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Background Early start of highly active antiretroviral therapy (HAART) in perinatally HIV-1 infected children is the optimal strategy to prevent immunological and clinical deterioration. To date, according to EMA, only 35% of antiretroviral drugs are licenced in children Methods An observational retrospective study investigating the rate and the outcomes of off-label prescription of HAART was conducted on 225 perinatally HIV-1 infected children enrolled in the Italian Register for HIV Infection in Children and followed-up from 2001 to 2018. Results 22.2% (50/225) of included children were receiving an off-label HAART regimen at last check. Only 26% (13/50) of off-label children had an undetectable viral load (VL) before the commencing of the regimen and the 52.0% (26/50) had a CD4 + T lymphocyte percentage > 25%. At last check, during the off label regimen, the 80% (40/50) of patients had an undetectable VL, and 90% (45/50) of them displayed CD4 + T lymphocyte percentage > 25%. The most widely used off-label drugs were: dolutegravir/abacavir/lamivudine (16%; 8/50), emtricitbine/tenofovir disoproxil (22%; 11/50), lopinavir/ritonavir (20%; 10/50) and elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (10%; 10/50). At logistic regression analysis, detectable VL before starting the current HAART regimen was a risk factor for receiving an off-label therapy (OR: 2.41; 95% CI 1.13–5.19; p = 0.024). Moreover, children Conclusion The prescription of an off-label HAART regimen in perinatally HIV-1 infected children was common, in particular in children with detectable VL despite previous HAART and in younger children, especially those receiving their first regimen. Our data suggest similar proportions of virological and immunological successes at last check among children receiving off-label or on-label HAART. Larger studies are needed to better clarify efficacy and safety of off-label HAART regimens in children, in order to allow the enlargement of on-label prescription in children.

There is currently an experts' agreement discouraging interruption of antiretroviral treatment (ART) during the first trimester of pregnancy in women infected with human immunodeficiency virus type 1 (HIV-1). However, this recommendation is poorly supported by data. We evaluated the effects of discontinuing ART during pregnancy on the rate of mother-to-child transmission.Logistic regression models were performed in a prospective cohort of 937 children who were perinatally exposed to HIV-1 to estimate adjusted odds ratios for confounding factors on mother-to-child transmission, including maternal interruption of ART.Among 937 pregnant women infected with HIV-1, ART was interrupted in 81 (8.6%) in the first trimester and in 11 (1.2%) in the third trimester. In the first trimester, the median time at suspension of ART was 6 weeks (interquartile range [IQR], 5-6 weeks) and the time without treatment was 8 weeks (IQR, 7-11 weeks). In the third trimester, the median time at suspension of ART was 32 weeks (IQR, 23-36 weeks) and the time without treatment was 6 weeks (IQR, 2-9 weeks). The plasma viral load was similar in women who had treatment interrupted in the first trimester and in those who did not have treatment interrupted. Overall, the rate of mother-to-child transmission in the whole cohort was 1.3% (95% confidence interval [CI], 0.7%-2.3%), whereas it was 4.9% (95% CI, 1.9%-13.2%) when ART was interrupted in the first trimester and 18.2% (95% CI, 4.5%-72.7%) when ART was interrupted in the third trimester. In the multiple logistic regression models, only interruption of ART during either the first or the third trimester, maternal mono- or double therapy, delivery by a mode other than elective cesarean delivery, and a viral load at delivery4.78 log(10) copies/mL were independently associated with an increased rate of mother-to-child transmission.Discontinuing ART during pregnancy increases the rate of mother-to-child transmission of HIV-1, either when ART is stopped in the first trimester and subsequently restarted or when it is interrupted in the third trimester. This finding supports recommendations to continue ART in pregnant women who are already receiving treatment for their health.

