies and the efficacy of their treatments. HRQoL has been studied previously on adults born small for gestational age (SGA), both in the general population and in patients who had received recombinant human growth hormone (rhGH) treatment, with disparate results. Our study included 50 adults who had received rhGH treatment for the SGA indication in 4 Spanish hospitals. Data have been gathered retrospectively from their clinical records, current weight and height were measured, and patients have been asked to fill out SF-36 and QoLAGHDA quality of life forms, and the Graffar test to evaluate their socio-economical status. Patient’s adult height was – 1.2 ± 0.9 SD, lower than their target height of 1 ± 0.8 SD, but gaining 1.7 ± 1 SD from the beginning of the treatment. SF-36 test results showed lower scoring on Mental Health domains than on those related to Physical Health. No correlation was found between HRQoL results and final height, rhGH treatment duration or puberty. Correlation was indeed found between QoLAGHDA and several domains of SF-36, but QoLAGHDA detected fewer patients with low HRQoL than SF-36. Thus, it is concluded that SGA patient’s follow-up should include a HRQoL, neuro-cognitive and psychiatric assessment in their transition to adult age. Adult SGA patients without catch up growth have impaired HRQoL, especially in mental health domains.

Background Caregivers of children undergoing growth hormone treatment often face stress and stigma. In this regard, family-centered approaches are increasingly considered, wherein caregivers’ mental wellbeing is taken into account to optimize children’s health-related outcomes and behaviors (e.g., treatment adherence). Here, mindfulness and parenting-based programs have been developed to support the mental wellbeing of caregivers and, in turn, promote richer interactions with the children. Nevertheless, this type of program can face drawbacks, such as the scheduling and availability of family members. Recent digital health (DH) solutions (e.g., mobile apps) are showing promising advantages as self-management support tools for improving wellbeing and behaviors related to the treatments. Although, further evidence is necessary in the field of Growth Hormone Treatment (GHt). Accordingly, this study aims to examine the usability of a mobile DH solution and the feasibility of a DH intervention designed to promote emotional and mental wellbeing of caregivers of children undergoing GHt. Methods This is a prospective mixed-methods (qualitative-quantitative) exploratory study composed of two sub-studies, including caregivers of children undergoing GHt. Sub-study one (SS1; n = 10) focuses on the usability of the DH solution (detecting potential barriers and facilitators) and an ad hoc semi-structured interview will be administered to the caregivers after using the DH solution for one month. Sub-study two (SS2; n = 55) aims to evaluate the feasibility of the DH intervention on caregivers’ perceived distress, positive affectivity, mental wellbeing, self-efficacy, together with the children’s quality of life and treatment adherence. All these parameters will be assessed via quantitative methods before and after 3-months of the DH intervention. Usability and engagement will also be assessed during and at the end of the study. Results It is expected that significant amounts of data will be captured with regards of the feasibility of the DH solution. Discussion The manuscript provides a complete protocol for a study that will include qualitative and quantitative information about, on one hand, the user-friendliness of the DH solution, and on the other, the effects on caregivers’ emotional, as well as, behavioral parameters in terms of the usability and engagement to the DH solution. The findings will contribute to the evidence planning process for the future adoption of digital health solutions for caregiver support and better health-related outcomes. Trial registration ClinicalTrials.gov, ID: NCT04812665.

Background Metabolic control and psychological management of paediatric type 1 diabetes mellitus (T1DM) can be challenging over time. Development of an instrument to assess the youth-reported burden could aid in preventing T1DM-associated diseases. Methods The aim of this study was to translate and validate the Spanish version of the Problem Area in Diabetes Survey–Pediatric version (PAID-Peds). A multicentre, cross-sectional translation and linguistic validation study was performed on a sample of 30 participants aged 8–17 years with a minimum 1-year history of T1DM diagnosed at the Miguel Servet University Hospital in Zaragoza (Aragon, Spain), Ramón y Cajal University Clinical Hospital in Madrid (Spain), and Sant Joan de Déu Hospital in Barcelona (Catalonia, Spain). The qualitative validation consisted of translation into Spanish and back-translation into English of the Paid-Peds survey and subsequent administration to the sample population. Data were gathered on parameters related to sociodemographic characteristics and metabolic control. Validity, feasibility, and test-retest reliability were evaluated. Internal consistency was determined using Cronbach’s alpha coefficient, test-retest reliability by means of interclass correlation, and paired samples using the Wilcoxon W-test. The study was approved by the ethics and research committees at each participating centre. Results The study assessed 30 children (46.7% female) with an average age of 13.33 ± 2.98 years; mean age at onset was 5.70 ± 3.62 years, and the mean disease duration was 7.63 ± 4.36 years. The mean score on the PAID-Peds survey was 42.88 ± 17.85. Cronbach’s alpha coefficient was 0.90. Test-retest reliability measured by interclass correlation coefficient was 0.8 (95% CI: 0.63–0.90). No significant differences in total scores were found between test and retest (Wilcoxon W-test: 289; p = 0.051). Conclusions The Spanish version of the PAID-Peds survey is a feasible, valid, and reliable instrument to assess the youth-perceived burden of T1DM.

