Parental practices that influence children's development: how often are they implemented and by whom-results from the NASCITA birth cohort study.

This study aims to assess how commonly 15 parental practices, known to have positive effects on child and adult health, are carried out by families in Italy, if they are related, and which characteristics are associated with implementation. Children participating in the NASCITA Cohort, a prospective study in which family pediatricians in Italy collect data on children and their families, were included if they had sufficient data. Data on practice implementation, socio-demographic characteristics, and interrelatedness between practices were analyzed. In all, 3337 children were included. Their mothers had an average age at birth of 33 years (range 17-52) and medium-high levels of education (86% of mothers) and employment (72%). No smoking or alcohol in pregnancy, supine infant sleeping position, and tummy time were the most commonly implemented practices (by over 85% of mothers, each), while the least common was exclusive breastfeeding at 6 months (28%). Parental practices are related and several socio-demographic characteristics influence their implementation, with mother's educational level and geographic area of residence influencing most of the practices (each influencing 12 of 15 practices). Low educational level (OR 0.34; 95% CI 0.26-0.44), being born abroad (OR 0.43; 95% CI 0.34-0.56), and residing in the South (OR 0.49; 95% CI 0.41-0.58) most reduce the probability of implementing numerous supportive practices (all three P < 0.001).    Conclusion: Socio-demographic factors contribute significantly to carrying out supportive practices. Future interventions should address the identified inequalities, prioritizing families most in need. Direct involvement of pediatricians is warranted given their favorable position for promoting positive behaviors. What is Known: • Several parental actions in the early life of a child are known to have positive effects on later child health and development. • While folic acid supplementation and exclusive breastfeeding have been promoted for years, other supporting actions are less well-known. What is New: • Rates of parental adherence to the different supportive actions varied greatly and actions were often scantly adopted. • Socio-demographic characteristics influenced adherence, with young, unemployed mothers with low educational levels, living in the South, or who were born abroad adhering significantly less.

Transitioning to adult mental health services for young people with ADHD: an Italian-based survey on practices for pediatric and adult services.

BACKGROUND: Supporting young ADHD patients in transition to adult services is essential. Yet, the low percentages of successful referrals and the issues reported by patients and clinicians stress the need for further attention to transitioning practices. The present study assessed the transitioning process of Attention-Deficit/Hyperactivity Disorder (ADHD) patients in Child and Adolescent Mental Health Services (CAMHS) and Adult Mental Health Services (AMHS) in the Italian territory. We asked child and adult psychiatrists to report the current state of services and their observations on limitations and possible future matters that must be addressed. METHOD: Seventy-seven centers (42 CAMHS, 35 AMHS) filled in a web-based survey in which they reported the number of ADHD patients, how many transitioning patients they had within the past year, and how they structured transition. RESULTS: A fragmented picture emerged from the survey. Lack of resources, training, and communication between services hinder the transition process, and many adult patients remain under CAMHS' care. While some services have a protocol, there is no structured guidance that can help improve integration and continuity of treatment. CONCLUSION: The observed situation reflects a need for improvement and standard guidelines to enable a successful transition process, considering clinicians' and patients' necessities.

Early detection of neurodevelopmental disorders in African children living in informal settlements in Nairobi.

BACKGROUND: Children in low-income and middle-income countries (LMICs) are at a substantially increased risk of delayed physical, emotional and sociocognitive outcomes, with consequential neurodevelopmental disorders. Evidence based, cost-effective and culturally appropriate screening tools are recommended for early identification of developmental disorders. METHODS: The present study aims to assess the feasibility of early screening for neurodevelopmental disorders in children living in informal settlements in Nairobi, Kenya (Korogocho). The selected tools (ie, the CDC checklist and the Modified Checklist for Autism in Toddlers, Revised (M-CHAT-R)), widely used in high-income countries, are applied in two different populations: one from Kenya (LMIC) and one from Italy, to compare the different scores. RESULTS: Of 509 children screened, 8.6% were classified at-risk based on the results of the screening tools. Significant risk factors are history of low birth weight and Apgar score, presence of neurological disorders, malnutrition and/or rickets, younger age of the child and older age of the mother. Caesarean section delivery, first pregnancy and mothers' older age were common risk factors among the Kenyan and the Italian samples. The Italian sample had a significantly greater rate of missed milestones. CONCLUSIONS: Our data demonstrate the feasibility of using the CDC and M-CHAT-R tools in informal settlement dwellers. Further studies are needed to explore the opportunity for early diagnosis of developmental disorders in LMICs.

