Release for some, jeopardy for others

We’re emerging here in Valencia. Slowly. With a little optimism.

We’ve moved into phase 2 of the Lockdown relaxation process. With some justification. According to the Health Ministry, Spain has just had two days without a single Coronavirus death anywhere. Friends of ours from a few doors down the street tell us that their daughter, a nurse in the major local hospital, is being redeployed to Oncology after a couple of months in intensive care. The ICU beds are empty at the moment.

The only jarring note is that the Ministry has also warned that there are signs of an increase in infections as the restrictions relax. We’re clearly not quite out of the woods yet. It’s going to be face masks and social distancing for a while yet. Maybe even rubber gloves.

Still, we needed to celebrate our entry into phase 2. And what better way to do it than to go back to the sea? Especially if we took advantage of the new regulations to go there with friends. So we drove to a lovely spot south of Valencia, El Saler, with Maria José and Santi, our near-neighbours and the parents of the no-longer-ICU nurse I mentioned before.

The beach at El Saler

The day started relatively grey, but that meant the temperature was ideal for walking, warm enough for tee shirts, cool enough to be comfortable. We started in an almost jungle-like nature reserve before heading for the beach where we could walk with our feet in the surf.

The Nature Reserve at El Saler

A forest dweller we met

The company was great, the place was glorious, and as we walked, so the clouds cleared and we finished the outing, back in the woods, with bright sunlight filtering through the tree cover.

Danielle and Maria José wandering into the sunlight

It was a fine way of celebrating our emergence into a freer life. And it lifted my mood which had been rather depressed by a Tweet I saw in the morning from Trisha Greenhalgh: “I’ve never been so scared. There. Is. No. Plan.”

When I first heard Trish Greenhalgh, she was giving a conference presentation of remarkable brilliance. So brilliant that I wrote a post about it at the time. She is one of the leading Public Health specialists in England and one of the most convincing experts on evidence-based medicine I’ve ever heard.

If she is worried about the government simply having no plan, it seems to me a lot of other people should be too.

There’s much to criticise the government for in Spain. It was painfully slow in recognising the seriousness of the crisis about to hit the country. As a result it did far too little to prepare for it and reacted far later than it should have. But when it awoke to what it had to do, it acted fast, decisively and effectively. The results are obvious, as we've been slowly emerging from lockdown for a month now, and have had two days without a death.

It won’t necessarily benefit the government. Its vote seems to be more or less holding up, but it certainly isn’t improving, and the Conservative opposition is progressing. Given how well the government’s performed, that hardly seems just, but politics is an unkind game.

Meanwhile, Britain has a government which, as Greenhalgh puts it, simply has. no. plan. It never has had a strategy, but has stumbled from crisis to crisis since the pandemic hit, making up policy on the hoof, inventing commitments out of thin air and then failing to honour them.

Now it’s relaxing a lockdown that was never as strict as Spain’s, and doing so far too early. Spain, with its slow start, long had a far worse record in deaths per million than the UK, but the gap is now so small that it looks as though Britain will move beyond Spain in a matter of days.

The hasty relaxation is happening only in England, I should say. Scotland, Wales and Northern Ireland, with better governments, are being more prudent. The fear, and it’s certainly Greenhalgh’s, is that the Cummings/Johnson English administration is opening the UK up to a second wave of infection. The population certainly doesn’t deserve that fate, but I fear that can only be fixed when it chooses itself a better government.

Meanwhile, over here we’re slowly moving towards a new normal. There’s no reason for complacency, so it involves a lot of use of face masks, of hand gel, even of gloves. But we can go out more, we can meet friends, we can even get our hair cut or go to the dentist.

The dentist, in fact, was the downside of our first day in Phase 2. After the visit to El Saler, I had to head into town – my first metro trip since March, with gloves and mask and an empty seat next to each seated passenger – to visit the dentist. Who proceeded to beat the daylights out of my jaw, far longer in my view than strictly necessary, since it never offered him the slightest resistance.

Still, it was a small price to pay for another step out of lockdown. I just hope it doesn’t lead to a surge of disease. As I hope there’s no new peak in England either. 

Let’s hope Greenhalgh’s fears prove unfounded.

Danielle and Maria José collecting seashells

Evidence-base medicine: the case against

No sooner had I finished a post extolling the merits of evidence-based medicine (EBM) than I found my certainty that it was unquestionable being decisively questioned by an outstanding presentation at the same conference. 

That was a challenging but refreshing experience.

Trisha Greenhalgh
an authority on evidence-based medicine and a challenging patient

Trisha Greenhalgh is Professor of Primary Care Health Sciences at Oxford University. That makes her a leading authority in this field. In fact, she was awarded the Order of the British Empire in 2001 for her work on evidence-based medicine. So when she speaks out about its limitations, she commands attention – certainly mine.