Caregivers of children living with type 1 diabetes (T1D) face multiple challenges that significantly impact their mental health and quality of life. The well-being of caregivers directly affects the management of the child's condition. The Adhera Caring Digital Program (ACDP) is a comprehensive, digitally delivered program, designed to support family caregivers in enhancing self-management and well-being. This study aims to assess how the ACDP influences caregivers' mood, emotional well-being, and health-related quality of life within the context of T1D. This study aimed to evaluate the impact of ACDP on caregivers' psychological well-being and caregiving outcomes. This was a two-step, prospective, mixed methods study targeting caregivers of children living with T1D who were under the care of a pediatric endocrinologist at Miguel Servet Children's University Hospital in Zaragoza, Spain. In substudy 1 (SS1), qualitative and quantitative data were collected to optimize the ACDP. In substudy 2 (SS2), caregivers used the optimized ACDP for three months. Psychometric assessments were conducted at baseline and follow-up to evaluate positive mood states, general well-being, self-efficacy, and lifestyle behaviors. This paper focuses on SS2. Ninety caregivers participated in SS2. Positive affect significantly increased (P<.001), and negative affect decreased (P<.001) on the Positive and Negative Affect Schedule (PANAS). Depression, anxiety, and stress scores were reduced (P<.001) on the Depression, Anxiety and Stress Scale-21 Items (DASS-21). General well-being, measured by the Mental Health Continuum-Short Form (MHC-SF) and self-efficacy, assessed using General Self-Efficacy Scale (GSE), improved significantly (P<.001). Health-related quality of life (HrQoL) scores and Mediterranean Diet Quality Index scores increased modestly (P=.03, and P=.04, respectively). The ACDP intervention improved caregivers' psychological well-being and self-efficacy. These findings highlight the potential of digital solutions to support caregiver mental health and positively influence diabetes management. Future research should explore long-term outcomes and scalability.

Managing a child undergoing growth hormone treatment (GHt) can be burdensome for the families, which can lead to psychological problems and poor treatment adherence. The Adhera Caring Digital Program (ACDP) is a mobile-based digital health intervention designed to support the physical and mental well-being of families of individuals with chronic conditions. This study aimed to evaluate the clinical feasibility of a digital intervention to support families by focusing on caregivers of children undergoing GHt and its impact on treatment adherence. This is a prospective observational study. A total of 51 caregivers of children undergoing GHt with low adherence (below 85%) to treatment were recruited at the Pediatric Endocrinology Unit at the Miguel Servet Children's University Hospital and enrolled into the ACDP for 3 months. A total of 51 parents participated in the digital intervention for 3 months. The use of ACDP was associated with a significant increase in adherence rate (P<.001). At baseline, all families had suboptimal adherence (below 85%), and after the intervention, 75% (n=38) of the families reached optimal levels of adherence. Also, the perceived pain of injection was reduced, as well as anxiety and stress. Initially, 21.56% (n=11) of caregivers reported depression symptoms, categorized as mild (11.76%, n=6), moderate (7.84%, n=4), and extremely severe (1.96%, n=1), while post intervention, only 1.96% (n=1) of caregivers reported depression as \"severe.\" Anxiety levels at baseline were reported by a total of 23.53% (n=12) of caregivers (mild: 7.84%, n=4, moderate: 13.73%, n=7, and severe: 1.96%, n=1). After the intervention, only 11.76% (n=6) reported mild (5.88%, n=3) or moderate (5.88%, n=3) anxiety levels. Initially, 23.5% (n=12) of caregivers reported stress as mild (7.84%, n=4), moderate (13.72%, n=7), and severe (1.96%, n=1) stress, and following the intervention, these symptoms reduced to 7.84% (n=4) (mild: 5.88%, n=3, severe: 1.96%, n=1). The ACDP is a promising tool, and it has been demonstrated to significantly increase the adherence rate, adding value to the patient and caregiver journey, and improving the management of growth hormone deficiency while promoting the overall well-being of family caregivers. Our results show that the digital support provided by the solution significantly increased the quality of life of the caregivers by increasing their psychological, emotional, and social well-being and decreasing their depression, anxiety, and stress symptoms.

[This corrects the article DOI: 10.2196/55023.].