[Migrate to be equal.] / Migrare per essere uguali.

Equitable access to healthcare is crucial to ensure the fundamental human right to health for all. However, the possibility to use in appropriate manner medical services (e.g., to access hospital) differs substantially across Italian regions. It is a situation, source of inequality, that has been known for some time and has not found a solution to date. In 2020, the pandemic year, 7.6% of hospital admissions occurred for patients residing in regions other than that of hospitalization. The starting regions with the highest mobility rate were Molise, Basilicata, Calabria and Abruzzo with a flight index of 28.1 (Molise)-16.1 (Abruzzo) for a total of 86,787 hospitalizations (16.8% of total national hospitalizations outside the region of residence). 58.7% of hospitalizations are for patients traveling from one of the regions bordering their residence, while 13.9% are for those who have crossed 2 regions and 27.4% at least 3 regions. The main cause of hospitalization is attributable to surgery for the replacement of major joints or reimplantation of the lower limbs with 124,860 discharges for hospitalized residents in their own region (16.1%), 16,996 hospitalized in a neighbouring region (20.4 %) and 8,019 hospitalized in a region far from their own (17.7%). The phenomenon of medical migration undermines the principles of universality, equality and fairness and it is therefore necessary to intervene to guarantee an unfulfilled right in its entirety.

National, longitudinal NASCITA birth cohort study: prevalence of overweight at 12 months of age in children born healthy.

OBJECTIVE: To estimate the prevalence of overweight at 12 months in an Italian birth cohort and to identify factors related to an increased likelihood of being overweight. METHODS: The Italian NASCITA birth cohort was analysed. Infants were classified as underweight (<5th), normal weight (5-84th) and overweight (≥85th centile) at 12 months of age according to the WHO percentiles of body mass index (BMI) and the prevalence of overweight was estimated. To test the association between the chance of being overweight and parental and newborn characteristics, and infant feeding, healthy newborns (no preterm/low birth weight and with no malformations), with appropriate-for-gestational-age birth weight were selected, and univariate and multivariate analyses were performed. RESULTS: The prevalence of overweight was 23.5% (95% CI 22.2% to 24.8%) in all cohort members with 12-month data (N=4270), and 23.1% in the appropriate-for-gestational age subsample (N=2835).A big infant appetite (OR 3.92, 95% CI 2.40 to 6.40) and living in southern Italy (OR 1.58, 95% CI 1.29 to 1.94) were the main variables associated with a greater likelihood of being overweight. Breastfeeding practice did not influence the chance of being overweight, but was associated with an increase (exclusive breast feeding for at least 6 months) or a decrease (breast feeding for at least 12 months) in BMI z score at 12 months. CONCLUSIONS: The sociodemographic factors (eg, area of residence, maternal employment status) seem to be the most relevant determinants influencing the chance of being overweight at 12 months. Early interventions, with particular attention to vulnerable families, may be helpful in preventing childhood and adult obesity.

National, longitudinal NASCITA birth cohort study to investigate the health of Italian children and potential influencing factors.

PURPOSE: The NASCITA Study, a national-level, population-based, prospective cohort study, was set up to better understand the early health status of Italian children, comprising their physical, cognitive and psychological development, and how it is affected by social and health determinants, including nurturing care. NASCITA will also assess geographical differences and disparities in healthcare. PARTICIPANTS: Participating family paediatricians from throughout Italy enrolled infants born during the enrolment period (April 2019-July 2020). The 5054 newborns seen by the 139 paediatricians for at least two visits, including the first well-child visit, and for whom parental consent was given, make up the baseline population. FINDINGS TO DATE: Mothers had a mean age at delivery of 33.0 years and tended to have a high or medium level of education (42.5% university and 41.7% high school degrees) and to be employed (69.7%). One-third (36.1%) took folic acid supplementation appropriately, and 6.5% smoked or consumed alcohol (10.0%) during pregnancy. One-third (31.7%) of deliveries were caesarean deliveries. Concerning the newborns, 5.8% had a low birth weight and 6.2% were born prematurely. The majority (87.7%) slept in the supine position, and 63.6% were exclusively breast fed at 1 month, with a decreasing north to south prevalence (χ2 t 52; p<0.001). Significant north-south differences were found in all areas, including parental education, behaviours in pregnancy and hospital practices. When compared with national level data, the cohort population's distribution, maternal sociodemographic characteristics and newborn physical characteristics reflect those of the Italian population. FUTURE PLANS: Data will continue to be collected during the well-child visits until the children are 6 years old, and multiple health outcomes will be studied, spanning child development and illness, as well as potentially related factors including caregiving routines. The findings will be used to develop specific interventions to improve children's health. TRIAL REGISTRATION NUMBER: NCT03894566.

