Informed consent and coronary heart disease
Informed consent is the cornerstone of good medical practice, where doctors and patients collaborate together to decide on treatment options that are most suited to both the healthcare needs, and wishes and preferences of individual patients.
Or, as it was put in the well known legal case of Montgomery: “An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo… The Doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”
What is to be done however, when the doctors themselves are not necessarily in possession of all of the facts?
A BBC Newsnight investigation has revealed that the European clinical guidelines on how to treat left main stem coronary artery disease are under review following revelations that some patients may have had the wrong advice.
It was previously thought that open cardiac surgery was the safer option in treating certain degrees of narrowing of the critical left main stem coronary artery, but Guidelines were drawn up on the basis of research demonstrating that both coronary artery stents (small metal springs, used to keep the artery open and deployed by a cardiologist in a less-invasive procedure) and open heart surgery to replace the damaged vessel were equally effective.
What Newsnight has revealed is that there was trial data which was not disclosed at the time of drawing up the Guidelines, which called into question the conclusion that stents and heart surgery were indeed equally effective. It is thought that as a result of making the wrong recommendations based on this research patients who have received stents will have died who otherwise would have lived for longer if they had had open heart surgery
It is interesting that The European Association for Cardio-thoracic Surgery (EACTS), which helped draw up the guidelines, told Newsnight that if the information on the trial is proven to be correct, “the recommendation is unsafe”, but reportedly The European Society of Cardiology, the other professional body involved in writing the guidelines, rejected the claim that the guidelines may have caused harm to patients. They stand by the guidelines, which they say were based on more than the trial.
Perhaps the more balanced response came from Prof Rod Stables, clinical lead for research at the British Heart Foundation, who reportedly said this information should have been published and knowing it would have made a “substantial contribution to our ability to appreciate the nuances of the results”.
Advising a patient on the options is a hugely important aspect of their care, and at the very least had the full information been made available cardiologists and cardiothoracic surgeons alike would be in a better position to advise. Every patient is different, and the circumstances will dictate which option is the least risky and most likely to provide benefit, but that advice must surely be given on the basis of full understanding of research data.
The Newsnight article can be found here, and is certainly worth a read for all of the issues which it raises, including those of potential conflicts of interest in research conduct.