Data scientist a été déclaré le travail le plus « sexy » du xxi e siècle par la Harvard Business Review . En quoi l’exploitation des données de masse peut-elle révolutionner les services financiers et leurs tarifications ? Quels sont les freins au déploiement du big data et quelles sont les pressions ? En dépit de nombreuses limites en France, des opportunités apparaissent, qu’il faut saisir aujourd’hui. Classification JEL : G20, L11, L86, L96.
IntroductionExpanded-criteria donors (ECDs) are used to reduce the shortage of kidneys for transplantation. However, kidneys from ECDs are associated with an increased risk of delayed graft function (DGF), a risk factor for allograft loss and mortality. HYPOREME will be a multicentre randomised controlled trial (RCT) comparing targeted hypothermia to normothermia in ECDs, in a country where the use of machine perfusion for organ storage is the standard of care. We hypothesise that hypothermia will decrease the incidence of DGF.Methods and analysisHYPOREME is a multicentre RCT comparing the effect on kidney function in recipients of targeted hypothermia (34°C–35°C) and normothermia (36.5°C–37.5°C) in the ECDs. The temperature intervention starts from randomisation and is maintained until aortic clamping in the operating room. We aim to enrol 289 ECDs in order to analyse the kidney function of 516 recipients in the 53 participating centres. The primary outcome is the occurrence of DGF in kidney recipients, defined as a requirement for renal replacement therapy within 7 days after transplantation (not counting a single session for hyperkalemia during the first 24 hours). Secondary outcomes include the proportion of patients with individual organs transplanted in each group; the number of organs transplanted from each ECD and the vital status and kidney function of the recipients 7 days, 28 days, 3 months and 1 year after transplantation. An interim analysis is planned after the enrolment of 258 kidney recipients.Ethics and disseminationThe trial was approved by the ethics committee of the French Intensive Care Society (CE-SRLF-16-07) on 26 April 2016 and by the competent French authorities on 20 April 2016 (Comité de Protection des Personnes-TOURS-Région Centre-Ouest 1, registration #2016-S3). Findings will be published in peer-reviewed journals and presented during national and international scientific meetings.Trial registration numberNCT03098706.
As clinicians, we are well aware that patients with prosthetic heart valves are complex ones and that their management should not be merely restricted to a problem of prothrombin time ratios. However our conclusion regarding the utility of an anticoagulation clinic in preventing thromboembolic events and haemorrhagic complications is correct. Of course any retrospective analysis has well known limits; nevertheless, the point raised by Girolami et al. was completely answered in the Data Analysis Section of our paper. The comparison of events occurring in patients in different periods of time (before and after enrollement in the anticoagulation clinic) was not carried out by means of the standard actuarial curve analysis, but through the method developed by Kurtze in 1989 as referred to in the paper, that overcomes this possible bias. According to the latter, the computation considers the curves with " a tale of two censors", taking into account the effect of time from the surgery on. So, the shape of the two curves (Fig. 2) is quite different.
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