Health: Risk means exactly that

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The Independent Culture
EVERY PATIENT who accepts treatment from a doctor tacitly accepts that it involves risk. That is what "consent" means. We expect the treatment to make us better, but accept that it may make us worse. On that understanding, trust between doctor and patient is built.

That trust broke down at the North Staffordshire Hospital in Stoke-on- Trent, which found itself in the eye of a media storm last week after The Independent revealed that ministers had ordered an inquiry into research there.

The story in The Independent provoked outrage from this NHS hospital Trust, particularly over the comparison drawn with the Bristol heart babies case. There is no denying that the disclosure of the inquiry, into an experimental ventilator treatment used on premature babies, raised acute difficulties for patients and staff at the hospital, who found themselves thrust unwillingly into the media spotlight. That is regrettable but it was, I submit, unavoidable.

In the same way the Bristol Royal Infirmary has also suffered, and will continue to suffer, as the inquiry there turns over the painful legacy of those babies who died after undergoing heart surgery.

Both institutions may fairly claim that they have been singled out for investigation, when the problems raised are common across the NHS. How many cardiac surgeons shook in their boots as they watched the events at the General Medical Council unfold during its inquiry into the Bristol case?

And now, how many doctors involved in medical research are thanking God and good fortune for sparing them the meticulous examination which Professor David Southall, the consultant paediatrician who led the controversial ventilator study in North Staffordshire, is about to undergo?

The blighting of institutions that do much good work is a heavy price to pay. But both inquiries raise issues of critical importance to the conduct of medicine in modern Britain. And, despite the protests of the North Staffordshire Trust, the parallels between the two inquiries are eerily close.

There is a widely held, but mistaken, belief that the three doctors involved in the Bristol case were found to be incompetent. They were not. They were convicted by the professional conduct committee of the General Medical Council - which (as its name implies) is empowered to judge the conduct of doctors, not their competence - of allowing operations on babies to continue for too long, when they should have stopped following warnings from colleagues.

The GMC case focused on a high-risk group of 53 babies, of whom 33 died or were brain-damaged. Many would have died anyway. James Wisheart, the senior surgeon, was also found guilty of misleading parents about the risks and, by implication, invalidating their consent to surgery.

In North Staffordshire, 122 babies were treated on the experimental ventilator, of whom 43 died or were brain-damaged compared with a control group of 122, of whom 32 died or were brain-damaged. Although the difference was not statistically significant, it was not good news. One question for the inquiry is whether the study was allowed to continue when it should have been obvious that it was having no benefit.

The third and most difficult question is whether proper, informed consent was obtained from the parents. In Bristol, parents were given an exaggerated idea of the success rate of the surgeons, in order to persuade them to let the operations go ahead.

In North Staffordshire, it is alleged, parents were told that the new ventilator was the "safest, gentlest" option, by researchers apparently anxious to persuade them to take it up.

One major difference is that the North Staffordshire parents, unlike the Bristol ones, were being invited to participate in a trial.

The latest edition of the GMC's guidelines on consent, which was published last week, says that participants in such trials should understand that it is research, that the results are not predictable and that the researchers "must not put pressure on anyone to take part".

How these admirable principles are to be applied in the context of a study of premature babies who are born unable to breathe is unclear. Any parent, when told that their newborn baby may be about to die, is almost bound to give carte blanche to doctors to do as they think best. As Professor Richard Cook, a leading neonatologist at Alderhey Hospital, Liverpool, pointed out last week, obtaining consent in these circumstances is fraught with difficulties.

If the North Staffordshire inquiry can come up with some sensible answers in this area, then it will have served an important purpose.

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