Future acceptance of automated insulin delivery systems in youths with type 1 diabetes: validation of the Italian artificial pancreas-acceptance measure.

AIM: The purpose of this study was to develop a questionnaire to examine the future acceptance of Automatic insulin delivery systems (AIDs), their perceived usefulness, ease of use, and trust in the device in subjects with type 1 diabetes (T1D). METHODS: A questionnaire in Italian, based on the Technology Acceptance Model, was developed to examine intention to use AIDs, considered as a measure of future acceptance, and its determinants to use the system. A total of 43 questions for children and 46 for parents were included, and a 5-point Likert scale was used. RESULTS: 239 subjects with T1D using multiple daily injections (MDI) or sensor-augmented pump (SAP) and their parents completed the questionnaire. The completion rate was excellent, with almost 100% of items answered. The overall Cronbach's coefficient for children and adolescents was 0.92 and 0.93 for parents, indicating excellent internal consistency in both groups. Parent-youth agreement was 0.699 (95% confidence interval: 0.689-0.709), indicating a good agreement between the two evaluations. Factor analysis identified measurement factors for the "artificial pancreas (AP)-acceptance labeled benefits and hassles of AIDs, and the internal consistency of the total scale was alpha = 0.94 for subjects with T1D and 0.95 for parents. The level of AP acceptance was more than neutral: 3.91 ± 0.47 and 3.99 ± 0.43 (p = 0.07) for youths and parents, respectively (possible score range 1 to 5, neutral score is 3.0). Parents reported higher scores in the benefit items than children-adolescents (p = 0.04). CONCLUSIONS: We developed a new questionnaire based on the items available in the literature, and we demonstrated that the "AP-acceptance" reveals a meaningful factor structure, good internal reliability, and agreement between parent-young people evaluations. This measure could be a valuable resource for clinicians and researchers to assess AP acceptance in pediatric patients with T1D and their parents. This patient profiling approach could help to enroll candidates for AIDs with proper expectations and who most likely will benefit from the system.

Examining Coping Strategies and Their Relation with Anxiety: Implications for Children Diagnosed with Cancer or Type 1 Diabetes and Their Caregivers.

The onset of chronic diseases in childhood represents a stressful event for both young patients and their caregivers. In this context, coping strategies play a fundamental role in dealing with illness-related challenges. Although numerous studies have explored coping strategies employed by parents of children with chronic diseases, there remains a gap in the understanding of children's coping strategies and their correlation with their and their parents' anxiety. This study aims to investigate coping strategies and their interaction with anxiety in groups of young patients with cancer, type 1 diabetes (T1D), and their respective caregivers, in comparison to healthy children and caregivers. We recruited a total of 61 control children, 33 with cancer, and 56 with T1D, 7 to 15 years old, along with their mothers. Each participant completed a customized survey and standardized questionnaires. No significant differences emerged in coping strategies used by children among the different groups. However, when examining the association between coping strategy and anxiety, we found specific patterns of interaction between children's use of coping strategies and their and their mothers' anxiety levels. This study underscores the importance of an illness-specific approach to gain deeper insights into this topic and develop targeted interventions aimed at enhancing the psychological well-being of these vulnerable populations.

Sleep and psychological characteristics of children with cancers and type 1 diabetes and their caregivers.

OBJECTIVES: Children with chronic illnesses and their parents are more at risk to develop sleep problems, which are linked to worse psychological and physical well-being. This study aimed to assess sleep patterns and their connections with psychological outcomes in children with type 1 diabetes (T1D) and cancer and their caregivers, compared to a control sample. In addition, we explored the associations between caregiver and child's sleep quality across the three groups. METHODS: We enrolled 56 children with T1D, 33 children with cancer, and 61 healthy children between 7 and 15, and their respective caregivers. Caregivers filled out an ad-hoc survey assessing their sleep disturbances, parenting stress, general well-being, anxiety, and their children's sleep patterns and psychological adjustments. RESULTS: Children with cancer showed lower sleep quality than the other groups. Moreover, worse psychological adjustment was associated with greater sleep disturbances in both clinical groups. As for caregivers, the cancer group reported the worst sleep quality and greater anxiety compared to the other samples. Greater anxiety was also linked to worse sleep quality. Furthermore, greater sleep problems in children were associated with poorer caregivers' sleep quality in the whole sample and the T1D group. CONCLUSIONS: A better understanding of sleep patterns and problems for chronically ill children and their parents is fundamental to provide adequate care for these vulnerable populations. Furthermore, an illness-specific approach may better inform and guide the practitioners in clinical practice.