A large language model (LLM) is a machine learning model inferred from text data that captures subtle patterns of language use in context. Modern LLMs are based on neural network architectures that incorporate transformer methods. They allow the model to relate words together through attention to multiple words in a text sequence. LLMs have been shown to be highly effective for a range of tasks in natural language processing (NLP), including classification and information extraction tasks and generative applications. The aim of this adapted Delphi study was to collect researchers' opinions on how LLMs might influence health care and on the strengths, weaknesses, opportunities, and threats of LLM use in health care. We invited researchers in the fields of health informatics, nursing informatics, and medical NLP to share their opinions on LLM use in health care. We started the first round with open questions based on our strengths, weaknesses, opportunities, and threats framework. In the second and third round, the participants scored these items. The first, second, and third rounds had 28, 23, and 21 participants, respectively. Almost all participants (26/28, 93% in round 1 and 20/21, 95% in round 3) were affiliated with academic institutions. Agreement was reached on 103 items related to use cases, benefits, risks, reliability, adoption aspects, and the future of LLMs in health care. Participants offered several use cases, including supporting clinical tasks, documentation tasks, and medical research and education, and agreed that LLM-based systems will act as health assistants for patient education. The agreed-upon benefits included increased efficiency in data handling and extraction, improved automation of processes, improved quality of health care services and overall health outcomes, provision of personalized care, accelerated diagnosis and treatment processes, and improved interaction between patients and health care professionals. In total, 5 risks to health care in general were identified: cybersecurity breaches, the potential for patient misinformation, ethical concerns, the likelihood of biased decision-making, and the risk associated with inaccurate communication. Overconfidence in LLM-based systems was recognized as a risk to the medical profession. The 6 agreed-upon privacy risks included the use of unregulated cloud services that compromise data security, exposure of sensitive patient data, breaches of confidentiality, fraudulent use of information, vulnerabilities in data storage and communication, and inappropriate access or use of patient data. Future research related to LLMs should not only focus on testing their possibilities for NLP-related tasks but also consider the workflows the models could contribute to and the requirements regarding quality, integration, and regulations needed for successful implementation in practice.

Background: Type 1 diabetes mellitus (T1DM) in pediatric patients often leads to emotional distress, impacting self-management. The PAID-Peds survey measures diabetes-related emotional burden but lacks a validated Spanish version. This study aimed to validate the Spanish PAID-Peds survey in children and adolescents with T1DM and correlate it with diabetic metabolic control parameters. Methods: A cross-sectional study was conducted from October 2022 to December 2023, recruiting 636 patients aged 8–17 years from three Spanish hospitals. Psychometric properties were assessed using Cronbach’s alpha for reliability and confirmatory factor analysis for construct validity. Associations between PAID-Peds scores and clinical measures, such as HbA1c, were examined. Results: The final sample consisted of 538 participants (84.59% response rate). The PAID-Peds survey showed high internal consistency (Cronbach’s alpha = 0.90). The confirmatory factor analysis indicated a satisfactory model fit (χ2 = 812.28, p < 0.001; RMSEA = 0.08). Weak correlations were found between PAID-Peds scores and HbA1c (r = 0.14, p < 0.001). Conclusions: The Spanish PAID-Peds survey is a reliable tool for assessing emotional burden in pediatric T1DM patients. Integrating it into clinical practice may improve early identification of emotional distress, aiding in better diabetes management. Further research should explore its application over time and in intervention studies.

Abstract Disclosure: A. De Arriba Munoz: None. A. García Durán: None. P. Sanz Aznar: None. S. Quer Palomas: None. I. Bilionis: None. A. Xifra-Porxas: None. J. Nuñez: None. R.C. Berrios: None. L. Fernández Luque: This investigator-sponsored study has been funded by Merck Healthcare KGaA, Darmstadt Germany, which is a type of sponsored independent research. As independent study, the funder does not participate, Adhera Health owns the solution used in the study (This applies to all authors from Adhera Health). Introduction: Growth hormone deficiency (GHD) affects both children and their caregivers, posing emotional, physical, and social challenges. This study examines the association between caregiver and child well-being. Methods: Fifty caregivers (mean age 42.1y; 31% male) of children with GHD (mean age 8.4y; 49% male) completed a 3-month digital program aimed at supporting their well-being.[IB1] In this study, we focused on the psychometric questionnaires completed by the caregivers. Associations between caregiver and child well-being were analyzed using Spearman’s correlation. Results: Children with better overall well-being (measured via KIDSCREEN-10) had caregivers with improved overall well-being (measured via PANAS, MHC-SF, GSE and DASS21). Specifically, items addressing the emotional and physical state of the children were among those strongly associated with caregiver well-being. For instance, children feeling sadder had parents feeling more stress (r=0.476, p<0.001) and anxiety (r=-0.471, p<0.001), while caregivers’ negative affect was higher when they felt their children were being treated unfairly (r=-0.583, p<0.001). Furthermore, only two QoLISSY child subscales were significantly associated with caregiver well-being: the child’s coping with the disease (Coping subscale) and their feelings about the treatment (Treatment subscale). For example, children coping poorly with the disease had parents who exhibited depressive symptoms (r=-0.486, p<0.001). Moreover, lower scores in the QoLISSY parent subscale “Effects on parents”, indicating parents who struggle with the management of the disease, were significantly associated with children feeling sadder (r=-0.340, p=0.009) and overall with poorer health (r=0.337, p=0.010). Finally, higher scores on the QoLISSY parent subscale “Future” were significantly associated with higher scores in the QoLISSY child subscale about their emotional well-being (r=0.509, p<0.001), indicating that less concern about the future was tied to better child emotional well-being. Discussion: This study underscores the strong relationship between child and caregiver well-being in families managing GHD. Children’s emotional and physical challenges are closely linked with caregiver mental health, as well as children’s coping and treatment experiences. These findings emphasize the need for family-centered interventions to support both children and caregivers, improving outcomes for families managing GHD. Presentation: Saturday, July 12, 2025