European birth cohorts: a consideration of what they have addressed so far.

BACKGROUND: Knowing the research issues addressed by other cohorts when setting up new cohorts allows researchers to avoid unnecessary duplication of efforts, while permitting collaborations, including data merging data, to better tackle knowledge gaps. This study describes the topics addressed by European birth cohorts, the interaction between these cohort interests and aims, and describes the scientific publications deriving from the cohorts. METHODS: A previous study found 66 pregnancy and 45 birth cohorts in Europe. In this study, between August and October 2020, the predominant key areas addressed by the 45 birth cohorts identified in the previous study were evaluated, as were the publications found in PubMed that were associated with the 45 cohorts. A network analysis was performed to show the connections between the 13 key areas identified. A focus on a topic in common between two areas was provided, describing the related publications. RESULTS: A total of 1512 references were found in PubMed (148 publications per cohort). Thirteen predominant key areas were identified, the most common of which was "Environmental" (addressed by 20 cohorts). The Environmental, Genes, and Lifestyle exposure areas were the prevalent topics characterizing the network figure. The Environmental area had the largest number of interactions with the other areas, while the Prematurity area (4 cohorts) the least. The focus provided on smoking led to the comparison of 35 publications from the Environmental group of cohorts and 22 from the Prematurity group, but their objectives did not overlap. CONCLUSIONS: The results of this descriptive study show that the environment is a priority research area for cohorts in Europe and that cohorts with different research areas may have study issues in common, but may approach them from different viewpoints. Birth cohorts have wide-ranging aims and it would be almost impossible, and undesirable, to have perfectly overlapping and comparable objectives, but joining efforts would permit maximum use of available resources.

Changes in antiepileptic drug prescriptions over a decade in childbearing women in Lombardy region, Italy.

AIMS: To describe the antiepileptic drug (AED) prescription pattern in pregnant women and women of childbearing age in the 2010-2019 period in the Lombardy region, Italy. METHODS: The Lombardy region administrative healthcare databases (2010-2019) were analysed. AEDs were classified as drugs belonging to the N03A subgroup of the Anatomical Therapeutic Chemical Classification System. Women aged 15-49 years were considered as being of childbearing age, while exposure during pregnancy was estimated taking into account the 12 months before delivery (International Classification of Diseases, Ninth Revision, Clinical Modification, ICD-9-CM codes in the diagnosis record from 650 to 659). RESULTS: During 2019, 16 605 women of childbearing age (prevalence: 14.8‰) received at least 1 AED prescription. Pregabalin was the most widely used antiepileptic in women of childbearing age (22.3%), followed by valproic acid (20.0%). In 2010, the prevalence of valproic acid prescription to women of childbearing age was 30.2%; in 2019 this was 20.0%. In pregnant women, this prevalence was 24.9% in 2010 and 14.1% in 2019. Starting from 2017, levetiracetam and lamotrigine were the most commonly drugs prescribed to pregnant women. CONCLUSION: Despite the decrease in valproic acid prescription over time, this drug is still among the most used AEDs, in particular in women of childbearing age. Educational interventions for healthcare professionals and women are needed in order to reduce the risk of unplanned pregnancy.

Burnout in Intensive Care Unit Workers during the Second Wave of the COVID-19 Pandemic: A Single Center Cross-Sectional Italian Study.