Spending Time with Mothers as a Resource for Children with Chronic Diseases: A Comparison of Asthma, Type 1 Diabetes, and Cancer during COVID-19 Pandemic.

Due to the COVID-19 pandemic, many families had to manage new difficulties, especially those of chronically ill children. More and more research has focused on the negative effects of the pandemic on psychological wellbeing, while less is known about the resources. The present study aimed to explore the role of time spent with mothers in chronically ill children's populations during the COVID-19 pandemic. Moreover, it explored the differences in mothers' and children's psychosocial functioning in three clinical populations. Four groups were recruited and compared: 7-15 year old children with asthma (45), type 1 diabetes (52), and cancer (33), as well as their healthy counterparts (41), and their respective mothers. They were administered standardized questionnaires and ad hoc surveys assessing psychological wellbeing and worries. Children of the four groups scored significantly differently with respect to the concerns for contagion, internalizing symptoms, and prosocial behaviors; mothers had worries about the consequences of their children's contagion related to the chronic illness, as well as time with the child. The multiple linear regression model showed an association of being affected by cancer, suffering from type 1 diabetes, and spending less time with the child with an increase in children's internalizing problems. Time with mothers seemed to be a resource for psychological wellbeing during the pandemic. Clinical implications are discussed.

Growing up with type 1 diabetes mellitus: Data from the Verona Diabetes Transition Project.

AIM: Transition from paediatric to adult care is a critical step in life of emerging adults with type 1 diabetes. We assessed, according to indicators established by panel of experts, clinical, socio-demographic and psychosocial factors in young adults with type 1 diabetes throughout structured transition to investigate the associations, if any, with HbA1c value at time of transition. METHODS: The "Verona Diabetes Transition Project" started in January 2009: a structured transition program, shared between paediatric and adult clinic, was organised with a multi-disciplinary team. All young adults underwent a semi-structured interview by a psychologist, before transition. Minimum age for transition was 18 years. RESULTS: 222 (M/F = 113/109) young adults moved to adult care from January 2009 to March 2020. The mean time between the last paediatric visit and the first adult visit ranged from 13.6 ± 6.1 months at the beginning of the project to 3.6 ± 11.5 months over the following years. At first adult clinic attendance, women showed higher HbA1c values (70 ± 11 mmol/mol vs. 65 ± 7 mmol/mol or 8.57% ± 1.51% vs. 8.14% ± 0.98%, p = 0.01), higher frequency of disorders of eating behaviours (15.6% vs. 0%, p < 0.001) and poor diabetes acceptance (23.9% vs. 9.7%, p < 0.001) than men. Mediation analyses showed a significant mediating role of glucose control 2 years before transition in the relationship between poor diabetes acceptance and glucose control at transition. CONCLUSIONS: This study demonstrated a delay reduction in establishing care with an adult provider and suggested the potential role of low diabetes acceptance on glycemic control at transition. Further studies are needed to confirm and expand these data.

Short-Term Effects of COVID-19 Lockdown in Italian Children and Adolescents with Type 1 Diabetes Mellitus: The Role of Separation Anxiety.

