Eric Manasse

Cooks and recipes

The paper from Ranucci et al. [1] presents a new system of recalibration of the logistic EuroSCORE to be used in high-risk cardiac patients. It has a great merit of highlighting the importance of regularly updating the predictive models and validating them at a local level. To keep up with the pace of new technologies and proposed therapies and in order to avoid misinterpretations of the results achieved in ongoing clinical trials, we should evaluate if the models available today are still valid. In addition, a localisation of a riskassessment model makes it more valuable for actual decision makers who face real-life clinical situations in various environments. As both a medical doctor and a CMO of a medical device company, I recognise the value of customising a predictive model, especially when participating in the design of clinical studies. In addition to these points highlighted by Ranucci, an additional comment pertaining to the use of predictive models can be made. There might be a risk associated with inappropriately combining and analysing together discordant data when implementing different available predictive score models for different subsets of patients and diseases. This practice has sparked the current controversy regarding the appropriate models for patient selection and the associated patient outcome evaluation. Ranucci’s article, therefore, represents an opportunity for discussion about these and other aspects among all stakeholders. According to the users’ perspective, there are several reasons to have and implement a predictive risk score [2]. Patients need objective criteria with which they can make their own judgement on a proposed therapy. Health professionals wish to compare their results to the standard of care taking into account the different case-mix, so as to improve the standards of quality within the health institutions [3]. Local administrations base their rank list on adjusted results before possibly taking a necessary corrective action. The reimbursement authorities, in order to validate the incremental benefit offered by different therapeutic options, should be presented with comparable data. Finally, medical device companies, when applying to the regulatory bodies for marketing approval of a new product, need to define the targeted patient population. Historically, pre-