Haemolymphatic cancer among children

alkiviadis.1961 shared this article with you from Inoreader Haemolymphatic cancer among children in Sardinia, Italy: 1974-2003 incidence Via BMJ Open Current Issue Objectives To explore the time trend and geographical distribution of childhood leukaemia incidence over the territory of the Italian region of Sardinia. Setting All hospitals departments, diagnostic centres and social security agencies in Sardinia were regularly screened in 1974–2003 to identify, register and review the diagnoses of incident cases of haematological malignancies (HM). Participants The whole child population aged 0–14 resident in Sardinia. Primary and secondary outcome measures Incidence and time trend of childhood HM and childhood acute lymphoblastic leukaemia (ALL) over the study period, and use of Bayesian methods to plot the probability of areas with excess incidence on the regional map. Results Overall, 675 HM cases, including 378 ALL cases, occurred among children aged 0–14 years resident in Sardinia in 1974–2003, with an incidence rate of 6.97x10-5 (95% CI 6.47 to 7.51) and 3.85x10-5 (95% CI 3.48 to 4.26), respectively. Incidence of HM and ALL showed an upward trend along the study period especially among females. Three communes out of the 356 existing in 1974, namely Ittiri, Villa San Pietro and Carbonia, stand out as areas with excess incidence of HM and ALL in particular and another, Carloforte, for ALL only. Conclusions Our results might serve as convincing arguments for extending the coverage of routine cancer registration over the whole Sardinian population, while prompting further research on the genetic and environmental determinants in the areas at risk. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD)

alkiviadis.1961 shared this article with you from Inoreader Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial Via BMJ Open Current Issue Introduction Pancreaticoduodenectomy (PD) is a major gastroenterological surgery that results in a substantial amount of blood loss. Several studies have demonstrated that major blood loss during PD is associated with both short-term and long-term poor outcomes. Administration of perioperative tranexamic acid (TXA) has been reported to reduce intraoperative blood loss in various surgeries, including cardiovascular surgery and orthopaedic surgery. Nevertheless, the effect of perioperative TXA use in patients undergoing PD has not been investigated. This study aims to investigate the effect of TXA on blood loss during PD. Methods and analysis A multicentre (six hospitals), randomised, blind (patient-blinded, surgeon-blinded, anaesthesiologist-blinded, monitor-blinded), placebo-controlled trial of TXA during PD was started in September 2019. Patients undergoing PD for biliary, duodenal or pancreatic diseases are randomly assigned to the TXA or placebo group. The stratification factors are the institutions and preoperative clinical diagnosis. Before skin incision, the participants in TXA group are administrated 1 g TXA as a loading infusion followed by a maintenance infusion of 125 mg/hour TXA until the end of surgery or 8 hours from the incision. Participants in the placebo group are administrated the same volume of saline that is indistinguishable from the TXA. The primary outcome is blood loss during PD. The secondary outcomes are intraoperative and postoperative (up to day 2) blood transfusions, operation time, anaesthesia time, postoperative laboratory variables, length of hospital stay, in-hospital and 90-day morta lity and postoperative complications occurring within 28 days of surgery or requiring readmission. To date, 115 patients of a planned 220 have been enrolled in the study. Ethics and dissemination This protocol was approved by the Nagoya University Clinical Research Review Board and is registered with Japan Registry of Clinical Trials on 15 August 2019. The results of this trial will be disseminated through peer-reviewed journals. Trial registration number jRCTs041190062. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Impact of SARS-CoV-2 (COVID-19) on pregnancy

alkiviadis.1961 shared this article with you from Inoreader Impact of SARS-CoV-2 (COVID-19) on pregnancy: a systematic review and meta-analysis protocol Via BMJ Open Current Issue Introduction The COVID-19 pandemic, caused by the SARS-CoV-2 virus, has been growing at an accelerating rate, and has become a public health emergency. Pregnant women and their fetuses are susceptible to viral infection, and outcomes in this population need to be investigated. Methods and analysis PubMed, Web of Science, Embase, CINAHAL, Latin American and Caribbean Health Sciences Literature, clinicaltrials.gov, SCOPUS, Google Scholar and Cochrane Central Controlled Trials Registry will be searched for observational studies (cohort and control cases) published from December 2019 to present. This systematic review and meta-analysis will include studies of pregnant women at any gestational stage diagnosed with COVID-19. The primary outcomes will be maternal and foetal morbidity and mortality. Three independent reviewers will select the studies and extract data from the original publications. The risk of bias will be assessed using the Newcastle-Ottawa Scale for observational studies. To evaluate the strength of evidence from the included data, we will use Grading of Recommendation Assessment, Development, and Evaluation method. Data synthesis will be performed using Review Manager software V.5.2.3. To assess heterogeneity, we will compute the I2 statistics. Additi onally, a quantitative synthesis will be performed if the included studies are sufficiently homogenous. Ethics and dissemination This study will be a review of the published data, and thus it is not necessary to obtain ethical approval. The findings of this systematic review will be published in a peer-reviewed journal. PROSPERO registration number PROSPERO 2020: CRD42020181519. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

