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Out of the Dark Ages

It is remarkable to think that, until a couple of hundred years ago, medicine and its myriad forms of treatment were administered to patients almost as an act of faith. Much of early medicine had no basis in science or fact, and only in modern times have our treatments been supported by at least some hard evidence that they actually work. Once we have discovered effective treatments, an obvious next step would be to find out how well they are administered. Yet this is a question that had not even begun to be asked until the last couple of decades or so, when the scrutiny of medical outcomes began in earnest.

Today, most medical treatment is supported by scientific evidence, and most doctors claim to practise medicine that is ‘evidence-based’. We are therefore abundantly justified in beginning to ask the question I posed to my peers as a medical student: how well do those who treat us actually treat us?

I am now a heart surgeon, and proud of the fact. I know that I do many patients a lot of good (and a very few untold harm), but the net effect of my interventions, like that of most of my colleagues, is overwhelmingly positive. That said, I would not have been proud to be a surgeon, or indeed any kind of medical doctor, a hundred years or more ago. Many, if not most, of the medical treatments dished out with tremendous authority and style by my ancient predecessors to long-suffering patients over the centuries were not only useless, but actually downright harmful.

I am referring here not to quack doctors, ‘alternative medicine’ practitioners, homeopaths, and faith healers, but to properly qualified physicians who had sworn the Hippocratic Oath. These highly educated ‘doctors’ treated syphilis with mercury, a seriously toxic metal that did nothing to alleviate the disease. They managed a multitude of conditions with entirely useless bloodletting and leeches, and another multitude with enforced bed-rest cures and ludicrously long confinements to sanatoria. They performed unnecessary circumcisions, bowel removals, and many other dubious operations, causing horrific and often fatal infections by operating in filthy theatres with no sterility, asepsis, or even basic hygiene. To make matters worse, they usually carried out this carnage with supreme self-confidence. The idea that one should have some kind of proof of effectiveness before administering a treatment to a patient would have been alien to them.

In the past century, we have moved from this barely disguised witchcraft to therapies that actually work, allowing us more often than not to give the correct treatment for a particular condition. And, in the past two decades, we have seen the advent of a second revolution in healthcare: the long-overdue introduction of the concept of quality control in medicine. We have just started to ensure that, having chosen the correct treatment, it is delivered safely and well.

In this book, I explore how the concept of quality measurement came to be an essential part of medical and surgical practice. In the timeline of thousands of years of medical practice, good and bad, the concept was born only yesterday. For many years, the profession simply did not want to know about measures of quality. As I discovered to my cost a mere three decades ago, even asking the question about the quality of healthcare delivery was sufficient to produce ostracism.*

[* In the grand scheme of things, my blacklisting for surgical jobs was a fairly mild form of victimisation. I merely stopped looking for training posts in the region surrounding my teaching hospital and applied for two posts in other cities, much further away. I was immediately offered them both, and the pleasant dilemma was which one to choose.]

Ironically, these events took place at the same hospital where, a few years later, a failure of quality control exploded into a scandal that brought about a sea change in medical practice and attitudes. What’s more, the scandal involved the specialty in which I eventually qualified: heart surgery.

The first intimations that things were not as they should be in the Bristol paediatric heart surgery came on 8 May 1992, when the British satirical magazine Private Eye first drew attention to the high mortality of heart surgery in children at the Bristol Royal Infirmary. The professional who, at great risk to himself and his medical career, helped expose the scandal at Bristol was Dr Steve Bolsin. When he was appointed as a consultant anaesthetist in Bristol in 1988, he saw a charming city in an idyllic setting in which he and his wife, Maggie, would raise their family. He never expected Bristol, as he put it, to become the graveyard of his dreams at the same time as it became the graveyard of many children who could have survived if they had been operated on elsewhere.

Soon after starting to work in the department of paediatric heart surgery in Bristol, Bolsin noticed that the operations were taking an inordinately long time and that the survival rate was not as good as he thought it should be. A few months later, an audit meeting of the paediatric cardiac surgical specialists confirmed his suspicions that the death rates in Bristol were abnormally high. These were not small differences: death rates were many times greater in Bristol than should be expected, and that was true for even some standard, relatively simple heart operations. In the case of some of the more intricate, newly developed operations, the death rate was absolutely appalling.

