Is research good for your health?

Back in the nineties, I was involved in a study in France into ways of calculating risk factors in maternity services. The first step was to define what we meant by a good or bad outcomes in childbirth, so we could answer the question, “we want to measure risk, but the risk of what?”

What could possibly go wrong?
We were trying to measure the ways it might

One of the bad outcomes we looked at was postpartum haemorrhage – bleeding after childbirth. But that too required definition, because there is some bleeding in any childbirth. The study decided we'd regard any blood loss exceeding 500 millilitres as a haemorrhage.

One of the obstetricians involved in the study decided that she wanted to use graduated pouches to catch and measure any blood lost. The midwives in weren’t happy with this idea, since their professional experience meant they could assess whether a patient was haemorrhaging or not just by observing them, without anything so coldly technical as a pouch. But the obstetrician overrode them.

At the time, fathers weren’t allowed into that hospital’s delivery suites. So as soon as a baby was born, the midwife would nip out into the corridor with it and, in the obstetrician’s words, coo over it with the father. The mother, in the meantime, would be left on the table, possibly bleeding away.

Using the pouches put an end to all that. One of the effects, unsurprising to anyone but the midwives, was that it turned out they were actually missing a great many cases of haemorrhage, professional experience or not. But far more important was the fact that the midwives had to stay behind to fit the pouches, which meant they were looking after the women.

The rate of readmissions to the hospital for postpartum anaemia dropped massively.

The mere fact of looking into the problem had led to an improvement in patient care.

Those memories made it particularly interesting for me to listen to a conference presentation that talked about a classic paper by Sharon K. Inouye and others, ‘A Multicomponent Intervention to Prevent Delirium in Hospitalized Older Patients’. It was published in the New England Journal of Medicine in 1999.

Seminal study
But its flaw may be as interesting as its conclusions

The study compared the outcomes for elderly patients given specific interventions targeted at a range of problems leading to delirium, compared to two other groups receiving ‘usual care’. It found that some of the interventions genuinely prevented the onset of delirium, though the likelihood of recurrence of delirium and the severity of any delirium suffered, was pretty much the same in both groups.

The conclusion was that it was important to prevent the initial occurrence of delirium, and the interventions were effective.

What the speaker, Dr Andrew Severn, a senior anaesthetist from University Hospital of Morecambe Bay NHS Trust, pointed out was that the apparent division between the groups, intervention and control, was nothing like as rigid as might be expected. The study mentions that overall, across both the target and the control group, rates of delirium were lower than would normally be expected in the population generally. What’s more, there was a drop in the usual-care group – not as substantial as in the intervention group but still significant. The conclusion? There’d been some contamination between the groups: some of the interventions from the target group had somehow spread into the control group. As the study paper explains:

Although efforts were made to avoid contamination, some intervention protocols were disseminated by word of mouth to staff members in usual-care units. Moreover, although the intervention strategies most often involved the nursing staff, the physicians rotated on all hospital floors and carried over some of the intervention protocols to the usual-care group.

This sounds like a flaw in the study. But, in reality, it’s something far more significant: what it’s demonstrating is that the nurses using the new interventions were talking to their colleagues working with the control patients, and the latter were saying, “hey! That’s a good idea. I’m going to do that too.”

The same was happening to the doctors, simply by virtue of the fact that they were treating both groups.

In other words, good ideas were being tested in this study. The care professionals involved were identifying the ideas as good and simply couldn’t wait until the end of the study to apply them. As a consequence, the mere fact of researching enhancements in care was leading to better care.

Like my postpartum haemorrhage project, it’s an excellent example of the Hawthorne effect: work observed is work improved.

Interestingly, Dr Severn spoke right after a patient involved in a clinical trial. She said that her inclusion in the project, on its own, had improved her health. She now knew she was being monitored. She could get attention when she needed it. She realised that she might be in the group receiving the placebo rather than the active drug, but she felt better for being subject to more active care.