Background In the Highly Active Antiretroviral Therapy (HAART) era, the prognosis of children perinatally infected with HIV-1 has significantly improved, so the number of perinatally-infected females entering child-bearing age and experiencing motherhood is increasing. Methods A description of the medical history and pregnancy outcomes of women with perinatal acquired HIV-1 infection enrolled in the Italian Register for HIV infection in Children. Results Twenty-three women had 29 pregnancies. They had started an antiretroviral therapy at a median of 7.7 years (interquartile range, IQR 2.3 - 11.4), and had experienced a median of 4 therapeutic regimens (IQR 2–6). Twenty women (87%) had taken zidovudine (AZT) before pregnancy, in 14 cases as a starting monotherapy. In 21 pregnancies a protease inhibitor-based regimen was used. At delivery, the median of CD4+ T lymphocytes was 450/μL (IQR 275–522), and no viral load was detectable in 15 cases (reported in 21 pregnancies). Twenty-eight children were delivered through caesarean section (median gestational age: 38 weeks, IQR 36–38, median birth weight: 2550 grams, IQR 2270 – 3000). Intravenous AZT was administered during delivery in 26 cases. All children received oral AZT (median: 42 days, IQR 31 – 42), with no adverse events reported. No child acquired HIV-1 infection. Conclusions Despite a long history of maternal infection, multiple antiretroviral regimens and, perhaps, the development of drug-resistant viruses, the risk of mother-to-child transmission does not seem to have increased among the second-generation of HIV-1 exposed infants.

Aims: The aim of this study was to analyse the trend and characteristics of psychiatric consultations in 9 Italian hospital emergency departments (HEDs) during the lockdown and post-lockdown periods of 2020, compared with the equivalent periods in 2019. Methods: Information on HEDs psychiatric consultations of patients was collected between March 9, 2020 and June 30, 2020 and during the same period of the previous year. We investigated changes between the two years in the number of consultations, in the characteristics of patients accessing HEDs and in the drug prescriptions dispensed. Joinpoint models were used to identify changes in the weekly trend of HED psychiatric consultations over the same year and between years. Results: As compared with 2019, a 37.5% decrease number of psychiatric consultations was found in the lockdown period and 17.9% decrease after the lockdown. The number of individual patients seen in HEDs for psychiatric consultations decreased by 34.9% during the lockdown and 11.2% after the lockdown. Such decreases occurred in all but one centre. The analysis of the weekly trend of consultations in 2020 revealed a significant percentage change in the number of consultations occurring from March 11, 2020 (week 11) to May 5, 2020 (week 18), followed by a more gradual, non-significant increase. The demographic characteristics and the clinical history of patients were similar in the years 2020 and 2019, except for a higher percentage of patients with previous admissions to acute psychiatric wards (GPHUs) during the lockdown period (61.1% vs 56.3%; p=0.019) and a lower percentage after the lockdown (59.7% vs 64.7%; p =0.034). As to psychiatrist report after the consultation, during the lockdown there was a sharp increase in the diagnosis of substance use disorders, while after the lockdown a higher manic episodes and suicidal ideation or attempts was found. In particular, a 3.4% decline was observed in suicidal ideation and planning during the lockdown, followed by an upward rebound of the same after the lockdown (+3.4%), accompanied by an increase in suicide attempts (+2.3%). Lastly, during the lockdown the prescriptions of antipsychotics increased by 5.2% and that of benzodiazepines by 4.1%, with a similar trend after the lockdown. Notably, after the lockdown, the number of compulsory admissions were substantially higher than the equivalent period in 2019. Conclusions: Our results show a relevant decline in the number of psychiatric consultations during and after the lockdown, compared with the corresponding periods of 2019. An increase in consultations for mania and suicidality problems occurred at the end of the restriction period, suggesting that the attention of mental health services should remain high.

Aims To analyze the hospital emergency department (HED) consultations for schizophrenia-spectrum disorders in nine Italian hospitals during the 2020 lockdown and postlockdown periods, compared to the equivalent periods in 2019. Methods Characteristics of consultations, patients, and drug prescriptions were analyzed. Joinpoint models were used to identify changes in the weekly trend of consultations. Results During the 2020 lockdown the overall number of HED consultations for schizophrenia decreased by 40.7% and after the lockdown by 12.2% compared with 2019. No difference was found in the proportion of consultations that led to GHPU admissions or compulsory admissions. Suicidality rates did not differ across the two years, with the exception of ideations and plans (+5.9%) during the postlockdown period. We found an increase in benzodiazepine prescriptions in 2020 during the lockdown and postlockdown periods (+10.6% and +20.8%, respectively), and a decrease of prescriptions for short-acting sedative agents in the postlockdown period (–7.9%). An increase in the weekly trend of consultations occurred from March 11 to 17 (week 11) till June 26 to 30 (week 26). As a result, the initial gap in the number of consultations between the 2 years canceled out at the end of June. Conclusions HED consultation rate for schizophrenia-spectrum disorders declined consistent with that of other psychiatric disorders. In the postlockdown period, the growth of suicidal ideation/planning and increase in the prescriptions of anxiolytic-sedating drugs may foreshadow that for some schizophrenia patients the exit from the lockdown period is not liberating, but rather a source of agitation or perturbation.

