BMJ open
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An initial retrospective study suggested that tranexamic acid (TXA) administration increased the incidence of seizures in paediatric patients undergoing cardiac surgery. However, the efficacy of TXA in paediatric cardiac surgery remains unclear owing to the small sample sizes of the studies. Therefore, this study will investigate the efficacy and safety of TXA in paediatric patients undergoing cardiac surgery. We hypothesised that TXA may increase the incidence of postoperative seizures with no effect on postoperative allogeneic transfusion in paediatric patients undergoing cardiac surgery. The pragmatic study will provide important implications for paediatric cardiac surgery. ⋯ This study was approved by the institutional review board of Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (No 20191195). Written informed consent will be obtained from the parents/legal guardian of each patient because all participants will be <18 years of age. The results of the trial will be published in an international peer-reviewed journal.
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The purpose of this systematic review was to critically appraise and synthesise the psychometric properties of Global Rating of Change (GROC) scales for assessment of patients with neck pain. ⋯ CRD42018117874.
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To compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014-2016. ⋯ There was general agreement in EMA / FDA conditional approvals. FDA used expedited pathways and orphan designation more often than EMA, suggesting stricter EMA criteria or definitions for these designations or less flexible processes. Despite consistency in submitted indications, there was lack of concordance in approved indications, which should be further investigated. FDA review times are faster because of a wider range of expedited pathways and the two-step EMA process; this may change with recent revisions to EMA accelerated assessment guidelines and the launch of Priority Medicines.
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To determine the prevalence of burnout in doctors practising obstetrics and gynaecology, and assess the association with defensive medical practice and self-reported well-being. ⋯ High levels of burnout were observed in obstetricians and gynaecologists and particularly among trainees. Burnout was associated with both increased defensive medical practice and worse doctor well-being. These findings have implications for the well-being and retention of doctors as well as the quality of patient care, and may help to inform the content of future interventions aimed at preventing burnout and improving patient safety.
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To evaluate the cost-effectiveness of the 9-valent human papillomavirus (HPV) vaccine for the prevention of cervical cancer in China. ⋯ At the current price, the 9-valent HPV vaccine is not cost-effective compared with the quadrivalent and the bivalent vaccines for young girls in China who had not been previously infected with HPV. Policymakers and clinicians should keep potential vaccine recipients informed about the economic profile of the 9-valent vaccine and carefully consider expanding its use in China at the current price.