He also made another shocking discovery: it soon became apparent to him that the poor standards and results were something of an open secret. Many people ‘in the know’ fully realised that Bristol was endangering children’s lives in its heart surgery programme, yet most of them refrained from blowing the whistle and took no remedial action. The professionals in the field talked about it, and, in some cases, physicians took active steps to avoid sending their own patients to Bristol. For the cities of Cardiff and Plymouth, Bristol was geographically the closest paediatric heart unit, yet the children’s heart specialists there were sending their patients to Southampton, a heart unit much further away. In fact, the children from Wales and their families would have to drive past Bristol to reach Southampton for surgery.

Despite all this, little was done to address the problem in Bristol for several years, and it was only through the courage of Bolsin that the situation ultimately came to a head. After personally investigating and reviewing the data, he expressed his concerns several times within the department, and beyond the department to the hospital management structure. On all occasions, he was given the brush-off, and, on some occasions, he was threatened. Finally, he blew the whistle.*

[* Bolsin found it impossible to continue living and working in Bristol, and left the country for Australia. His account of the events leading to the scandal appears in Appendix A.]

These disclosures made medical history. They led to a massive healthcare scandal and a public inquiry specifically and poignantly centred on the poor results achieved by paediatric heart surgeons. The scale of the inquiry was unprecedented. The families of children with heart defects treated in Bristol were invited to give evidence. In addition, the inquiry heard from Bristol doctors, healthcare workers, and managers. Medical experts from other centres and representatives of specialist organisations and colleges from around the nation were also called in as witnesses. The total cost was estimated at around £15 million. The report was published in 2001. It revealed that, between 1984 and 1995, the lives of as many as 171 children could have been spared if they had been operated on anywhere other than Bristol. The report also made 198 recommendations dealing with the need for robust monitoring of outcomes, transparency of medical-outcome data, and a host of other issues related to the quality of care. Along with the public outcry at the scandal, these recommendations contributed to the transformation of the culture that had prevailed in medicine at the time. The medical profession had been served with a wake-up call. From then on, it became unacceptable to treat patients with no regard to the standard of clinical outcomes. The pernicious combination of secrecy, complacency, and arrogance that had afflicted much of the medical establishment in the past was at last under effective assault. The concept of quality measurement in medicine had arrived.

Besides the Bristol scandal, there are several other reasons why heart surgery has driven advances in this field. For a start, the specialty involves a relatively limited number of operations, with coronary bypass and valve operations accounting for most of our work. It also has a performance outcome that is easily measurable and difficult to argue with: survival (or death, depending on your outlook). What’s more, the specialty has been measuring these outcomes since its inception — as a relatively young specialty, it could only develop by demonstrating outcomes good enough to justify its invasive approach, which originally involved great risk relative to conventional drug treatment. Finally, heart surgery has well-developed risk models that allow us to predict the likely outcome of treatment. By comparing the predicted outcome with the actual outcome, we have a pretty good idea how well (or badly) we are doing.

What is amazing about heart surgery is not that it exists and works, but that it took so long to appear. After all, the heart is a pump, pure and simple. When something goes wrong with a pump, it is a plumbing problem, needing plumbing solutions. How else do you fix a blockage in a pipe, or a leaky valve? Yet, for more than 2000 years, the heart was exclusively the domain of the physician, not the surgeon, and woe betide the surgeon who dared touch it. The taboo on operating on the heart was so strong that Theodor Billroth, one of the great founding fathers of modern surgery, stated in 1889 that ‘a surgeon who tries to suture a heart wound deserves to lose the esteem of his colleagues’.

There were two main reasons why the heart could not be tackled surgically. The first actually had to do with the lungs. These are the sponge-like organs that exchange gases with the air. They inflate and deflate a dozen times a minute to bring in oxygen and get rid of carbon dioxide. The problem is that the lungs do not do this by themselves, because they are entirely passive structures. The lungs inflate and deflate only by following the chest wall around them as it expands and contracts with the muscles of breathing. There is a sealed vacuum between the lungs and the chest wall, so that the lungs must follow the movements of the chest wall with every breath. Opening the chest to operate on anything inside it breaks that seal and lets air into the cavity. The lungs then fall away from the chest wall, and breathing stops immediately. At first, our intrepid pioneering heart surgeon would have been pleased to see this: there is suddenly a lot of room in the chest, and the heart can be easily reached. Sadly, his joy would have been short-lived, because the patient would have died a few minutes later from lack of oxygen. This was the fate of patients in whom chest surgery was attempted until the second half of the 19th century, when the endotracheal tube was invented. By inserting this tube into the windpipe (trachea), air or oxygen could be actively blown into the lungs. This made a lot of anaesthesia safer and more controlled. It also made major open-chest operations possible for the first time.