In March 2020, the Italian Government imposed mandatory home confinement to limit the spread of COVID-19. Few studies assessed the psychophysical impact of COVID-19 on chronically ill children. This study examined these effects on children with Type 1 Diabetes Mellitus (T1D) and their caregivers. Seventy-one patients (7-13 years) with T1D and their caregivers were administered a survey created ad hoc and some standardized questionnaires, assessing psychological well-being and anxiety. Medical data (physical and biochemical characteristics) were recorded before (T0, January-February) and after (T1, May-June) the lockdown. Paired Student t-test, Spearman two-tailed correlations, and a linear regression model were used for statistical analysis. Children at T1 showed higher BMI (body mass index), daily total and basal insulin dose, and time spent in therapeutic range, and they showed lower HbA1c (glycated hemoglobin), time spent above the therapeutic range, and standard deviations of the mean glucose values than at T0. A total of 32.9% scored in the clinical range for separation anxiety. The increase in separation anxiety was predicted by younger age, female gender, more recent T1D diagnosis, less time spent in therapeutic range at T1, and higher perceived fear of COVID-19 infection. In a pandemic context, separation anxiety may be stronger in younger females, with more recent T1D diagnosis and poor metabolic control, thus affecting the parent's ability to manage diabetes and to support children's autonomy.

Mothers and Fathers Parenting Stress and Their Perception of Children's Psychosocial Functioning in Paediatric Diabetes: A Pilot Study.

(1) Background: In the context of a child with Type 1 Diabetes Mellitus (T1DM), the rearrangement of the family's lifestyle can account for an increased risk of experiencing psychosocial problems for both child and parents. Those few studies on pediatric diabetes, which focused on parents' perception of children's psychological strengths and weaknesses, reported significantly higher rates of children's emotional and conduct problems associated with an imbalance in the Hemoglobin A1c (HbA1c). The main aim of this paper was to assess the role of parental perception of children's psychosocial symptoms as a mediator of the perceived parenting stress, considering mother and father separately. (2) Methods: The study involved 12 parent couples (Mothers Mage = 40.25, SD = 6.58; Fathers Mage = 42.5, SD = 6.38) of children with T1DM aged between 7 and 11 years (Mage = 8.8, SD = 0.996). Parents completed questionnaires such as the Strengths and Difficulties Questionnaire for parents and their perspective of their child, and the Parenting Stress Index-Short Form. (3) Results: Mothers and fathers had significant differences in the perception of their child's internalizing symptoms. Specifically, mothers present a greater perception of the mentioned symptoms compared to fathers. Mediation models showed that only for fathers' perception of the child conduct problems has a significant role between the fathers' perception of dysfunctional interaction with the child and the HbA1c. (4) Conclusions: The current study provides useful evidence also for clinical settings, suggesting that an interesting interplay between parenting stress, perception of children's symptoms and glucometabolic control should be taken into consideration.

The ALBA project: an evaluation of needs, management, fears of Italian young patients with type 1 diabetes in a school setting and an evaluation of parents' and teachers' perceptions.

OBJECTIVE: To determine how Italian parents and school personnel of 6-13-year-old children with type 1 diabetes (T1D) manage during school hours, including insulin administration, management of hypoglycemia, and glucagon use. A further aim was an investigation into the responsibilities and training of school personnel regarding diabetes. RESEARCH DESIGN AND METHODS: After an initial qualitative phase, semi-structured questionnaires were completed by a sample of parents and teachers. RESULTS: 220 parent and 52 teacher questionnaires were completed. 43.6% of parents said diabetes had negatively influenced school activities. Children either self-administer insulin, or have help from a parent, since there is very rarely a nurse present (3.6%) or a teacher who will take responsibility for the treatment (2.9%). Most parents (55.9%) stated either that the school had no refrigerator to store glucagon or that they did not know if the school was so equipped. A small percentage of teachers considered their schools to be equipped to manage an emergency (23%) and said they would use glucagon directly in an emergency (14.9%). Only 40.4% of teachers said that they had received any specific training. CONCLUSIONS: The study shows that people who are not directly involved have superficial knowledge of the different aspects of diabetes, even though no parents reported episodes of neglect/incorrect management. There is no legislation which clearly defines the role of the school in the care of children with T1D, and teachers are not trained to help them. Training sessions for school personnel and greater legislative clarity about the 'insulin and glucagon question' are key factors that may improve the full integration of the child with diabetes.

Knowledges about herbal products among subjects on warfarin therapy and patient-physician relationship: a pilot study.