Yet further proof that research itself can be good for patient care. Whether or not it leads to a breakthrough…

How the Limeys beat Scurvy. Eventually

At a recent workshop on healthcare, a speaker quoted Professor Dermot Kelleher, Dean of Imperial College London:

If we did what we know and did it well, we would have a 20-30% improvement in patient outcomes.

It’s particularly striking that this view was expressed by Kelleher, who has won an international reputation as a researcher in medicine. Because what he seems to be saying is that sometimes we could achieve as much progress in medicine by just taking the knowledge we already have, without expensive research, and making sure we use it everywhere.

One of the best illustrations is in the treatment of Scurvy. It took a long time to get the research done. And we were slow to extend best practice. 

Scurvy used to be a major scourge among populations deprived of sources of vitamin C. Most notably, it affected sailors who were away from land for long periods of time and therefore deprived of fresh fruit and vegetables. Estimates suggest that as many as 2 million sailors died between 1500, as the age of European discovery got under way, and 1800 when an effective method of prevention was finally adopted.

It seems Scurvy was the main cause of the death of 116 out of 170 of Vasco da Gama’s crew, 208 out of 230 of Magellan’s and 1400 out of the 1900 the Royal Navy's George Anson took with him to circumnavigate the globe in the 1740s.

Yet already in 1593, a British Admiral was recommending the drinking of orange or lemon juice as a means of avoiding the disease. 

John Woodall: pioneer in the treatment of Scurvy
And one of the first to make a fortune from Pharmaceuticals

Then in 1614, John Woodall, surgeon-general of the East India company, published his handbook for apprentice ship’s surgeons, where he advocated combating Scurvy with fresh food, citrus fruit juices, or failing any of those, sulphuric acid: he shared the popular view of a time before the vitamin was known, that it was the acid element of citrus juices that produced the benefit.

Incidentally, Woodall became wealthy stocking medicine chests for the ships, proving that big Pharma has been an excellent business to be in for a long time now.

When the story gets most interesting is nearly a century and a half later, with the arrival on the scene of James Lind. While serving as a surgeon on HMS Salisbury in 1747, he treated twelve sailors who had been afflicted with Scurvy after two months at sea. He divided them into six groups of two, each receiving a different treatment (one of them being sulphuric acid). Only the two receiving citrus juice showed real benefit from the treatment, one of them fully fit to return to service and the other nearly recovered before the fruit ran out. The only other group to show improvement were the two being treated with cider.

Lind’s experiment is now generally seen as the world’s first ever clinical trial. Nowadays, we’d probably want slightly bigger groups than two, of course. Still, at least it was a serious empirical test.

James Lind. The world's first clinical trial
showed the efficacy of citrus fruit juice against Scurvy

It was greeted by the medical profession ashore in exactly the way one would expect such a trial to be received: medics stuck to their old view that Scurvy was a disease of “putrefaction” best treated by giving the body a bit of a fillip with such compounds as sulphuric acid.

Eventually, in 1794 senior officers were successful in demanding a daily ration of two-thirds of an ounce of lemon juice, apparently just about enough to provide the daily intake of Vitamin C required, for the crew of HMS Suffolk on a passage to India. Over the 23-week crossing, not a single crewman developed Scurvy.

The following year, the use of citrus juice became official policy throughout Royal Navy. By 1800 problems of supply had been resolved so that it could be made compulsory. Because the juice was often extracted from limes, it became quite common to refer to Brits as “Limeys” over the next century or two (perhaps occasionally with affection).

Five thousands sailors a year were dying of Scurvy. And yet John Woodall’s handbook was published in 1614. Even after James Lind’s clinical trial of 1747, it took another 48 years before the practice of using citrus juice became officially adopted, and then only in Britain.

That time lapse represents nearly quarter of a million lives lost to a disease whose treatment was known.

A good story, isn’t it? Doesn’t it make the point clearly about the need for good research? And even more strongly, for doing what we already know, doing it well, and doing it now?