Not that she advocates turning our backs on evidence. She simply calls for us to make more use what she calls “patient evidence”. The “old-fashioned clinical method” asks a key question:

What do I know about this patient: her history, the examination, test results, how she reacted the last time she took this drug, her beliefs, her family circumstances, etc. And given all that, what evidence do I need?

Without knowledge of the patient, the clinician may well pick the wrong evidence. Greenhalgh feels that clinicians don’t apply “old fashioned clinical methods” anything like often enough, as became clear after her own hospitalisation following a serious bicycle accident. Here’s what happened as she subjectively perceived it:

I was riding my racing bike along the towpath. I was going about 20 miles an hour.

Something caught in my front wheel. The bike somersaulted into the air. I came down heavily on the concrete, landing on my arms and the back of my head.

I was very dazed. Both my arms were deformed and useless. My fingers were numb. My helmet was split.

This was converted by the hospital into the following “objective” narrative:

55 yr old female fell off her bike

The hospital chose to apply a guideline for an older woman at danger of a fall. 

The fractures to both her arms led to seven operations over four months. But after six months she had wasting of both hands, together with heaviness, clumsiness and hyperreflexia (excessively pronounced reflex reactions) in the legs.

The guideline didn’t provide for any kind of diagnostic testing to the spine but eventually an MRI scan was carried out, revealing a displacement of two discs in her cervical spine (the neck).

In passing, let me say that an American in the audience pointed out that in the States the spinal examination would certainly have been carried out (“and billed”, cried a voice in a distinctly English accent). But, as Greenhalgh made clear, it should have been carried out in Britain too. 

NICE, the National Institute for Health and Care Excellence, provides a guideline which includes an algorithm for Selection of adults for imaging of the cervical spine. It calls on staff dealing with “adults presenting to the emergency department who have sustained a head injury” to check on the presence of any of a series of risk factors, including “dangerous mechanism of injury (fall from over 1 metre or 5 stairs)” or “ejection from a motor vehicle”.

A bike is not a motor vehicle, but surely the key condition is the ejection. And since the bike rose high in the air, she fell from over a metre. Her point is that it takes judgement to decide which guideline to apply. It isn’t a simple mechanical process.

She decided to have surgery. But it seems that some “self-proclaimed experts in evidence-based medicine” told her:

You didn’t need that operation. Randomised clinical trials have shown that in cervical disc lesions, surgical groups didn’t do any better than conservatively managed groups.

She stressed that:

They said this without taking a full history, without asking what the examination or MRI findings were, and without acknowledging the inclusion/exclusion criteria for the trials.

Yep. Got to agree with Greenhalgh on that one

As an authority in the field, she dug out the trial report. It specifically excluded patients with obvious muscle wasting, from which she was suffering, or who had undergone a whiplash-type of injury.

Things got worse when she needed to treat the acute pain she suffered after the operation. The specific question was whether she should use an opioid-based analgesic or a non-steroidal anti-inflammatory drug (NSAID). The evidence-based view was:

Patient advised not to take NSAIDs for one month following surgery: “some evidence of delayed healing of bone repairs, and risk of bleeding is higher in the post-op period”

The evidence that NSAIDs slowed healing was from a 2011 study.

It was based on work on just 12 subjects.

All of whom were rats. And I don’t mean politicians. Rodents with long tails.

Greenhalgh, formerly an elite athlete, had plenty of experience of taking NSAIDs, even after bone fractures, with no evidence of delayed healing. As for opioids, she had taken them with some severe adverse reactions in the past, including itching and vomiting.

As she pointed out, the conclusion had to be:

In this patient, given the history, clinical picture and equivocal nature of the evidence, the benefit-harm balance is in favour of NSAIDs...

Her presentation reached two conclusions. One, she rightly maintained, was uncontroversial. Clinicians should ask themselves:

Is the management of this patient in these circumstances an appropriate (‘real’) or inappropriate (‘rubbish’) application of the principles of EBM?

The second conclusion is far more controversial and more interesting:

If we practice patient-focused, individualization of the evidence (also known as real EBM) we will often find that more research is not needed.

Perhaps the uncertainty in science is inherent.

Perhaps we need to return to old-fashioned clinical method and use EBM less comprehensively…

A challenging conclusion indeed. But if it stops clinicians allowing their view of the patient to be blinded by a mountain of not necessarily relevant evidence, that has to be good news for us all. Any of us might some day be patients.

Not that this means the need for evidence is less strong. Only that the application of evidence has to be guided by the real condition of the patient. Surely all clinicians would make that condition the starting point for medicine?

Wouldn’t they?