PURPOSE: The purpose of our study was to analyse behaviours and patient-physician relationship about phytotherapy among a sample of Italian patients on warfarin therapy for atrial fibrillation. METHODS: During a 4-month study period, interviews of patients on warfarin therapy, followed regularly in the medical laboratories to monitor INR values, were conducted on the basis of a pre-structured 25-item questionnaire. RESULTS: Among a study population of 294 patients, 69 subjects reported to have been taking one or more phytotherapic products in the last year in combination with warfarin. Users were mostly in the age group >50 years and had a low level of education. Five out of 69 patients reported side effects, while 16/69 referred an unstable INR value. The majority of our subjects considered phytotherapy useful and without risks. CONCLUSIONS: The present survey highlights the potential risk of confidence with the 'natural world', the lack of discussion on this argument among health care providers and patients on warfarin therapy and the need to monitor strictly the INR value.

Safety implications regarding use of phytomedicines.

OBJECTIVE: Since the approach of the general population to phytomedicine is that the therapy therapy is natural and therefore safe, the aim of this study was to investigate the relationship between the use of herbal compounds, alone or in combination with traditional drugs, and the appearance of side-effects among a sample of Italian women. METHODS: Our research was conducted over a 5-month period in the outpatient ambulatories of an urban university general hospital. The sample population consisted of women who were interviewed about phytotherapy use on the basis of a pre-structured questionnaire. RESULTS: Among 1,063 women contacted, 1,044 completed the interview and 491 (47%) reported taking at least one herbal compound in the last year; 272 women (55.4%) consumed only phytomedicines, while 219 (44.6%) also took traditional drugs. Seventy-three different herbal products were used, 32 were consumed in association with traditional drugs. Forty-seven of 491 (9.6%) women reported side-effects, 22 after taking only phytomedicines (8.1%), 25 in combination with traditional drugs (11.4%). The observed adverse manifestations included the following: gastrointestinal after dandelion, propolis or fennel; cardiovascular after liquorice, ginseng, and green tea; dermatological after propolis, thyme, arnica, and passionflower; and neurological after guarana and liquorice. Drugs taken in association and potentially involved in adverse reactions were NSAIDs, antibiotics, benzodiazepines, antihypertensives and oral contraceptives. In some cases (n=5), side-effects were so serious to justify an admission to the hospital. In 29/47 of cases (61.7%), the adverse reaction was not communicated to the doctor. CONCLUSIONS: Our data confirm that herbal products are largely taken on a self-treatment basis, and users have the conviction that these therapies are natural and therefore safe.

Herbal products: behaviors and beliefs among Italian women.

PURPOSE: The use of phytotherapy is growing worldwide, but the popular perception is that this kind of approach is natural and therefore safer than traditional medicine; for this reason the use is frequently not communicated to the doctor. Instead, even if many herbal remedies are benign in nature, some of these therapies have potentially harmful side effects or adverse interactions with other medications. So, the purpose of our study was to analyze the behavior patterns and decision-making modalities about herbal remedy use among a sample of Italian women. METHODS: During a 5-month period, interviews to women attending the outpatient ambulatory of an urban university general hospital were made on the basis of a pre-structured 25-item questionnaire. RESULTS: Among a random study population of 1,044 subsequent patients, 491 women (47.03%) reported to have been taking one or more herbal products in the last year, sometimes used during pregnancy or given to their children (35.23%). The 10 most frequently used herbal products reported were propolis, aloe, valerian root, blueberry, fennel, dandelion, mallow, arnica, thyme, and Echinacea. The major purposes for using these products were to stimulate the immune system and to cure respiratory problems. 47/491 (9.57%) women reported side effects, but only 36% referred to the doctor. In most of the cases, herbal products were taken in combination with drugs (44.61%) or homeopathic treatments (11.81%). The majority of our women did not obtain information about this kind of therapy from a health care provider (72.71%). CONCLUSIONS: The present survey highlights the general use of phytomedicines by a sample of Italian women, the potential risk of their confidence with the 'natural world,' and the lack of discussion on this argument with doctors and pharmacists. This suggests the importance of training for health care providers and the need of informational programs for consumers.

