16 research outputs found

    Azithromycin therapy for prevention of chronic lung disease of prematurity (AZTEC): a multicentre, double-blind, randomised, placebo-controlled trial

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    Background Systematic reviews have reported conflicting evidence on whether macrolide antibiotics reduce rates of chronic lung disease of prematurity (CLD) in at-risk preterm infants born at less than 30 weeks’ gestation, including in those colonised with pulmonary Ureaplasma spp. Since an adequately powered trial has been lacking, we aimed to assess if the macrolide azithromycin improved survival without the development of physiologically defined moderate or severe CLD in preterm infants. Methods AZTEC was a multicentre, double-blind, randomised, placebo-controlled trial conducted in 28 tertiary neonatal intensive care units in the UK. Infants were eligible if they were born at less than 30 weeks’ gestation and had received at least 2 h of either non-invasive (continuous positive airway pressure or humidified high flow nasal cannula therapy) or invasive respiratory support (via endotracheal tube) within 72 h of birth. Eligible infants were randomly allocated in a 1:1 ratio using random permuted blocks of four to receive either intravenous azithromycin at 20 mg/kg per day for 3 days followed by 10 mg/kg for 7 days, or to placebo. Allocation was stratified by centre and gestational age at birth (<28 weeks vs ≥28 weeks). Azithromycin and placebo vials were encased in tamper-evident custom cardboard cartons to ensure masking for clinicians, parents, and the research team. The primary outcome was survival without development of physiologically defined moderate or severe CLD at 36 weeks’ postmenstrual age. Outcomes and safety were analysed on an intention-to-treat basis (all randomly allocated infants, regardless of any post-randomisation events). The study was registered with ISRCRN (11650227) and is closed. Findings Infants were recruited between Oct 9, 2019, and March 22, 2022. 799 (53·1%) of 1505 eligible infants underwent random allocation; three infants were withdrawn, including consent to use their data, leaving 796 infants for analysis. Survival without moderate or severe CLD occurred in 166 (42%) of 394 infants in the intervention group and 179 (45%) of 402 in the placebo group (three-level adjusted OR [aOR] 0·84, 95% CI 0·55–1·29, p=0·43). Pulmonary Ureaplasma spp colonisation did not influence treatment effect. Overall, seven serious adverse events were reported for the azithromycin group (five graded as severe, two as moderate), and six serious adverse events were reported in the placebo group (two severe, two moderate, and two mild), as assessed by the local principal investigators. Interpretation Since prophylactic use of azithromycin did not improve survival without development of physiologically-defined CLD, regardless of Ureaplasma spp colonisation, it cannot be recommended in clinical practice

    An optimal trauma-informed pathway for PTSD, complex PTSD and other mental health and psychosocial impacts of trauma in prisons: an expert consensus statement

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    People in prisons have high levels of trauma exposure throughout their lives. Presentations are often complex, with a high prevalence of PTSD and CPTSD and other mental health comorbidities. Prisons themselves can be stressful and traumatising environments. There are challenges in the delivery of effective treatments for PTSD and CPTSD. There is a need for the development of effective clinical pathways for these conditions that are embedded within trauma-informed organisational approaches. Responding to this need, this report is the result of a multidisciplinary expert consensus meeting and review of the research literature on PTSD, CPTSD, associated comorbidities and optimal approaches to trauma-informed practice. The group consisted of 24 expert representatives from psychology, psychiatry, healthcare, academia, social care and Welsh Government. The meeting commenced with presentations on various aspects of the clinical pathway for PTSD and complex PTSD in prisons, and of applications of trauma-informed practice within prisons. Small sub-groups then provided practical recommendations and solutions relevant to their assigned topic. Findings were presented to all meeting attendees for another round of discussion and debate, until consensus was reached. The resulting recommendations provide guidance to improve identification, treatment and support for people living in prison who have experienced trauma

    Subsequent female breast cancer risk associated with anthracycline chemotherapy for childhood cancer

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    Anthracycline-based chemotherapy is associated with increased subsequent breast cancer (SBC) risk in female childhood cancer survivors, but the current evidence is insufficient to support early breast cancer screening recommendations for survivors treated with anthracyclines. In this study, we pooled individual patient data of 17,903 survivors from six well-established studies, of whom 782 (4.4%) developed a SBC, and analyzed dose-dependent effects of individual anthracycline agents on developing SBC and interactions with chest radiotherapy. A dose-dependent increased SBC risk was seen for doxorubicin (hazard ratio (HR) per 100 mg m−2: 1.24, 95% confidence interval (CI): 1.18–1.31), with more than twofold increased risk for survivors treated with ≥200 mg m−2 cumulative doxorubicin dose versus no doxorubicin (HR: 2.50 for 200–299 mg m−2, HR: 2.33 for 300–399 mg m−2 and HR: 2.78 for ≥400 mg m−2). For daunorubicin, the associations were not statistically significant. Epirubicin was associated with increased SBC risk (yes/no, HR: 3.25, 95% CI: 1.59–6.63). For patients treated with or without chest irradiation, HRs per 100 mg m−2 of doxorubicin were 1.11 (95% CI: 1.02–1.21) and 1.26 (95% CI: 1.17–1.36), respectively. Our findings support that early initiation of SBC surveillance may be reasonable for survivors who received ≥200 mg m−2 cumulative doxorubicin dose and should be considered in SBC surveillance guidelines for survivors and future treatment protocols

    Sketching women in court: The visual construction of co-accused women in court drawings

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    This paper explores the visual construction and representation of co-accused women offenders in court drawings. It utilises three case studies of female co-defendants who appeared in the England and Wales court system between 2003 and 2013. In doing so this paper falls into three parts. The first part considers the emergence of the sub-discipline, visual criminology and examines what is known about the visual representation of female offenders. The second part presents the findings of an empirical investigation, which involved engaging in a critical, reflexive visual analysis of a selection of court drawings of three female co-offenders. The third part discusses the ways in which the court artists' interpretation, the conventions of court sketching, and motifs of female offenders as secondary actors, drew on existing myths and prejudices by representing the women as listening, remorseless ‘others’

    Use of antidiabetic agents and the risk of pancreatic cancer : a case-control analysis

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    The objective of this study was to explore the association between use of metformin or other antidiabetic drugs, diabetes, and the risk of pancreatic cancer.; We conducted a case-control study using the UK-based General Practice Research Database (GPRD). Cases had a first-time diagnosis of pancreatic cancer, and six controls per case were matched on age, sex, calendar time, general practice, and number of years of active history in the GPRD before the index date. Results were further adjusted in multivariate logistic regression analyses for potential confounders such as body mass index, smoking, alcohol consumption, and diabetes duration.; In all, 2,763 case patients with a recorded diagnosis of pancreatic cancer were identified. Mean age ± s.d. was 69.5 ± 11.0 years. Long-term use (≥ 30 prescriptions) of metformin was not associated with a materially altered risk of pancreatic cancer (adjusted odds ratio (adj. OR): 0.87, 95% confidence interval (CI): 0.59-1.29), but there was a suggestion of effect modification by gender, as long-term use of metformin was linked to a decreased risk in women (adj. OR: 0.43, 95% CI: 0.23-0.80). Both use of sulfonylureas (≥ 30 prescriptions, adj. OR: 1.90, 95% CI: 1.32-2.74) and of insulin (≥ 40 prescriptions, adj. OR: 2.29, 95% CI: 1.34-3.92) were associated with an increased risk of pancreatic cancer.; Use of metformin was associated with a decreased risk of pancreatic cancer in women only, whereas use of sulfonylureas and of insulin was associated with an increased risk of pancreatic cancer
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