The COVID-19 pandemic had a massive impact on the Italian healthcare systems, which became overwhelmed, leading to an increased risk of psychological pressure on ICU workers. The present study aimed to investigate the prevalence of distress (anxiety, depression and insomnia symptoms), burnout syndrome and resilience in healthcare workers during the COVID-19 pandemic and to detect potential factors associated with their psychological response. This cross-sectional, survey-based study enrolled 136 healthcare workers assisting COVID-19 patients in the new COVID-19 ward (Intensive Care Unit), at Milano Fiera, Lombardy. Participants completed an online survey that comprised different validated and standardized questionnaires: Maslach Burnout Inventory (MBI), Resilience Scale for adults (RSA), Hospital Anxiety and Depression scale (HADS) and Insomnia Severity Index (ISI). Socio-demographic and work characteristics were also collected. Out of 136 ICU specialists, there were 84 nurses (62%) and 52 physicians (38%). Over half (60%) met the criteria for burnout, with nearly the same percentages among nurses and physicians. Nurses reported significantly higher scores of anxiety and insomnia levels. Forty-five percent of participants reported symptoms of depression (of whom 13.9% in the clinical range) and most of the staff showed moderate to high levels (82.4%) of resilience. The COVID-19 pandemic can have a significant impact on ICU staff. Effective interventions are needed to maintain healthcare professionals' mental health and relieve burnout. Follow-up and tailored procedures should be provided to alleviate the psychological burden in the frontline staff at highest risk.

Distance learning in Italian primary and middle school children during the COVID-19 pandemic: a national survey.

BACKGROUND: School closure created difficulties for parents, who were asked to care for their children and help them with schooling, while working at home. We aimed to explore the experiences in organising school for children at home and its implications on children's psychological well-being and educational progress during the quarantine for the COVID-19 pandemic. METHODS: A nationwide online survey of mothers of primary and middle school students was conducted during the COVID-19 pandemic. Demographic data and information on distance learning organisation and children's attitudes and behavioural changes were collected. RESULTS: 2149 mothers completed the survey, with a final sample of 1601 subjects. Large differences between primary and middle school emerged: lessons were less organised and routines were more instable for the youngest, who could not pay attention for more than 20 min (28.3%) and needed breaks every 10 min (21.6%), with lower quality of learning (40.6%), increased restlessness (69.1%), and aggressiveness (33.3%). A large use of screens was reported, with an abuse in screen time in 2%. Two thirds of mothers did not approve of distance learning (72.2%) because of their role in replacing teachers (77.8%), the effort required (66%), and the great commitment required (78.3%). CONCLUSIONS: Distance learning increased educational deprivation and social inequalities, especially for the youngest children, who lost almost one year of school. The situation was even worse for children with disabilities, who were neglected by the institutions. This period should be considered as an opportunity to correct the weaknesses of our school system.

Psychological distress among Italians during the 2019 coronavirus disease (COVID-19) quarantine.

BACKGROUND: Quarantine as a preventive action to reduce people's exposure to a contagious disease has substantial psychological impact. We aimed to collect information on psychologically distressing experiences of Italians living in quarantine during the COVID-19 pandemic. METHODS: From 6 to 20 April 2020 participants filled out an online questionnaire. Demographic and physical symptoms data from the prior 14 days of quarantine were collected. Psychological impact of quarantine was assessed by the COVID-19 Peritraumatic Distress Index (CPDI). RESULTS: In all, 20,158 participants completed the online survey. Of these, 11,910 (59.1%) were from Lombardy, the region with 37.7% of positive cases identified during the survey period. 30.1% of responders were male. About half (55.9%) of responders were 18-50 years old, 54.3% had a tertiary level of education, 69.5% were workers, 84.1% were living in houses with ≥3 rooms, and 13.7% were living alone. 9.7% had had contact with COVID-19 positive people. Of all responders, 9978 (48.6%) reported a psychological impact, 8897 (43.4%) of whom reported mild or moderate and 1081 (5.2%) severe psychological impact. The multivariate analysis, after adjustments, showed that an increasing CPDI score was associated with gender (female), first-second educational level, being unemployed, living in a ≤2 room house, having had new health problems during the previous 14 days, and not having been out of the house in the previous week. Concerning the type of psychological distress, 2003 responders (9.9%) reported moderate to severe depressive symptoms, 1131 (5.5%) moderate to severe anxiety symptoms, and 802 (3.9%) moderate to severe physical symptoms. A positive correlation was found between responder rate (per 10.000 residents) and positive COVID-19 cases (per 10.000 residents) by region (rs = + 0.83, p = < 0.0001), and between responder rate and region latitude (rs = + 0.91, p = < 0.0001), with a greater response rate in the north. Considering Lombardy Region responders, a negative correlation between CPDI score and distance from place of residence to the red zone (Nembro-Alzano) was found. Higher prevalence of psychological distress was found up to 25 km away from the red zone and, in particular, severe distress up to 15 km. CONCLUSIONS: Policy makers and mental health professionals should be aware of quarantine's adverse mental health consequences. Factors influencing the success of quarantine and infection control practices for both disease containment and community recovery should be identified and additional support to vulnerable persons at increased risk of adverse psychological and social consequences of quarantine should be guaranteed.