[Patologie delle alte vie respiratorie del bambino in ambulatorio: un'esperienza italiana. Diseases of the upper respiratory tract in children in ambulatory care: an Italian experience].

BACKGROUND: Overuse of antibiotics for children is widespread and contributes to the emergence of antibiotic-resistant bacteria. Moreover, non steroidal antiinflammatory drugs (NSAIDs) are often overprescribed despite of their renal and gastrointestinal side-effects. OBJECTIVES: To assess the behaviour and the factors influencing the prescribing practice of family pediatricians for the common upper respiratory diseases of pre-school children in an outpatient setting. METHODS: 125 family pediatricians, who provide primary care in an outpatient setting to young children in North-East of Italy (Veneto region), adhered to a survey consisting in a 40-item questionnaire about the factors that could influence their prescribing practice as regards otitis media (OM), pharyngitis (FGT) and broncopneumoniae (BPN) treatment of patients aged 0 to 5 years. Data were collected in November 2002. Descriptive analysis of data was performed using DELPHI TM7 professional Study Program. RESULTS: The child's age resulted an important factor, influencing the antibiotic prescription either in OM or in BPN. 86% of pediatricians emphasized the use of antipneumococcal vaccine, overall in children younger than 2 years with recurrent OM, while 71% adviced this vaccination in children younger than 5 years with relapsing BPN. The awareness of complications in OM and BPN often induced pediatricians to prescribe drugs. The most frequently prescribed antibiotic in OM, FGT and also BPN was amoxicillin for 7-10 days. According to the international guidelines, a small percentage (14%) of clinicians prescribe antibiotics for 5 days in OM, but most of them generally wait some hours to prescribe antibiotics. PenV was considered the most active drug in FGT and its disappearance from the market was considered negatively by italian pediatricians. Moreover, even if the rapid immunoenzymatic test for Group A beta-hemolyticus Streptococcus (GABHS) is considered sensitive, many pediatricians defined the throat culture the most accurate test to diagnose a GABHS pharyngitis. Paracetamol was frequently prescribed in these diseases, between 74% for OM and 53% for BPN. Among NSAIDs, niflumic acid and ibuprofen were the drugs most frequently prescribed in FGT and in OM respectively. About 30% of pediatricians refers that parents require drugs in the treatment of upper respiratory tract diseases. CONCLUSIONS: Our results show that antibotics are generally not over-prescribed by italian pediatricians, but often prescribed for a long time, likely because of fear of complications and uncertainty of the diagnosis, particularly in OM, being not always available the pneumotoscope. About NSAIDs, niflumic acid is frequently not evidence-based used in Italy. Frequently, side-effects associated with NSAIDs administration were reported.

Patterns and perceptions of complementary/alternative medicine among paediatricians and patients' mothers: a review of the literature.

UNLABELLED: For many families and their children, the use of complementary/alternative medicine (CAM) is an accepted adjunct or alternative to conventional therapy, even if data available in the literature regarding risks and adverse drug reactions (ADRs) pertaining to childhood populations are scarce. Moreover, despite widespread and increasing use of CAM, there are limited data on how paediatricians communicate with mothers and/or patients about CAM. Therefore, we report the studies available in the literature in the paediatric field and summarise what is known about ADRs and risks of CAM, taking into account in particular problems related to interactions between phytotherapy and conventional medicines and to counselling. CONCLUSION: from the analysis of the literature, some interesting aspects emerge: (1) the extent of CAM use in the paediatric field is increasingly sought by parents of children with chronic illnesses; (2) most parents who choose CAM medicine for their children believe that these therapies are "natural" and thus "safe" and (3) physicians often feel to know too little about CAM and wish to learn more for different reasons including "to dissuade whether the alternative method is unsafe and/or ineffective". Therefore, paediatricians should be prepared to discuss alternative therapies with parents, since talking about CAM may help to minimise the risks and to restrain parental misconceptions and doubts. Educational interventions for parents should also be performed to bring about a more aware use of traditional and alternative medicines.