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IntroductionPolypharmacy is associated with an increased risk of adverse patient outcomes across various settings, including inpatient care. To enhance the appropriateness of medication therapy management for patients during hospital stays, computerised interventions have shown promise with regard to patient safety. This study assesses whether the implementation of a clinical decision support system will optimise the process of inpatient medication therapy to prevent inappropriate medication use and thus promote patient safety.Methods and analysisThe intervention will be evaluated in a prospective, cluster-randomised controlled trial using a stepped-wedge design. The study will be conducted in 12 hospitals across Germany over a total period of 33 months. Patients will be treated according to the group status of the hospital and receive either standard care or the Transsektorale Optimierung der Patientensicherheit or trans-sectoral optimisation of patient safety intervention. The primary outcome is the combined endpoint of all-cause mortality and all-cause hospitalisation. Secondary endpoints are, for example, inappropriate prescriptions, utilisation of different health services, cost-effectiveness, as well as patient-reported outcome measures. Parameters describing the attitudes of patients and healthcare professionals towards the intervention and organisational change processes will be collected as part of the process evaluation. The primary endpoint will be evaluated using hospital and outpatient claims data from participating statutory health insurances at the population level. There are multiple secondary endpoints with data linkage of primary and secondary data at study participant level. Statistical analysis will make use of (generalised) linear mixed models or generalised estimating equations, taking account of independent covariables. All data analyses of the process evaluation will be descriptive and explorative.Ethics and disseminationData collection, storage and evaluation meet all applicable data protection regulations. The trial has been approved by the Ethics Committees of the University of Wuppertal and the Medical Association of Saarland, Germany. Results will be disseminated through workshops, peer-reviewed publications and local and international conferences.Trial registration numberDRKS00025485.

Objectives This longitudinal population study aimed to investigate if maternal depression at different time points during the perinatal period impacts children’s social-emotional development at 2 years of age. Methods Participants were women (n = 1235) who gave birth at Akershus University Hospital in Norway. Maternal depressive symptoms were assessed by using the Edinburgh Postnatal Depression Scale at pregnancy week 32 and at 8 weeks and 2 years postpartum, whereas children’s social-emotional development at the age of 2 years was assessed by using the Ages and Stages Questionnaire: Social-Emotional. Bi- and multivariate logistic regression analyses were conducted to examine the linkage between maternal perinatal depression and children’s early social-emotional development. Results Multivariate analyses showed that social-emotional problems in the child 2 years after birth were strongly associated with maternal depression at pregnancy week 32 (adjusted odds ratio (aOR) 3.4; 95 % CI 1.4–8.0), depression at 8 weeks postpartum (aOR 3.8; 95 % CI 1.7–8.6), and with depression at both time points (aOR 3.7; 95 % CI 1.5–10.1). Conclusion Findings indicate pre- and postnatal depression each bears an independent, adverse impact on children’s social-emotional development.

Introduction Anxiety in women is highly prevalent during pregnancy and in the postnatal period. Anxiety disorders in mothers have been linked to adverse outcomes in their children’s development. However, large-scale prospective studies on this issue, covering both the prenatal and postnatal period with follow-up periods beyond the first year of life are scarce. Method In this prospective cohort study, data gathered from 1336 Norwegian women and their children were used. Maternal anxiety symptoms were measured at gestation week 17–19 and 32, as well as 8 weeks postpartum using the Symptom Check List. Child development problems were assessed at 2 years postpartum using the Ages & Stages Questionnaire: Social-Emotional. Logistic regressions were conducted to examine the association between maternal prenatal, postnatal, and perinatal anxiety and the risk of social-emotional development problems in 2-year-old children. Results Of all women, 8.2% experienced prenatal anxiety, 4.0% had postnatal anxiety, and 4.4% reported perinatal anxiety (i.e., anxiety in both the prenatal and postnatal period). 5.6% of the 2-year-olds showed problems in their social-emotional behavior. Child development problems were associated with maternal prenatal anxiety (Odds Ratio [OR] = 2.48, 95% CI 1.55–4.92), postnatal anxiety (OR 3.32, 95% CI 1.43–7.74), and anxiety both in the prenatal and postnatal period (OR 3.98, 95% CI 1.85–8.56). Adjusted for confounders, maternal anxiety continued to be a significant predictor of adverse child social-emotional development (postnatal anxiety: OR 2.46, 95% CI 1.01–5.97; perinatal anxiety: OR 2.40, 95% CI 1.03–5.59). Discussion Maternal postnatal anxiety and anxiety both during and after pregnancy are unique substantial predictors for problems in a 2-year-old’s social-emotional development, even when controlled for confounders.

•Varicella breakthrough disease is rare in Germany, particularly if vaccinated twice.•Suspected clinical varicella in vaccinated cases requires laboratory confirmation.•Confirmation rate of varicella is lower after two than after one vaccine dose(s). Accompanying varicella vaccination in children in Germany recommended with one (2004) and two (2009) doses, sentinel surveillance of varicella with a sample (n∼900) of private physicians was established in 2005. Physicians reported monthly aggregated data on all varicella cases and case-based on vaccinated patients, of whom skin lesion samples were laboratory investigated to identify varicella-zoster virus (VZV). We analyzed the impact of vaccination frequency on the number of cases and on laboratory results within the sentinel. Swabs were obtained with a Teflon tip and sent together with a case-based questionnaire to the reference laboratory. VZV wild-type and vaccine-type was identified by polymerase chain-reaction (PCR) and pyrosequencing methods. Case-based data and laboratory results were analyzed descriptively. From April 2005 to March 2014, of all monthly reported cases (n=111,456) 4789 were vaccinated and eligible for further analysis. No differences were found between laboratory investigated and not investigated cases (1017 vs. 3772) except that the proportion of cases vaccinated twice was higher in lab-cases (29.4% vs. 16.1%). PCR remained negative in 69.6% (197/283) of breakthrough-cases vaccinated twice, in comparison to 22.7% (147/649) breakthrough-cases vaccinated once. VZV was confirmed in 500 (81) patients with breakthrough varicella after one (two) vaccination(s); identification of VZV wild-type, vaccine-type, or no further differentiation was possible in 485 (72), 5 (6), and 10 (3) cases, respectively. Varicella breakthrough disease is rare in Germany and suspected clinical cases require laboratory confirmation. The lower confirmation rate of VZV after two vaccine doses suggests a better protection compared to one dose.