To evaluate the need for, and the development and utility of, pen-and-paper (Modified) Early Warning Scoring (MEWS/EWS) systems for adult inpatients outside critical care and emergency departments, by reviewing published literature. Serious adverse events can be prevented by recognizing and responding to early signs of clinical and physiological deterioration. Of 534 papers reporting MEWS/EWS systems for adult inpatients identified, 14 contained useable data on development and utility of MEWS/EWS systems. Systems without aggregate weighted scores were excluded. MEWS/EWS systems facilitate recognition of abnormal physiological parameters in deteriorating patients, but have limitations. There is no single validated scoring tool across diagnoses. Evidence of prospective validation of MEWS/EWS systems is limited; neither is implementation based on clinical trials. There is no evidence that implementation of Westernized MEWS/EWS systems is appropriate in resource-poor locations. Better monitoring implies better care, but there is a paucity of data on the validation, implementation, evaluation and clinical testing of vital signs' monitoring systems in general wards. Recording vital signs is not enough. Patient safety continues to depend on nurses' clinical judgment of deterioration. Resources are needed to validate and evaluate MEWS/EWS systems in context.

Objective: To explore the prescribing patterns of selective serotonin reuptake inhibitors (SSRIs) before, during and after pregnancy in six European population‐based databases.Design: Descriptive drug utilisation study.Setting: Six electronic healthcare databases in Denmark, the Netherlands, Italy (Emilia Romagna/Tuscany), Wales and the rest of the UK.Population: All women with a pregnancy ending in a live or stillbirth starting and ending between 2004 and 2010.Methods: A common protocol was implemented across databases to identify SSRI prescriptions issued (UK) or dispensed (non‐UK) in the year before, during or in the year following pregnancy.Main outcome measures: The percentage of deliveries in which the woman received an SSRI prescription in the year before, during or in the year following pregnancy. We also compared the choice of SSRIs and changes in prescribing over the study period.Results: In total, 721 632 women and 862 943 deliveries were identified. In the year preceding pregnancy, the prevalence of SSRI prescribing was highest in Wales [9.6%; 95% confidence interval (CI₉₅), 9.4–9.8%] and lowest in Emilia Romagna (3.3%; CI₉₅, 3.2–3.4%). During pregnancy, SSRI prescribing had dropped to between 1.2% (CI₉₅, 1.1–1.3%) in Emilia Romagna and 4.5% (CI₉₅, 4.3–4.6%) in Wales. The higher UK pre‐pregnancy prescribing rates resulted in higher first trimester exposures. After pregnancy, SSRI prescribing increased most rapidly in the UK. Paroxetine was more commonly prescribed in the Netherlands and Italian regions than in Denmark and the UK.Conclusions: The higher SSRI prescribing rates in the UK, compared with other European regions, raise questions about differences in the prevalence and severity of depression and its management in pregnancy across Europe.

The vulnerability of clinical trials to volunteer bias is under-reported. Volunteer bias is systematic error due to differences between those who choose to participate in studies and those who do not. This paper extends the applications of the concept of volunteer bias by using data from a trial of probiotic supplementation for childhood atopy in healthy dyads to explore 1) differences between a) trial participants and aggregated data from publicly available databases b) participants and non-participants as the trial progressed 2) impact on trial findings of weighting data according to deprivation (Townsend) fifths in the sample and target populations. 1) a) Recruits (n = 454) were less deprived than the target population, matched for area of residence and delivery dates (n = 6,893) (mean [SD] deprivation scores 0.09[4.21] and 0.79[4.08], t = 3.44, df = 511, p<0.001). b) i)As the trial progressed, representation of the most deprived decreased. These participants and smokers were less likely to be retained at 6 months (n = 430[95%]) (OR 0.29,0.13–0.67 and 0.20,0.09–0.46), and 2 years (n = 380[84%]) (aOR 0.68,0.50–0.93 and 0.55,0.28–1.09), and consent to infant blood sample donation (n = 220[48%]) (aOR 0.72,0.57–0.92 and 0.43,0.22–0.83). ii)Mothers interested in probiotics or research or reporting infants’ adverse events or rashes were more likely to attend research clinics and consent to skin-prick testing. Mothers participating to help children were more likely to consent to infant blood sample donation. 2) In one trial outcome, atopic eczema, the intervention had a positive effect only in the over-represented, least deprived group. Here, data weighting attenuated risk reduction from 6.9%(0.9–13.1%) to 4.6%(−1.4–+10.5%), and OR from 0.40(0.18–0.91) to 0.56(0.26–1.21). Other findings were unchanged. Potential for volunteer bias intensified during the trial, due to non-participation of the most deprived and smokers. However, these were not the only predictors of non-participation. Data weighting quantified volunteer bias and modified one important trial outcome. This randomised, double blind, parallel group, placebo controlled trial is registered with the International Standard Randomised Controlled Trials Register, Number (ISRCTN) 26287422. Registered title: Probiotics in the prevention of atopy in infants and children.

Lactic acid bacteria and bifidobacteria are increasingly being administered to pregnant women and infants with the intention of improving health. Alt