Intrapartum antibiotics for prolonged rupture of membranes at term to prevent Group B Streptococcal sepsis.

The timely administration of intrapartum antibiotic prophylaxis (IAP) to eligible pregnant mothers reduces the risk of early onset Group B Streptococcus (GBS) neonatal sepsis. The incidence of neonatal GBS sepsis is increasing, in spite of national guidelines for its prevention. This retrospective cohort study was undertaken to assess the incidence of culture-proven GBS sepsis before and after a change of practice on intrapartum management of GBS sepsis in babies born at Sunderland Royal Hospital between January 1 2008 and December 31 2017. The data regarding the risk factors, the intrapartum antibiotic prophylaxis and the outcomes of the babies were collected. Twenty-nine cases were identified and presented in two epochs-before and after changing guidelines for intrapartum management. There was a statistically significant reduction in early onset sepsis rates and no difference in late-onset sepsis rates. The prolonged rupture of membranes is a significant risk factor at any gestation. Impact statement What is already known on this subject? Appropriate intrapartum administration of antibiotics in mothers reduces 80% of early-onset GBS infections. In the United Kingdom, IAP is given based on risk factors, which fail to accurately identify and treat the woman who harbours GBS in the birth canal in labour and the incidence of GBS neonatal sepsis is increasing. The national guideline on the prevention of GBS sepsis is not consistent and is open to interpretation. What do the results of this study add? This study highlights prolonged rupture of membranes as a significant risk factor at any gestation and there were missed opportunities to prevent GBS sepsis in term babies with the prolonged rupture of membranes. This study also highlights that it is possible to reduce the neonatal GBS sepsis burden by adhering to guidelines and administering timely intrapartum antibiotics. What are the implications of these findings for clinical practice and/or further research? The timely administration of IAP to all eligible women is possible if the national guidelines are consistent and interpreted correctly. Our national guideline on the prolonged rupture of membranes at term is not clear and is interpreted differently. If IAP is provided in all those with risk factors irrespective of gestation, this would involve additional costs to the NHS; but in the long term, it will benefit as it reduces morbidity.

Feasibility of Using Gluconolactone, Trehalose and Hydroxy-Propyl Gamma Cyclodextrin to Enhance Bendroflumethiazide Dissolution Using Lyophilisation and Physical Mixing Techniques.

PURPOSE: Hydrophobic drugs are facing a major challenge in dissolution rate enhancement and solubility in aqueous solutions; therefore, a variety of methods have been used to improve dissolution rate and/or solubility of bendroflumethiazide as a model hydrophobic drug. METHODS: In this study, two main methods (physical mixing and lyophilisation) were used with gluconolactone, hydroxyl propyl γ-ccyclodextrin, and trehalose to explore this challenge. Bendroflumethiazide, practically insoluble in water, was mixed with one of the three excipients gluconolactone, hydroxyl propyl γ-cyclodextrin, and trehalose in three different ratios 1:1, 1:2, 1:5. To the best of our knowledge, the dissolution of the drug has not been previously enhanced by using either these methods or any of the used excipients. Samples containing drug and each of the excipients were characterized via dissolution testing, Fourier Transform infra-red spectroscopy, differential scanning calorimetry, and scanning electron microscopy. RESULTS: The used methods showed a significant enhancement in dug dissolution rate; physical mixing significantly, p < 0.05, increased the percentage of the drug released with time; for example, bendroflumethiazide dissolution in distilled water was improved from less than 20% to 99.79% within 90 min for physically mixed drug-cyclodextrin 1:5. The lyophilisation process was enhanced and the drug dissolution rate and the highest drug dissolution was achieved for (drug-gluconolactone 1:1) with 98.98% drug release within 90 min. CONCLUSIONS: the physical mixing and freeze drying processes significantly increased the percentage of drug release with time.

Prospective pilots of routine data capture by paediatricians in clinics and validation of the Disabilities Complexity Scale.

AIMS: To pilot prospective data collection by paediatricians at the point of care across England using a defined terminology set; demonstrate feasibility of data collection and utility of data outputs; and confirm that counting the number of needs per child is valid for quantifying complexity. METHOD: Paediatricians in 16 hospital and community settings collected and anonymized data. Participants completed a survey regarding the process. Data were analysed using R version 3.1.2. RESULTS: Overall, 8117 needs captured from 1224 consultations were recorded. Sixteen clinicians responded positively about the process and utility of data collection. The sum of needs varied significantly (p<0.01) by level of gross motor function ascertained using the Gross Motor Function Classification System for children with cerebral palsy; epilepsy severity as defined by level of expertise required to manage it; and by severity of intellectual disability. INTERPRETATION: Prospective data collection at the point of clinical care proved possible without disrupting clinics, even for those with the most complex needs, and took the least time when done electronically. Counting the number of needs was easy to do, and quantified complexity in a way that informed clinical care for individuals and related directly to validated scales of functioning. Data outputs could inform more appropriate design and commissioning of quality services.

Quantifying multifaceted needs captured at the point of care. Development of a Disabilities Terminology Set and Disabilities Complexity Scale.

AIMS: To develop a Disabilities Terminology Set and quantify the multifaceted needs of disabled children and their families in a district disability clinic population. METHOD: Data from structured electronic clinic letters of children attending paediatric disability clinics from June 2007 to May 2012 in Sunderland, north-east England collected at the point of clinical care were analysed to determine appropriate terms for consistent recording of each need and issue. Terms were collated to count the number of needs per child. RESULTS: A Systemized Nomenclature of Medicine - Clinical Terms subset of 296 terms was identified and published, and 8392 consultations for 1999 children were reviewed. The required number of clinic appointments correlated strongly with the number of needs identified. Children with intellectual disabilities in addition to cerebral palsy and epilepsy had more than double the number of conditions, technology dependencies, and family-reported issues than those without. Disabled children who subsequently died had the highest burden of needs (p=0.007). INTERPRETATION: Detailed data about needs generated outputs useful for local care pathway development and service planning. Sufficient evidence was provided for successful business cases leading to the appointment of additional paediatric disability consultants. Counting numbers of needs and issues quantifies complexity in a straightforward way. This could underpin needs-based commissioning of services.

Disclosure and adverse effects of complementary and alternative medicine used by hospitalized patients in the North East of England.

OBJECTIVE: This study aimed to investigate the prevalence, disclosure and adverse effects of complementary and alternative medicine (CAM) use in hospitalised patients, and to explore the associations between patients' perceived side-effects and relevant factors. METHODS: Patients who were admitted to a district general hospital and met the eligibility criteria were interviewed using a semi-structured questionnaire. Their medications and pertinent details were verified from the medical notes. All quantitative and qualitative data were collated and analysed. A chi-squared test was performed to test the associations of the perceived CAM side-effects with the significance level determined at α=0.05. RESULTS: A total of 240 in-patients completed the study. They were mostly white British (98.8%). The prevalence of CAM use within two years was 74.6% and one month 37.9%. Only 19 of 91 patients (20.9%) using CAM within one month disclosed their current CAM applications. Nearly half of patients (45.8%) who used CAM within two years experienced various CAM side-effects that tended to resolve after discontinuation. Slightly more than half (57.6%) perceived CAM side-effects and their perceptions were significantly associated with gender (P=0.048) and consideration for future CAM use (P=0.033). Potential interactions between herbal remedies/dietary supplements and prescribed drugs, such as garlic with lisinopril or aspirin, were assessed in 82 patients (45.8%). CONCLUSIONS: Most in-patients used CAM and experienced some adverse effects. The disclosure of CAM use and its adverse outcomes should be encouraged by healthcare professionals.