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Objective To investigate (1) the UK-wide inactivated influenza vaccine (IIV) uptake in adults with inflammatory bowel disease (IBD), (2) the association between vaccination against influenza and IBD flare and (3) the effectiveness of IIV in preventing morbidity and mortality.Design Data for adults with IBD diagnosed before the 1 September 2018 were extracted from the Clinical Practice Research Datalink Gold. We calculated the proportion of people vaccinated against seasonal influenza in the 2018–2019 influenza cycle. To investigate vaccine effectiveness, we calculated the propensity score (PS) for vaccination and conducted Cox proportional hazard regression with inverse-probability treatment weighting on PS. We employed self-controlled case series analysis to investigate the association between vaccination and IBD flare.Results Data for 13 631 people with IBD (50.4% male, mean age 52.9 years) were included. Fifty percent were vaccinated during the influenza cycle, while 32.1% were vaccinated on time, that is, before the seasonal influenza virus circulated in the community. IIV was associated with reduced all-cause mortality (aHR (95% CI): 0.73 (0.55,0.97) but not hospitalisation for pneumonia (aHR (95% CI) 0.52 (0.20–1.37), including in the influenza active period (aHR (95% CI) 0.48 (0.18–1.27)). Administration of the IIV was not associated with IBD flare.Conclusion The uptake of influenza vaccine was low in people with IBD, and the majority were not vaccinated before influenza virus circulated in the community. Vaccination with the IIV was not associated with IBD flare. These findings add to the evidence to promote vaccination against influenza in people with IBD.

Objective Cardiac troponin is used as a prognostic biomarker after cardiac surgery. However, numerous confounding elements, such as inflammation, liver and renal function biomarkers, have been associated with troponin variations. Furthermore, several thresholds regarding the definition of myocardial infarction have been suggested. We aimed to confirm the accuracy of troponin, analysed as time-dependent variable, to predict mortality independently from other biomarkers; and to assess the incidence and prognosis of a 10 times upper normal value threshold (troponin10N) used in the current fourth definition of myocardial infarction.Methods In a prospective cohort of patients who underwent cardiopulmonary bypass cardiac procedures, we assessed the association between serum levels of troponin, creatinine, bilirubin, serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), C-reactive protein (CRP), lactate and in-hospital mortality. Several models were tested, including time-dependent Cox regression, survival and latent class analyses. Repetitive measurements were accounted for.Results We included 3857 patients. In-hospital mortality was 2.8%. Troponin was independently associated with mortality in all models, after adjusting for other biomarkers. Of note, troponin10N was reached in 3830/3857 (99.3%) of patients. Similarly, renal function was independently associated with mortality. Conversely, CRP and liver biomarkers were not associated with mortality, once adjusting for other confounders.Conclusion We confirmed that troponin increase was independently associated with mortality after cardiac surgery. This association was independent of inflammatory syndrome and renal and liver failure. Troponin10N was reached in almost all patients, questioning the relevance of this criterion to define postoperative myocardial infarctions after cardiac surgery.

Introduction The combination of a CDK4/6 inhibitor with an aromatase inhibitor (AI) has recently become the gold standard for AI-sensitive first line treatment of oestrogen receptor-positive (ER+) HER2-negative (HER2−) advanced breast cancer. However, most patients receiving this combination will ultimately progress and require further therapies.Several studies have demonstrated that the onset of a ESR1 gene mutation lead to AIs resistance in the advanced setting. ESR1 mutations can be detected in circulating tumour DNA (ctDNA) using a digital PCR assay. Our study aims to prove the clinical efficacy of periodic monitoring for emerging or rise of ESR1 mutations in ctDNA to trigger an early change from AI plus palbociclib to fulvestrant plus palbociclib treatment while assessing global safety.Methods PADA-1 is a randomised, open-label, multicentric, phase III trial conducted in patients receiving AI and palbociclib as first line therapy for metastatic ER +HER2- breast cancer. 1000 patients will be included and treated with palbociclib in combination with an AI. Patients will be screened for circulating blood ESR1 mutation detection at regular intervals. Patients for whom a rising circulating ESR1 mutation is detected without tumour progression (up to N=200) will be randomised (1:1) between (1) Arm A: no modification of therapy; and (2) Arm B: palbociclib in combination with fulvestrant, a selective ER down-regulator. At tumour progression, an optional crossover will be offered to patients randomised in arm A. The coprimary endpoints are (1) Grade ≥3 haematological toxicities and their associations with baseline characteristics and (2) progression-free survival in randomised patients.Ethics and dissemination The study has been approved by the French medicines agency (ANSM) and by an ethics committee (ref 01/17_1 CPP Ouest-IV Nantes) in January 2017. The trial results will be published in academic conference presentations and international peer-reviewed journals.Trial registration numbers EudraCT: 2016-004360-18; NCT03079011.