Psychological distress in adults with and without cystic fibrosis during the COVID-19 lockdown.

BACKGROUND: Hundreds of papers have been published on the COVID-19 pandemic, and several of them on psychological themes connected with it, but very little is so far known on how adult patients with Cystic Fibrosis (pwCFs) are coping with this dramatic event. METHODS: An online questionnaire was developed according to the Italian validated COVID-19 Peritraumatic Distress Index (CPDI) and addressed to the general population (GP). A similar questionnaire, augmented with CF specific questions, targeted pwCFs. The two web-based surveys were accessible for some weeks during the lockdown mandated by the Italian government. RESULTS: The CF questionnaire was completed by 712 adult pwCFs (422 females), matched for sex and age with a 1/5 ratio to GP questionnaire respondents. Mild or medium distress affected 40.2% of pwCFs and 43.9% of GP controls, severe distress 5.3% of pwCFs and 6.2% of GP controls. The level of psychological distress was not correlated with the degree of pulmonary function impairment. When symptoms of anxiety and depression, and physical manifestations were independently analyzed, the control group featured a 55% higher level of mild-moderate anxiety symptoms. Signs of psychological distress, symptoms of anxiety and depression, and physical manifestations were significantly more frequent in female pwCFs compared to males, similarly to GP. CONCLUSION: Adult pwCFs seem to have equal, and in some domains, lower levels of psychological distress than GP controls. This might be sustained by lifelong experiences in coping with the demands of their chronic disease. These results may orient future psychological interventions.

Low-Risk Planned Out-of-Hospital Births: Characteristics and Perinatal Outcomes in Different Italian Birth Settings.

BACKGROUND: The present observational study aimed to describe women and delivery characteristics and early birth outcomes according to planned out-of-hospital delivery and to compare this information with comparable planned in-hospital deliveries. METHODS: 1099 healthy low-risk women who delivered out-of-hospital between 2014 to 2018, with a gestational age of 37-42 completed weeks of pregnancy, with single, vertex babies whose birth was expected to be vaginal and spontaneous were enrolled. Moreover, a case-control study was designed comparing characteristics of these births to a matched 1:5 sample. RESULTS: living in a medium city (RR 1.81, 95% CI 1.19-2.74), being multiparous (RR 1.66, CI 1.09-2.51), having the first child at ≥35 years old (RR 1.84, CI 1.02-3.33), not working (RR 1.77, CI 1.06-2.96), not being omnivorous (RR 1.80, CI 1.08-3.00), and not smoking (RR 2.53, CI 1.06-6.07) were all related to an increased chance of delivering at home compared to in a freestanding midwifery unit. The significant factors in choosing to give birth out-of-hospital instead of in-hospital were living in a large or medium city (OR 2.20; 1.75-2.77; OR 2.41; 1.93-3.02) and having a secondary or higher level of education (OR > 2 for both parents). Within the first week of delivery, 6 of 1099 mothers and 19 of 1099 neonates were hospitalized. CONCLUSIONS: out-of-hospital births in women with low-risk pregnancies is a possible option that needs to be planned, monitored, regulated, and evaluated according to healthcare control systems in order to work, as in hospitals, for the safest and most effective care to a mother and her neonate(s).