End-stage renal disease as a risk factor for epiglottitis

alkiviadis.1961 shared this article with you from Inoreader End-stage renal disease as a risk factor for epiglottitis: a population-based cohort study in Taiwan Via BMJ Open Current Issue Objectives Patients with uremia are prone to infection; however, end-stage renal disease (ESRD) as a risk factor for acute epiglottitis warrants study. We investigated the risk of severe epiglottitis requiring hospitalisation in patients with ESRD. Setting We conducted a retrospective matched cohort study by using the claims data of Taiwan's National Health Insurance Research Database. Participants We identified an ESRD cohort with 87 908 patients newly diagnosed in 2000–2013 and underwent dialysis. The non-ESRD cohort comprised patients who had not received a diagnosis of ESRD, and they were matches to the ESRD cohort (1:1) by sex, age, residence urbanisation level, monthly income, and diabetes and hypertension status. Primary and secondary outcome measures The cumulative incidence of epiglottitis at the end of 2013 was analysed with Kaplan-Meier methods and log-rank tests. The HR of epiglottitis was calculated using the Cox proportional hazards model after adjustment for confounding factors. Results The overall epiglottitis incidence rate was 94% greater in the ESRD cohort than in the non-ESRD cohort (10.3 vs 5.3 cases per 100 000 person-years, p=0.002), with an adjusted HR of 1.89 (95% CI: 1.23 to 2.91, p=0.004). In the log-rank analysis, compared with the non-ESRD group, the epiglottitis cumulative incidence was significantly higher in the ESRD group (p=0.003). Epiglottitis did not exhibit an association with higher rates of airway interventions, intensive care unit admissions or longer hospitalisation in patients with ESRD than in controls. Conclusions This nationwide matched cohort study indicated that ESRD patients should be monitored for the risk of severe epiglottitis requiring hospitalisation. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Assessing the safety and feasibility of neoadjuvant hormone and radiation therapy followed by robot-assisted radical prostatectomy for treating locally advanced prostate cancer: protocol for an open-label, dose-escalation, single-centre, phase I clinical trial

alkiviadis.1961 shared this article with you from Inoreader Assessing the safety and feasibility of neoadjuvant hormone and radiation therapy followed by robot-assisted radical prostatectomy for treating locally advanced prostate cancer: protocol for an open-label, dose-escalation, single-centre, phase I clinical trial Via BMJ Open Current Issue Introduction Patients with locally advanced prostate cancer are at high risk of recurrence after definitive treatment. There are emerging data that radical prostatectomy can delay the progression of castration resistance and potentially prolong survival. Neoadjuvant radiation therapy improves local control and has shown survival benefit with favourable toxicity profiles in several other malignancies. We have designed this trial to investigate whether this combination, which theoretically maximises local control, is a safe and feasible approach for treating locally advanced prostate cancer. Methods and analysis This study is a phase I, open-label study to investigate the safety and feasibility of neoadjuvant hormone and radiation therapy followed by robot-assisted radical prostatectomy by a traditional 3+3 dose-escalation design with four planned radiation dose levels (39.6 Gy/22F, 45 Gy/25F, 50.4 Gy/28F and 54 Gy/30F). Locally advanced prostate cancer patients with positive pelvic and/or retroperitoneal lymph nodes will be recruited. The primary objective is to determine the adverse events and maximal tolerable dose (MTD) of neoadjuvant radiotherapy. Toxicity will be assessed using the National Cancer Institute Common Toxicity Criteria V.5.0. Ethics and dissemination This protocol was approved by the Institutional Review Board of Shanghai Changhai Hospital (ref. CHEC2019-070 and CHEC2019-082). The study will be performed in compliance with applicable local legislation and in accordance with the ethical principles developed by the World Medical Association in the Declaration of Helsinki 2013. Study results will be disseminated through conferences and peer-reviewed scientific journals. Trial registration numbers ChiCTR1900022716; ChiCTR1900022754. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study

