Insomnia in the Italian Population During Covid-19 Outbreak: A Snapshot on One Major Risk Factor for Depression and Anxiety

Objectives: One of the largest clusters of Covid-19 infections was observed in Italy. The population was forced to home confinement, exposing individuals to increased risk for insomnia, which is, in turn, associated with depression and anxiety. Through a cross-sectional online survey targeting all Italian adult population (≥18 yrs), insomnia prevalence and its interactions with relevant factors were investigated. Methods: The survey was distributed from 1st April to 4th May 2020. We collected information on insomnia severity, depression, anxiety, sleep hygiene behaviors, dysfunctional beliefs about sleep, circadian preference, emotion regulation, cognitive flexibility, perceived stress, health habits, self-report of mental disorders, and variables related to individual difference in life changes due to the pandemic's outbreak. Results: The final sample comprised 1,989 persons (38.4 ± 12.8 yrs). Prevalence of clinical insomnia was 18.6%. Results from multivariable linear regression showed that insomnia severity was associated with poor sleep hygiene behaviors [β = 0.11, 95% CI (0.07–0.14)]; dysfunctional beliefs about sleep [β = 0.09, 95% CI (0.08–0.11)]; self-reported mental disorder [β = 2.51, 95% CI (1.8–3.1)]; anxiety [β = 0.33, 95% CI (0.25–0.42)]; and depression [β = 0.24, 95% CI (0.16–0.32)] symptoms. Conclusion: An alarming high prevalence of clinical insomnia was observed. Results suggest that clinical attention should be devoted to problems of insomnia in the Italian population with respect to both prevention and treatment

First‐line nab‐paclitaxel plus carboplatin for patients with advanced non‐small cell lung cancer: results of the NEPTUN study

Abstract Background Platinum‐based chemotherapy remains a first‐line standard of care for approximately 30% of patients with non‐small cell lung cancer (NSCLC) not harboring a druggable alteration. Favorable efficacy and safety of the nab‐paclitaxel/carboplatin (nab‐P/C) combination was shown in the pivotal phase 3 trial. However, information on effectiveness of nab‐P/C in a real‐world setting in Germany is missing. The NEPTUN study prospectively investigated the effectiveness and safety of nab‐P/C in patients with advanced NSCLC in a real‐world setting. Methods Patients with advanced or metastatic NSCLC received first‐line nab‐P/C according to clinical routine. The primary endpoint was 6‐month progression‐free survival rate (PFS6). Other endpoints included further effectiveness parameters, safety and quality of life. Data were analyzed descriptively. Results 408 patients were enrolled. PFS6 was 40.8% (95% confidence interval [CI], 35.3–46.2); median PFS was 5.2 months (95% CI, 4.5–5.7). overall response rate was 41.5% (95% CI, 36.3–46.8). Median overall survival (OS) was 10.5 months (95% CI, 9.2–11.6). Subgroup analyses revealed median OS for squamous versus non‐squamous histology (11.8 months [95% CI, 9.2–13.8] vs. 9.6 months [95% CI, 7.7–11.2]) and age ≥70 versus <70 years (11.7 months [95% CI, 9.4–14.3] vs. 9.6 months [95% CI, 7.5–11.2]). Most common treatment‐emergent adverse events (TEAEs) were anemia (26.5%), leukopenia (25.7%), and thrombocytopenia (16.6%). Mostly reported grade 3/4 TEAEs were leukopenia (10.2%), anemia (8.6%), and pneumonia (5.1%). nab‐paclitaxel‐related deaths as reported by the investigator occurred in 0.8% of patients. Conclusion These real‐world data support the effectiveness and safety of nab‐P/C as first‐line treatment for patients with advanced NSCLC independent of tumor histology. The results are comparable with the pivotal phase 3 trial. No new safety signals emerged

Sleep characteristics in Italian children during home confinement due to COVID-19 outbreak

Objective: Italy faced one of the first large clusters of COVID-19 infections worldwide. Home confinement and social distancing could have negatively impacted sleep habits and prevalence of sleep disorders in children, which may be also linked with altered emotional processes. The present study focused on clinical aspects related to sleep, insomnia and emotions in Italian children aged 0-to-12 years during home confinement due to COVID-19 outbreak. Method: An online survey was systematically distributed in all Italian territories by contacting regional offices of the Italian Ministry of Instruction, University and Research (MIUR) and schools with available contact. All respondents had to be parents of at least one child aged 0 to 12 years old. Information on sociodemographic variables, sleep habits, sleep health behaviors, sleep disorders and mood were collected. Results: Parents of 2361 children (mean age: 8.1 ± 2.62 years; 1148 females; 1213 males) answered the survey. 1.2% of children was between 0 and 2 years old; 15.3% within 3 to 5 years and 83.3% within 6 and 12 years. In all group ages, late bedtime was observed (most of them after 9 p.m.). 59.4% of all children presented at least one clinical diagnostic criterion for childhood insomnia. Logistic regression model showed that presence of at least one criterion for childhood insomnia was associated to younger age, negative mood, current parental insomnia, being the only child, presence of any other sleep disorder, and sleep hygiene behaviors. Conclusions: Data indicate an alarming increase of prevalence of insomnia related problems in Italian children during home confinement with respect to previous data. This was found to be associated with poor sleep hygiene and negative mood. Clinical programs targeting insomnia, sleep health behaviors and emotional processes should be implemented in pediatric primary care in order to prevent the development of sleep problems in a post-pandemic situation

Development and validation of a prognostic model for survival in patients treated with venoarterial extracorporeal membrane oxygenation: the PREDICT VA-ECMO score

Aims: Several scoring systems have been introduced for prognostication after initiating venoarterial extracorporeal membrane oxygenation (VA-ECMO) therapy. However, static scores offer limited guidance once VA-ECMO is implanted, although continued allocation of healthcare resources is critical. Patients requiring continued VA-ECMO support are extremely unstable, with minimal heart function and multi-organ failure in most cases. The aim of the present study was to develop and validate a dynamic prognostic model for patients treated with VA-ECMO. Methods and results: A derivation cohort included 205 all-comers undergoing VA-ECMO implantation at a tertiary referral hospital (51% received VA-ECMO during resuscitation and 43% had severe shock). Two prediction models based on point-of-care biomarkers were developed using penalised logistic regression in an elastic net approach. A validation cohort was recruited from an independent tertiary referral hospital. Comparators for the prediction of hospital survival were the SAVE score (area under the receiver operation characteristic curve (AUC) of 0.686), the SAPS score (AUC 0.679), the APACHE score (AUC 0.662) and the SOFA score (AUC 0.732) in 6-hour survivors. The 6-hour PREDICT VA-ECMO score (based on lactate, pH and standard bicarbonate concentration) outperformed the comparator scores with an AUC of 0.823. The 12-hour PREDICT VA-ECMO integrated lactate, pH and standard bicarbonate concentration at 1 hour, 6 hours and 12 hours after ECMO insertion allowed even better prognostication (AUC 0.839). Performance of the scores in the external validation cohort was good (AUCs 0.718 for the 6-hour score and 0.735 for the 12-hour score, respectively). Conclusion: In patients requiring VA-ECMO therapy, a dynamic score using three point-of-care biomarkers predicts hospital mortality with high reliability. Furthermore, the PREDICT scores are the first scores for extracorporeal cardiopulmonary resuscitation patients