Can we still do something-and what?-for a seemingly missing syndrome?

BACKGROUND: Although several modifiable risk factors have been identified, and prone and side sleep positions were identified as preventing sudden infant death syndrome (SIDS), the epidemiology of sudden unexpected deaths in infancy (SUDI), which includes SIDS, has not unchanged in over a decade. What can be done? METHODS: Italian infant mortality rates were analysed between 1996 and 2015. RESULTS: Between 1996 and 2015 in Italy 1152 SUDI deaths were reported in infants less than one year old. SUDI decreased substantially from 18 in 1996 to 10.2 deaths per hundred live births in 2015 (- 43%), the contribution was the change in the SIDS rate from 11.3 to 4.1 (- 64%). However, since 1004 main and SIDS rates have not changed. CONCLUSION: Interventions that support safe sleep must be maintained, but research is still needed since although these dramatic deaths have been reduced their causes remain unknown. The challenge is now to shift their trend which has been constant for too long.

A Web-Based Form With Interactive Charts Used to Collect and Analyze Data on Home Births in Italy.

BACKGROUND: The use of Web-based forms and data analysis can improve the collection and visualization of data in clinical research. In Italy, no register exists that collects clinical data concerning home births. OBJECTIVE: The purpose of this study was (1) to develop a Web portal to collect, through a Web-based form, data on home births in Italy and (2) to provide those interested with a graphic visualization of the analyses and data collected. METHODS: Following the World Health Organization's guidelines, and adding questions based on scientific evidence, the case report form (CRF) on the online form was drafted by midwives of the National Association of Out-of-Hospital Birth Midwives. During an initial phase, a group of midwives (n=10) tested the CRF, leading to improvements and adding the necessary questions to achieve a CRF that would allow a more complete collection of data. After the test phase, the entire group of midwives (n=166) registered themselves on the system and began filling out birth questionnaires. In a subsequent phase, the administrators of the portal were able to view the completed forms in a graphic format through the use of interactive maps and graphs. RESULTS: From 2014 to 2016, 58 midwives included 599 birth questionnaires via the Web portal; of these, 443 were home-based, 76% (321/424) of which were performed at home and 24% (103/424) at a midwifery unit. Most of the births assisted (79%, 335/424) were in northern Italy, and the average ages of the mother and father were 33.6 (SD 4.7) years and 37.0 (SD 5.6) years, respectively. CONCLUSIONS: We developed an innovative Web-based form that allows, for the first time in Italy, the collection of data on home births and births in the midwifery unit. Furthermore, the data collected are viewable online by the midwives through interactive maps and graphs that allow them to have a general and continuously updated view of the situation of out-of-hospital births performed by the National Association of Out-of-Hospital Birth Midwives. The future goal is to be able to expand this data collection to all out-of-hospital births throughout the national territory. With an increase in the number of enrolled midwives, it would be possible to use the portal as a Web-based form and also as a portal for sharing resources that would help midwives in their clinical practice.

Perinatal outcome and healthcare resource utilization in the first year of life after antiepileptic exposure during pregnancy.

Healthcare administrative databases of Italy's Lombardy Region were analyzed with the aim to assess perinatal outcomes and healthcare resource utilization during the first year of life in infants exposed to antiepileptic drugs (AEDs) during pregnancy. Drug prescriptions dispensed in the 12 months before delivery to women, who delivered between 2005 and 2011, were analyzed. Neonates were classified as cases if exposed to AEDs, and each case was randomly matched to seven controls. No significant differences were observed in the risk of congenital malformations between 526 cases and 3682 controls except for valproic acid (odds ratio (OR): 2.29; 95% confidence interval (CI): 1.24-4.22) where cases were more likely to be small for gestational age (χ2 = 7.66; p = 0.006). Cases also had a higher probability than controls of needing at least one specialist visit in a child neuropsychiatry outpatient service (OR: 1.74; 95% CI: 1.22-2.49).

Antiepileptic drug use in Italian children over a decade.

