The guidelines for preoperative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery were produced jointly by the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA) and have been seen as an important step in the harmonisation of perioperative management in Europe.1–3 Shocking news came on 17 November 2011 that the chairperson of the guidelines taskforce, Professor Don Poldermans, was dismissed from his university position on the basis of scientific misconduct.4,5 An internal committee from the Erasmus institution had made inquiries about his clinical studies. Due to their time limitations, they recommended a more thorough investigation into some publications. However, their conclusion was that ‘he be relieved of any further responsibility for scientific research’.5
Don Poldermans was highly respected and his research group produced apparently well designed prospective randomised studies and made extensive use of their clinical database.6,7 They had provided a substantial contribution to the perioperative literature, especially on the use of perioperative medication. The guidelines were not produced by a single centre but by a large group of clinicians with academic backgrounds, which can be seen from the list of authors.1,2 The evidence base for the guidelines was, however, undermined by this event. Evidence is not abundant in the perioperative field due to a great number of confounding factors. The individual skills of the attending physician may be of decisive importance. Some factors, however, can be controlled and Poldermans et al.6,7 had focused on such variables. The relevance and quality of ‘evidence’ is dependent on study question, methods, statistics, selection of patients and finally whether the study results can be generalised into clinical management, that is the applicability of a study. Despite their many shortcomings, published studies are the best we have for recommendations. The dismissal of the Chair of the task force committee was not only an aesthetic problem. When an internationally renowned academic is dismissed, it indicates a serious crime despite the fact that the full extent of the scientific misconduct is not known.
The most recent extensive and serious single event of fraudulent publication in perioperative medicine resulted in the retraction of more than 80 papers authored by Dr Boldt in Germany.8,9 At present, we do not know the full extent of what has happened in Rotterdam, but there are no indications that the situation is of the same scale and gravity. However, the on-going Decrease VI study was stopped due to the ‘lack of participant patients’ written informed consent, which is in breach both of the legislations and regulations, and of the protocol approved by the METC; the method of data collection, the fabrication of data, and the method of reporting through the submitting of untrustworthy abstracts, all of which the Committee qualifies as academic misconduct’.5
The local committee found shortcomings in other studies and they recommended continued inquiries.5 Concerning the Decrease II study, there were flaws in informed consent procedures; in two studies, there were serious breaches of protocol and inconsistency of data collection. Despite the statement that no deliberate steering of research results was found, and that no patient seems to have been subjected to unwarranted treatment or examinations, inevitably, all studies of Poldermans et al. have now come under suspicion. As only one man was incriminated, it might be unwarranted and seems to be unfair. Until we know more, this must be the case.
Are the ESC/ESA guidelines still valid? Six days after the affair became known, the ESC issued a statement saying that there were no reasons for retracting the guidelines.10 The past-president of the ESA, Professor Paolo Pelosi, however, stated in the ESA newsletter11 that the ESA was committed to contributing to: the revision of the guidelines; supplying the best possible guidance to practitioners in Anaesthesiology and Intensive Care Medicine to improve medical practice and ensure patients to receive the best treatment; and informing ESA members on ongoing developments. Meanwhile, the ESA recommends, for the time being, that the guidelines should be followed.
The ESC initiated the guidelines, provided most of the manpower and carried the major financial burden. Anaesthesiology has a joint responsibility through the ESA-appointed members of the taskforce (Drs De Hert, Pelosi and Sellevold). They aimed to carefully evaluate all the available evidence and assessment of level of evidence and grade of recommendation were made by consensus. A Chairperson can have a decisive influence on the end-product. In this case, the Chairman's primary focus was on core issues of the guidelines, among others, the use of perioperative medication such as β-blockers, statins, methods of preoperative evaluation and coronary revascularisation.1,6,7
Trust is at stake. The clinical and scientific medical community has everything to lose from scientific misconduct and, therefore, damage control is vital. Guidelines are not like a single paper that can pass into oblivion. They should be used and cited. If one paper in a long reference list was found to be fraudulent, it would probably not only affect the end-product but when the Chair of the Guidelines committee is under suspicion, the whole product will also fall into the same category.
There are options. The guidelines can be claimed to valid, as the ESC has done.10 However, the Erasmus University has left no-one in doubt about its attitude to scientific misconduct by dismissing the professor. There are few arguments in favour of the medical community leaving a different message. We are now approaching 1 year since the news broke. The Guidelines were first published in 20091 and an update is legitimate in any case. Scientific fraud undermines the foundations of evidence. Doping in sports can only be stopped by a clear message from the authorities that there is no tolerance and that results are nullified. The medical community must signal the same attitude towards fraud. The best way is to abandon the guidelines – or at least nullify the old by substituting them with new ones – as soon as possible. Sometimes drastic measures are needed to restore and maintain confidence, despite the costs.
Assistance with the letter: the author is grateful for valuable discussions with Paolo Pelosi, Stephan de Hert and Pierre Foëx.
Financial support and sponsorship: none declared.
Conflicts of interest: OFMS was a co-author of the guidelines for preoperative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery.
1. Poldermans D, Bax JJ, Boersma E, et al. Guidelines for preoperative cardiac risk assessment and perioperative cardiac management in noncardiac surgery. Task Force for Preoperative Cardiac Risk Assessment and Perioperative Cardiac Management in Noncardiac Surgery of the European Society of Cardiology (ESC). Eur Heart J
2. Poldermans D, Bax JJ, Boersma E, et al. Guidelines for preoperative cardiac risk assessment and perioperative cardiac management in noncardiac surgery. The Task Force for Preoperative Cardiac Risk Assessment and Perioperative Cardiac Management in Non-cardiac Surgery of the European Society of Cardiology (ESC) and endorsed by the European Society of Anaesthesiology (ESA). Eur J Anaesthesiol
3. Sellevold OFM, De Hert S, Pelosi P. A major step forward: guidelines for the management of cardiac patients for noncardiac surgery – the art of anaesthesia. Eur J Anaesthesiol
6. Poldermans D, Bax JJ, Schouten O, et al. Should major vascular surgery be delayed because of preoperative cardiac testing in intermediate-risk patients receiving beta-blocker therapy with tight heart rate control? J Am Coll Cardiol
7. Poldermans D, Boersma E, Bax JJ, et al. The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. N Engl J Med
8. Tramèr MR. The Boldt debacle. Eur J Anaesthesiol
9. Tramèr MR. Ethical requirements and authorship: not much room for interpretation. Eur J Anaesthesiol