AIM The aim of the present study was to detect factors associated with duration of untreated illness (DUI) in bipolar disorder (BD). METHOD A total of 1575 patients were selected for the purposes of the study. Correlation analyses were performed to analyse the relation between DUI and quantitative variables. The length of DUI was compared between groups defined by qualitative variables through one-way analyses of variance or Kruskal-Wallis's tests according to the distribution of the variable. Linear multivariable regressions were used to find the most parsimonious set of variables independently associated with DUI: to this aim, qualitative variables were inserted with the numeric code of their classes by assuming a proportional effect moving from one class to another. RESULTS An inverse significant correlation between length of DUI and time between visits in euthymic patients was observed (r = -.52, P

Objective: Postoperative cognitive decline (POCD) is known to occur quite frequently after a cardiac surgery, especially in older population. Few studies specifically focused on its incidence and characteristics in gynecological setting. Methods: Current opinions and future applications of POCD studies in gynecological setting have been discussed. Result: There are still many questions and issues about POCD in gynecological setting that remain unanswered as well as numerous research fields that have not been still explored. In particular, from this article emerges the need of further studies in gynecological setting focusing on: (a) the evaluation of long-term effect of POCD (e.g. over 3 months after surgery); (b) elderly population; (c) a wide range of cognitive functions (memory, attention, concentration, orientation, etc.); (d) the evaluation of risk and protective factors for subsequent POCD development; (e) the relationships between POCD and previous psychological or neuroendocrine factors; (f) the difference on POCD outcomes between different anaesthesia and disorders. Conclusion: Promoting studies on this topic is significant for the reduction of sociosanitary costs, mortality rates, social dependences and the likelihood of comorbidity.

Delirium is a severe neuropsychiatric syndrome characterized by inattention and global cognitive dysfunction in the setting of an acute medical illness, medical complication, drug intoxication or drug withdrawal. The most important risk factors are advanced age and dementia whereas pain, dehydration, infections, stroke, metabolic disturbances, and surgery are the most common triggering factors. Although delirium is a common clinical syndrome in different setting of care (acute care hospitals, inpatient rehabilitation facilities, nursing homes, and hospices) it often remains under-recognised, poorly understood and not adequately managed then there exists a clear need for improved understanding to overcome cultural stereotypes and for the development and dissemination of a comprehensive model of implementation of general good practice points. A network of Italian national scientific societies was thus convened (1) to develop a collaborative multidisciplinary initiative report on delirium in the elderly hospitalized patients, (2) to focus the attention of health care personnel on prevention, diagnosis and therapy of patients suffering from delirium, and (3) to make the health services research community and policy-makers more aware of the potential risks of this condition providing a reference for training activities and data collection.

The purpose of this study was to assess the interrelation between cortical, cardiovascular, behavioural, and psychological responses to acute stressors in a large sample of healthy individuals. To date, there are only preliminary evidences for a significant association among these psychophysiological indexes during a stress task. 65 participants completed psychological questionnaires (Beck Depression Inventory and State-Trait Anxiety Inventory) and underwent a psychosocial math stress task, consisting of a control and an experimental (i.e. stressful) condition. Prefrontal and autonomic activities were recorded using respectively a 2-channel near-infrared spectroscopy (NIRS) device and a portable ECG monitoring system. Results evidenced an increased activation of both frontal areas assessed by NIRS, and a positive association between the right NIRS channel and heart rate changes from baseline, during both control and experimental conditions. Subjective stress increased during the procedure, reaching its maximum during the experimental condition. Behavioural performances during the task (e.g. response time) did not correlate with anxiety or depression. Autonomic data evidenced, as expected, an overall reduction of vagal tone during the experimental condition. Finally, severity of depressive and anxious symptoms predicted an increase in parasympathetic activity both at rest and during the task, even when controlling for respiration rate. Results support the hypothesis of an integration between right sectors of frontopolar or dorsolateral PFC and cardiac regulation. Trait anxiety and depression predicted an increase in vagal tone during the entire procedure. The implication of these findings is discussed.