PURPOSE: The aim of the study was to evaluate prescription profiles of antiepileptic drugs (AEDs) and to assess hospitalizations and specialist visits in pediatric patients with epilepsy. METHODS: The data sources were administrative health databases of Italy's Lombardy Region, which collect prescriptions for drugs, diagnostic tests, specialist visits, and hospital discharge forms. All patients aged 0-16 years with at least seven AED (group N03A of the International Anatomical Therapeutic Chemical Classification) prescriptions over two consecutive years between 2003 and 2010 were identified and classified as prevalent or incident cases (no prescriptions in two previous years). The first prescription to incident cases was analyzed. For each incident case, drug prescriptions, specialist visits, diagnostic tests, and hospitalizations in the 24 months following the first (index) prescription were monitored. RESULTS: A total of 6527 incident cases (5.4/10,000 person-years, 95% CI 5.4-5.5) were identified. Valproic acid and carbamazepine were the most prescribed drugs (65.9 and 15.0%, respectively). The use of newer AEDs increased over time. In the 24-month observation period, 74% of incident cases continued the treatment with the index AED. The percentage of cases who changed therapy was higher in preschoolers (34%) and decreased with age. In all, 21% of incident cases were hospitalized for epilepsy and 86% had a specialist visit in the 24 months after the first AED prescription. CONCLUSIONS: In conclusion, older AEDs, particularly valproic acid, remained the first therapeutic approach to pediatric epilepsy in Italy. For three quarters of cases, the initial AED treatment was likely effective and well tolerated.

Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies.

PURPOSE: To evaluate the quality of data reporting and statistical methods performed in drug utilization studies in the pediatric population. METHODS: Drug utilization studies evaluating all drug prescriptions to children and adolescents published between January 1994 and December 2011 were retrieved and analyzed. For each study, information on measures of exposure/consumption, the covariates considered, descriptive and inferential analyses, statistical tests, and methods of data reporting was extracted. An overall quality score was created for each study using a 12-item checklist that took into account the presence of outcome measures, covariates of measures, descriptive measures, statistical tests, and graphical representation. RESULTS: A total of 22 studies were reviewed and analyzed. Of these, 20 studies reported at least one descriptive measure. The mean was the most commonly used measure (18 studies), but only five of these also reported the standard deviation. Statistical analyses were performed in 12 studies, with the chi-square test being the most commonly performed test. Graphs were presented in 14 papers. Sixteen papers reported the number of drug prescriptions and/or packages, and ten reported the prevalence of the drug prescription. The mean quality score was 8 (median 9). Only seven of the 22 studies received a score of ≥10, while four studies received a score of <6. CONCLUSIONS: Our findings document that only a few of the studies reviewed applied statistical methods and reported data in a satisfactory manner. We therefore conclude that the methodology of drug utilization studies needs to be improved.

Geographical epidemiology of antibacterials in the preschool age.

BACKGROUND: Thematic maps allow a more rapid and immediate reading of the geographical differences in the distribution of data referred to a specific territory. The aim of this study was to show, for the first time, the application of some statistical and cartographic tools in the analysis of drug utilization in the pediatric population of an Italian region, and to assess the intra-regional difference in the antibiotic prescriptions. METHODS: To assess the type of geographic distribution of the prescriptions, the analyses were based on the standardized prevalence rate (z-score) calculated at the local health unit, health district, and municipality levels. Pearson's coefficient of correlation was used to evaluate the correlation with hospitalization and the Moran's I index was used to evaluate the existence of spatial autocorrelation. With the use of Getis-Ord's G statistic, clusters of areas with high and low levels of prevalence were identified and mapped. The probability of receiving at least one prescription of antibacterials during the year for all the children included in the study was evaluated with a logistic regression model. RESULTS: With the use of the maps it was possible to see that the prescriptions were not correlated with the health status of the population, but with the tendency of the pediatrician to prescribe drugs. This was also confirmed by the logistic regression model constructed to estimate the probability of receiving at least one prescription of antibacterials considering, as independent variables: age, sex, prevalence of hospitalizations in the district of residence, prescriptive attitude of the pediatrician, sex of the pediatrician, pediatrician's age group, and duration of the pediatrician's contract with the local health unit (LHU). CONCLUSIONS: The priority actions to rationalize the use of antibacterials in the preschool age should concentrate on the active participation of the pediatricians in permanent education activities. Moreover, the competent authorities should increasing their efforts to limit unnecessary prescriptions and increase appropriateness of prescribing.