The second reason was the heart itself. This little muscle, about the size of your fist, pumps five litres of blood every minute to deliver oxygen and nourishment to the entire body. In fact, the average adult only has about five litres of blood in total, so your entire lifeblood goes full circle around your whole body every single minute of your life. If the heart stops, death follows almost immediately, as the body cannot live without a blood supply. Different parts of the body, however, are not equally sensitive to the loss of their blood supply for a short while. Your leg will probably recover if its blood supply is cut for half an hour, but your brain most certainly will not normally survive more than a few minutes without blood and oxygen.

Operating on the heart involves touching it, twisting it, pressing on it, and sometimes turning it upside down. All of these manoeuvres interfere with the pumping action, so any heart operation that disrupted the pumping action of the heart for more than a few minutes was likely to cause brain damage or death. Thus, the only operations that could be done on the heart were ultra-short ones: a few minutes to cobble up a hole and hope for the best marked the limit of what heart surgeons could do. This unhappy state of affairs remained until the middle of the 20th century, when the heart–lung machine was invented: a contraption that took over the job of the heart and lungs, keeping the patient alive while surgeons fiddled with the heart. After the first successful use of the machine, in 1953 by John Gibbon in Philadelphia, USA, everything changed: this marvellous invention opened the door wide and ushered in the new specialty of cardiac surgery.

The invention of the heart–lung machine was to heart surgery as the starter pistol is to an Olympic sprint runner. The specialty took off and ran with breathtaking, almost indecent, speed, so that, by the 1960s, heart surgery was no longer considered crazy. More and more patients were being saved, more sophisticated and complex operations were being invented, and the results were looking better and better. The specialty was transformed from a very limited last-ditch intervention in otherwise hopeless cases to a routine part of modern medicine’s armamentarium. Not surprisingly, units specialising in heart surgery mushroomed in major hospitals in many countries fortunate enough to have access to the resources for high-tech (and expensive) healthcare.

In the early 1980s, when I was working as a medical house officer at the Bristol Royal Infirmary, the heart surgery unit was a truly intimidating place. Mere medical house officers like me were the lowest of the low in the pecking order of hospital medicine, and were probably not welcomed there. Even if we had been welcomed, we were profoundly ignorant of what went on behind the door with the forbidding sign ‘Cardiac intensive care unit — do not enter’. Heart surgery formed no part of our undergraduate medical curriculum because it was considered too specialised and newfangled for mere student doctors. Nevertheless, whenever my bosses, the cardiology consultant physicians, decided that one of our patients could perhaps benefit from having a heart operation, it was my duty as a house officer and general gofer to deliver the carefully written referral note to one of the cardiac surgeons.

Even in my complete ignorance of cardiac surgery and utter obliviousness of its outcomes, I could not help noticing that there was a tendency to insist on referral to a particular surgeon in certain cases. Perhaps these were difficult cases, or patients that the cardiologist cared deeply about, but occasionally I would be given this instruction: ‘Make sure this referral goes to Mr Wisheart and nobody else. We want this one to live.’

Several years later, Mr Wisheart, a senior surgeon, found himself at the centre of the Bristol heart scandal. He was struck off the medical register for, among other reasons, having too high a death rate for certain operations. His subjective reputation among the local cardiologists was clearly not borne out by the hard data. The whole episode graphically illustrates the dangers inherent in not knowing if the quality of clinical outcomes is failing to reach acceptable standards, and in not acting when that knowledge becomes available. Much has changed for the better since then. Bristol is now considered to be a centre of excellence, and other heart surgery units have also improved massively as a result of the lessons learned from Bristol.

Together with quality measurement, the concept of clinical governance was introduced as a result of the Bristol event, and is now accepted as essential for the conduct of medical care. Clinical governance places the responsibility of clinical outcomes directly on the shoulders of the senior figures running the organisation. It means that, for the first time, hospital management simply must care about the way patients are treated by doctors.

What is incredible to the outside observer is that this concept was not enshrined in healthcare previously. Of course, doctors and nurses, as a general rule, ‘did their best’, and patients, as a general rule, were eternally grateful, but how good was that ‘best’? The simple answer is: nobody knew, because nobody had a robust tool by which the performance of a hospital, a medical unit, or an individual surgeon could be measured.