alkiviadis.1961 shared this article with you from Inoreader Evaluation of the incidence of bleeding in patients prescribed rivaroxaban for the treatment and prevention of deep vein thrombosis and pulmonary embolism in UK secondary care: an observational cohort study Via BMJ Open Current Issue Objectives To evaluate the short-term (12 weeks) safety and utilisation of rivaroxaban prescribed to new-user adult patients for the treatment of deep vein thrombosis and pulmonary embolism and for the prevention of recurrent deep vein thrombosis and pulmonary embolism in a secondary care setting in England and Wales. Design An observational cohort study using the technique of Specialist Cohort Event Monitoring. Setting The Rivaroxaban Observational Safety Evaluation study was conducted across 87 participating National Health Service secondary care trusts in England and Wales. Participants 1532 patients treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism from September 2013 to January 2016. Interventions Non-interventional postauthorisation safety study of rivaroxaban. Primary and secondary outcome measures (1) Risk of major bleeding in gastrointestinal, intracranial, and urogenital sites and (2) risk of all major and clinically relevant non-major bleeds. Results Of a total of 4846 patients enrolled in the study from September 2013 to January 2016, 1532 were treated with rivaroxaban for the prevention and treatment of deep vein thrombosis/pulmonary embolism. The median age of the deep vein thrombosis/pulmonary embolism cohort was 63 years, and 54.6% were men. The risk of major bleeding within the gastrointestinal, urogenital and intracranial primary sites was 0.7% (n=11), 0.3% (n=5) and 0.1% (n=1), respectively. The risk of major bleeding in all sites was 1.5% (n=23) at a rate of 8.3 events per 100 patient-years. Conclusions In terms of the primary outcome risk of major bleeding in gastrointestinal, intracranial and urogenital sites, the risk estimates in the population using rivaroxaban for deep vein thrombosis/pulmonary embolism were low (<1%) and consistent with the risk estimated from clinical trial data and in routine clinical practice. Trial registration numbers ClinicalTrials.gov Registry (NCT01871194); ENCePP Registry (EUPAS3979). View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Acceptability of bisphosphonates among patients, clinicians and managers: a systematic review and framework synthesis

alkiviadis.1961 shared this article with you from Inoreader Acceptability of bisphosphonates among patients, clinicians and managers: a systematic review and framework synthesis Via BMJ Open Current Issue Objective To explore the acceptability of different bisphosphonate regimens for the treatment of osteoporosis among patients, clinicians and managers, payers and academics. Design A systematic review of primary qualitative studies. Seven databases were searched from inception to July 2019. Screening, data extraction and quality assessment of full-articles selected for inclusion were performed independently by two authors. A framework synthesis was applied to extracted data based on the theoretical framework of acceptability (TFA). The TFA includes seven domains relating to sense-making, emotions, opportunity costs, burden, perceived effectiveness, ethicality and self-efficacy. Confidence in synthesis findings was assessed. Setting Any developed country healthcare setting. Participants Patients, healthcare professionals, managers, payers and academics. Intervention Experiences and views of oral and intravenous bisphosphonates. Results Twenty-five studies were included, mostly describing perceptions of oral bisphosphonates. We identified, with high confidence, how patients and healthcare professionals make sense (coherence) of bisphosphonates by balancing perceptions of need against concerns, how uncertainty prevails about bisphosphonate perceived effectiveness and a number of individual and service factors that have potential to increase self-efficacy in recommending and adhering to bisphosphonates. We identified, with moderate confidence, that bisphosphonate taking induces concern, but has the potential to engender reassurance, and that both side effects and special instructions for taking oral bisphosphonates can result in treatment burden. Finally, we identified with low confidence that multimorbidity plays a role in people's perception of bisphosphonate acceptability. Conclusion By using the lens of acceptability, our findings demonstrate with high confidence that a theoretically informed, whole-system approach is necessary to both understand and improve adherence. Clinicians and patients need supporting to understand the need for bisphosphonates, and clinicians need to clarify to patients what constitutes bisphosphonate treatment success. Further research is needed to explore perspectives of male patients and those with multimorbidity receiving bisphosphonates, and patients receiving intravenous treatment. PROSPERO registration number CRD42019143526. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.