SUMMARYObjective — This study explored the effectiveness of a psychoeducational family intervention for schizophrenia on patients' clinical status and disability and relatives' burden and perceived support. Methods — The study has been carried out in 17 mental health centres. In each of them, 2 professionals were trained in a psychoeducational intervention and applied it for six months with families of users with schizophrenia. At baseline and six months later, patients' clinical status and disability, and relatives' burden, social network and professional support were assessed by validated tools. Results — Of the seventy-one recruited families, 48 (68%) completed the intervention. At six months, a significant improvement was found in patients' clinical status and social functioning, as well as in relatives' burden and social and professional support. In particular, the percentage of patients with poor or very poor global social functioning dropped from 50% to 27% at six months. Forty percent of patients and 45% of relatives reported a significant improvement in their social contacts over the intervention period. Conclusions — The results of this study confirm the hypothesis that psychoeducational family interventions may have a significant effect on social outcome and family burden in schizophrenia when provided in routine conditions.Declaration of Interest: none of the authors has had any interest or he/she has received any form of support, including that from drug companies and honoraria for lectures and consultancies, potentially in conflict with this scientific work. None of the authors has received any form of fee for his/her participation in this study. This study was supported by grants received from the “M. Lugli” Foundation (grant n. 2/18/8) and from the National Institute of Health, Italy (grant no. 1AL/F3).

SUMMARYAims – This study aims to explore: a) the feasibility of psycho-educational interventions for families of users with schizophrenia in clinical practice by trained staff; b) the benefits and problems encountered by professionals in the use of these interventions. Methods – 46 professionals from 23 Italian Mental Health Sen'ices (MHS) attended at a three-module training course in psycho-educational interventions and four supervisions in the subsequent year. Following the course, participants provided the intervention to families of users with schizophrenia. The difficulties and benefits encountered by trainees to use the intervention were registered on the Family Intervention Schedule.Results – 83% of the participants completed the training course. Following the course, the intervention started in 71 families from 17 MHS. 76% of trainees provided the intervention to 2-5 families, while 13% of them only held informative sessions on schizophrenia. During the supervision period, the organisational difficulties experienced by the professionals were stable, while the benefits increased. Differences in benefits and difficulties were detected in relation to the trainees’ experience and professional roles. Conclusions – It is possible to introduce psycho-educational interventions in MHS after a relatively brief period of training and supervision of the staff. Organisational difficulties need to be addressed to increase the dissemination of these interventions on a large scale.Declaration of Interest: None of the authors has had any interest or he/she has received any form of support, including that from drug companies and honoraria for lectures and consultancies, potentially in conflict with this scientific work. None of the authors has received any form of fee for his/her participation in this study. This study was supported by grants received from the “M. Lugli” Foundation (grant n. 2/18/8) and from the National Institute of Health, Italy (grant no. 1AL/F3).

Dopamine impairments occur in anorexia nervosa. The aim of this study was to see whether treatment with the atypical dopamine antagonist antipsychotic olanzapine improves the disorder. Thirty anorexics, 18 restricted and 12 bingeing-purging, underwent a 3-month course of cognitive behavioral therapy, plus at random and double-blinded oral olanzapine (2.5 mg for 1 month, 5 mg for 2 months) in half and oral placebo in the other half of them. BMI, psychopathological aspects (eating disorder inventory, Hamilton Rating Scale, Buss-Durkee Rating Scale, Yale Brown Cornell for Eating Disorders Rating Scale, temperament-character inventory), and homovanillic acid blood concentrations for dopamine secretion, were monitored at baseline and then monthly during the trial. At the end of the trial BMI, total eating disorder inventory, total Yale Brown Cornell for Eating Disorders Rating Scale, Buss-Durkee Rating Scale, Hamilton Rating Scale scores and in olanzapine-treated patients the subitems of eating disorder inventory ineffectiveness and maturity fear, of Buss-Durkee Rating Scale direct aggressiveness, of temperament-characteristic inventory persistence had improved significantly. When stratified for anorexia nervosa subtype, BMI changes were significant among anorexia nervosa bingeing-purging patient, 'depression' (Hamilton Rating Scale) and 'direct aggressiveness' (Buss-Durkee Rating Scale) among anorexia nervosa bingeing-purging patients, 'persistence' (temprerament-characteristic inventory), among anorexics restricted patients, with a trend toward significance for obsessivity-compulsivity (Yale Brown Cornell for Eating Disorders Rating Scale). homovanilic acid blood levels increased significantly in the cognitive behavioral therapy+olanzapine group. No correlations were observed between homovanilic acid concentrations and psychopathological parameters. The pharmacological treatment can significantly improve specific aspects of anorexia nervosa.