European Society of Anaesthesiology Clinical Trials Network

According to the bylaws of the European Society of Anaesthesiology (ESA), one of the objectives of the ESA is ‘to raise standards of the speciality by fostering and encouraging education, research, scientific progress and the exchange of information’.1 One important activity of this mission is the annual Euroanesthesia meeting, as well as other educational programs. The Research Committee of the ESA (ESA-RC), which is responsible for fostering research and scientific development, writing in its current ‘policies and procedures’ has made the promotion of ‘research in anaesthesiology, pain, intensive care and perioperative medicine within the ESA with special emphasis on European collaborative research and development of young researchers’ its specific objective. Until recently, the ESA-RC promoted research by awarding grants for various scientific projects, mainly for young researchers. However, due to the relatively small size of the grants, most of the supported projects were limited to experimental and basic research. To date, support for clinical and, particularly, ‘European collaborative research’ has been lacking. It was, therefore, felt necessary to place more emphasis on multi-centre pan-European clinical research. Clinical research, and in particular the clinical trial, is the only way to bring innovation from bench to bedside. Clinical trials are indispensable in proving and validating hypotheses, whether generated in the laboratory or in the field. Randomised clinical trials are ideal, but there are many areas in medicine where these are difficult to perform.2 Moreover, thorough planning of randomised trials, mainly for calculating power, designing adequate group sizes, requires prior information about current clinical practice, and calculating the prevalence and incidence of morbidities and mortalities. These important a priori data are often sparse or unavailable. Last but not least, randomised clinical trials have to follow certain rules, and so called ‘Investigator Initiated Trials’ have to comply with the same good clinical practice standards as any trial sponsored by the pharmaceutical industry. Costs of multi-centre, interventional, randomised trials can easily run into millions of Euros, something that is way beyond the financial resources of the ESA. As a result, the ESA-RC has decided to start its new initiative with epidemiologic observational trials, but even if observational trials did cost less, the ESA would not have sufficient finances to fully sponsor such trials. However, it is our belief that there are enough enthusiastic anaesthesiologists out there who would be willing to donate some of their time to contribute to raising the ‘standards of the speciality by fostering research, scientific progress and exchange of information’. In the long run, we believe that once we have demonstrated that we are able to create a European Network for Clinical Trials, we will also be successful in securing third party funding, such as grants from the European Community. How should we proceed? As a start, the ESA has made use of its ‘scientific brain’, the Scientific Subcommittees, a pan-European group of highly qualified enthusiastic experts committed to both science and the European ideal. The Chairmen of these subcommittees were asked to consult their expert panels and come up with suggestions for topics which they considered clinically relevant. Out of these primary suggestions, the ESA-RC chose six topics and then a second call for concrete projects was advertised publically. To the pleasure of the ESA-RC, several applications were received, all of them of very good quality with high clinical relevance. Abandoning our initial idea, which was just to pick one from all the applications, we finally decided to start with four projects. Clinical trials are always risky and the likelihood that at least one of the four would succeed is much higher than just for one single trial. However, supporting four instead of one means the financial support for each trial will be much less. However, this is not as important as it seems because the ESA depends on the enthusiasm and the commitment of the centres. The research team have to invest their time and effort as part of their scientific engagement. What do we hope for? Of course, we hope that this very first venture of the ESA in true European collaborative research will be a success. Also, we hope that the investigators will enjoy meeting other colleagues from Europe and find new friends who share the same enthusiasm for our discipline. And, we hope that the ESA Clinical Trials Network (CTN) leads to future independent research activity, funded by third parties. In this journal, the protocols of the first four clinical trials, supported by the ESA, are published,3–6 and of course we hope that many anaesthesiologists from all over Europe will register as centres to participate in these studies. The European Surgical Outcomes Study (EuSOS) is driven by Rupert Pearse3 from London together with colleagues from Portugal, Italy, Germany, France, Austria and Belgium. EuSOS is designed to investigate the outcome of patients undergoing non-cardiac surgery across Europe. Surprisingly, little is known about the outcomes across Europe and, particularly, about the impact of varying practices such as availability of intermediate care and intensive care facilities on the outcomes. This study is, therefore, a focus of interest for the European Society of Intensive Care Medicine (ESICM). In fact, EuSOS is a joint study of the ESICM and the ESA, with both societies contributing equally. EuSOS is a good example of true pan-European collaboration. The study is very ambitious, as the goal is to recruit more than 20 000 patients, preferably in more than 350 centres. Frankly, at first we were sceptical as to whether it would be possible to recruit so many centres, but the status of the current list of those who have already declared their interest in EuSOS makes us much more confident. Still, the more the better, anybody is still welcome to sign up for EuSOS. Become an ESA researcher! The European Observational Study on Chronic Post Surgical Pain (EuCPSP) deals with a clinical problem which in our opinion has been neglected for much too long.4 It is estimated that 5–10% of surgical patients develop severe chronic pain. Approximately 40 million patients undergo surgery annually in Europe, meaning 2–4 million patients with chronic pain every year! This seems hard to believe, but this number itself demonstrates that solid epidemiological data are required. The group behind the EuCSPS project is the ‘Improvement in postoperative PAIN OUTcome (PAIN-OUT)’ group headed by Dominique Fletcher from Paris. PAIN-OUT is already an established European network, capable of earning significant funds from the European Union in its own right. However, the original PAIN-OUT study was limited to pain management in the hospital setting. EuCPSP has become a ‘piggyback’ study, enlarging the time frame of observation into long-term follow-up for assessment of the development of chronic pain after surgery. It is hoped that EuCPSP will help us understand the factors contributing to chronic post-surgical pain, a prerequisite for future strategies for its prevention. The Occurrence of Bleeding and Thrombosis during Antiplatelet In Noncardiac surgery (OBTAIN) is a study of the occurrence of bleeding and thrombosis during dual anti-platelet therapy in patients with coronary stents.5 The key question to be answered is whether continuation of dual anti-platelet therapy in these patients throughout the perioperative period is beneficial (fewer major cardiac events) or harmful (more bleeding). Current practice varies broadly, as this question is still a matter of debate. In fact, OBTAIN relies on this ‘natural’ variation of practice, as OBTAIN is a prospective observational study. If current practice varies sufficiently, then patients can be matched later on by propensity scoring, which is not as good as prospective randomisation, but almost. The Predicting Postoperative Pulmonary Complications in Europe (PERISCOPE) study has almost proven its success in advance.6 In the December 2010 issue of European Journal of Anaesthesiology, Canet et al.7 published a very similar study, in which they impressively demonstrated the usefulness of a simple score to predict post-operative pulmonary complications. Such a score would be extremely useful, as identifying patients at risk is always the first step for the development of preventive therapeutic strategies. However, previous work of Canet et al. had one minor weakness: their score is validated only for Catalonians! Thus, some important ‘homework’ still needs to be done, namely the validation of the score in a large European population. Who knows whether ethnic (unlikely), cultural or climatic differences (possibly) will affect risk factors for pulmonary complications? In conclusion, all four trials of the ESA-CTN are well designed, promising and exciting. Take your opportunity to contribute to true European collaborative research, become an ESA-investigator and sign up for an ESA-CTN study! This article was checked and accepted by the Editors, but was not sent for external peer-review.