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The aetiology of bacterial vaginosis (BV), a biofilm-associated vaginal infection, remains unknown. Epidemiologic data suggest that it is sexually transmitted. BV is characterised by loss of lactic acid-producing lactobacilli and an increase in facultative and strict anaerobic bacteria. Gardnerella spp are present in 95%–100% of cases; Gardnerella vaginalis has been found to be more virulent than other BV-associated bacteria (BVAB) in vitro. However, G. vaginalis is found in women with normal vaginal microbiota and colonisation is not sufficient for BV development. We hypothesise that Gardnerella spp initiate BV biofilm formation, but incident BV (iBV) requires incorporation of other key BVAB (ie, Prevotella bivia, Fannyhessea vaginae) into the biofilm that alter the transcriptome of the polymicrobial consortium. This study will investigate the sequence of microbiologic events preceding iBV.
This study will enrol 150 women aged 18–45 years with normal vaginal microbiota and no sexually transmitted infections at a sexual health research clinic in Birmingham, Alabama. Women will self-collect twice daily vaginal specimens up to 60 days. A combination of 16S rRNA gene sequencing, qPCR for Gardnerella spp, P. bivia and F. vaginae, and broad range 16S rRNA gene qPCR will be performed on twice daily vaginal specimens from women with iBV (Nugent score 7–10 on at least 2 consecutive days) and controls (with comparable age, race, contraceptive method and menstrual cycle days) maintaining normal vaginal microbiota to investigate changes in the vaginal microbiota over time for women with iBV. Participants will complete daily diaries on multiple factors including sexual activity.
This protocol is approved by the University of Alabama at Birmingham Institutional Review Board (IRB-300004547) and written informed consent will be obtained from all participants. Findings will be presented at scientific conferences and published in peer-reviewed journals as well as disseminated to providers and patients in communities of interest.
To investigate whether intravenous immunoglobulin (IVIG) improves neurological outcomes in children with encephalitis when administered early in the illness.
Phase 3b multicentre, double-blind, randomised placebo-controlled trial.
Twenty-one hospitals in the UK.
Children aged 6 months to 16 years with a diagnosis of acute or subacute encephalitis, with a planned sample size of 308.
Two doses (1 g/kg/dose) of either IVIG or matching placebo given 24–36 hours apart, in addition to standard treatment.
The primary outcome was a ‘good recovery’ at 12 months after randomisation, defined as a score of≤2 on the Paediatric Glasgow Outcome Score Extended.
The secondary outcomes were clinical, neurological, neuroimaging and neuropsychological results, identification of the proportion of children with immune-mediated encephalitis, and IVIG safety data.
18 participants were recruited from 12 hospitals and randomised to receive either IVIG (n=10) or placebo (n=8) between 23 December 2015 and 26 September 2017. The study was terminated early following withdrawal of funding due to slower than anticipated recruitment, and therefore did not reach the predetermined sample size required to achieve the primary study objective; thus, the results are descriptive. At 12 months after randomisation, 9 of the 18 participants (IVIG n=5/10 (50%), placebo n=4/8 (50%)) made a good recovery and 5 participants (IVIG n=3/10 (30%), placebo n=2/8 (25%)) made a poor recovery. Three participants (IVIG n=1/10 (10%), placebo n=2/8 (25%)) had a new diagnosis of epilepsy during the study period. Two participants were found to have specific autoantibodies associated with autoimmune encephalitis. No serious adverse events were reported in participants receiving IVIG.
The IgNiTE (ImmunoglobuliN in the Treatment of Encephalitis) study findings support existing evidence of poor neurological outcomes in children with encephalitis. However, the study was halted prematurely and was therefore underpowered to evaluate the effect of early IVIG treatment compared with placebo in childhood encephalitis.
Clinical Trials.gov NCT02308982; ICRCTN registry
To explore whether sleep deprivation contributes to medication errors in registered nurses (RNs).
Sleep deprivation is a potential issue for RNs, particularly those who work shifts. Sleep deprivation has been found to have a negative impact on numerous cognitive processes. Nurses administer several medications to patients a day, potentially while sleep deprived—anecdotal reports suggest that this could result in an increased risk of error occurring.
A scoping review was conducted using the Prisma-ScR extension framework to explore what is known about the effect of RNs' sleep deprivation on medication administration errors.
A search of databases generated 171 results. When inclusion and exclusion criteria were applied, 18 empirical studies were analysed. Studies included retrospective analysis of errors, surveys of perceptions of causes and observational studies.
Data indicated that RNs consider fatigue, which may be caused by sleep deprivation, to be a contributing factor to medication errors. The search only identified three observer studies, which provided conflicting results as to whether lack of sleep contributes to the error rate. Of the numerous tools used to measure sleep, the Pittsburgh Sleep Quality Index was the most frequently used.
Although RNs anecdotally consider a lack of sleep potentially contributes to medication errors, there is insufficient research to provide robust evidence to confirm this assumption.
Patient or public contributions were not required for this scoping review.
Sleep deprivation is a potential issue for nurses, especially those who work shifts. Poor sleep impacts cognitive processes that potentially could increase errors. Nurses should be aware of the impact sleep may have on patient safety.
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