Talk Evidence
Talk Evidence covid-19 update - covid ethics, waste and a minimum RCT size
24 Apr 2020
For the next few months Talk Evidence is going to focus on the new corona virus pandemic. There is an enormous amount of uncertainty about the disease, what the symptoms are, fatality rate, treatment options, things we shouldn't be doing. We're going to try to get away from the headlines and talk about what we need to know - to hopefully give you some insight into these issues. This week: (1.00) Carl gives us an update on the UK’s covid-19 related mortality (7.40) When the evidence is uncertain, and the outcomes so massive, then the ethical dimensions of decisions become even more apparent. Helen talks ethics in guidelines with Julian Sheather, advisor on ethics and human rights to the BMA and MSF. (25.37) Update on covid-19 research, looking at viral particle shedding. (29.24) We’ve mentioned the potential wasted effort in covid-19 research, and Helen speaks to Paul Glaziou, director of the Institute for Evidence Based Research at Bond University, about the waste he’s already seen, and ways in which it could be avoided.
Chapter 1: What is the current status of COVID-19 mortality in the UK?
Welcome back to Talk Evidence, your weekly look at the evidence around coronavirus. Last week we focused very much on the ONS death data in the UK and we'll be getting a little update on that, but this week we are going to be looking a bit more broadly at ethics and generally at waste and research.
As always, I'm joined by our two favourite EBM nerds, Helen MacDonald, Resting GP and UK Research Editor for the BMJ. Hello, Helen.
Hi, Duncan.
And Carl Hennigan, GP, Professor at Oxford and Editor-in-Chief of BMJ EBM. Hi, Carl.
Chapter 2: How do ethical considerations influence COVID-19 guidelines?
Hi, Duncan.
As always, Carl, you've had another busy week and we saw you are talking to national media on Newsnight with David Spiegelhalter, who was our guest last week, talking a little bit about that ONS data. Now, David last week suggested that he thought there was going to be another peak because of the way that data is collected. Did we see some of that?
Yeah, no, it's very interesting. The Office for National Statistics, ONS, each week on a Tuesday updates their data set. And I have to say they're doing an amazing job in improving the granularity of their data, putting more evidence in. In what we call week 15, up to 10th of April, there were 18,516 deaths registered compared with a five-year average of 10,520.
So that's an excess of 7,996 deaths, 75% more than what we'd expect at this time. In week 14, we had 6,000 excess deaths. So it's ticked up again. And there are lots of very important caveats in the data. For instance, of the 7,996 excess deaths, 6,213, 78% mentioned COVID, but 22% did not mention COVID on the death certificates.
A couple of important issues as well is that greater than 70% of all the deaths occurred in over 75s. So this is disproportionately affecting elderly populations in a devastating way. But there's one really important issue I think within the coding that was very interesting for me was One of the aspects about SARS is it's the clues in the name, it's sudden acute respiratory syndrome.
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Chapter 3: What recent research updates are available on viral particle shedding?
So one of the things that I considered within SARS was that you were preparing for a viral pneumonia problem that required all the ventilators because you get this sudden acute respiratory problem that requires ventilation and oxygen. But the interesting issue is, if you look at all respiratory disease deaths, and they're coded ICD codes between J0099, you don't need to know that.
But in week 15, there were only 1,810 deaths with that code on their death certificate. And that's actually a decrease of 14% compared with the previous week.
Chapter 4: What is the impact of wasted efforts in COVID-19 research?
So that suggests that the majority of deaths that have been occurring are not predominantly respiratory and are caused by other conditions, because particularly on a death certificate, if it was pneumonia, you would have that on there. In a flu outbreak, when you get excess deaths, about one third of all deaths have pneumonia on their certificate.
So these raise important questions, I suppose, about the natural history of COVID, and we'll be wanting to pick that up in another episode, I think. One question that David, or three things that David thought might be suggesting some of the excess deaths there that didn't have a direct COVID-related line on the death certificate were,
because there were, we'd had a mild winter, and there were a lot of frail elderly people, we might have expected to die from flu or whatever else in that period, who didn't. The fact that there might be, you know, reluctance to diagnose COVID, if that wasn't absolutely the obvious cause of death.
And then finally, because there are these people who might not be going into hospital, even though they needed to. Did any of that become more clear?
Well, I think the proportion of people who have recorded went up from last week to 80%. So I think it's clearer that the coding is getting better. And actually, what you might see is a tendency to over-attribute now because COVID is everywhere. So the potential in hospitals is if you think a patient's had it, you're likely to put it on the death certificate.
What will happen in the lighter days when we come back is we can't tell this now. We'll be particularly looking at those that died from it versus those that died with it. And over the next six months, we'll be looking at the ONS data to look at what the overall pattern looks like. We have come in into the winter with a very mild seasonal effect.
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Chapter 5: How is ethical decision-making evolving during the pandemic?
So if you look at the overall data, it suggests we've got about 10,000 excess deaths for this point in the year, which is less than the COVID because there are less deaths from the seasonal effect of influenza. There's another thing also that happened this week that we think is a really positive move. NHS England have now started reporting their data by the date of death.
as opposed to the day that they get to find out about it. And that's incredibly important is when we get these daily announcements that says there's 680 deaths today, that doesn't actually mean that. What it means is we're being made aware of 688 deaths and they then get back a portion to which date they actually occurred. And that's incredibly important.
So like yesterday's went right back to 23rd of the March. We can't quite understand what's happening there. But actually, they're finding about deaths now that could have occurred a month ago. But when you do that, one of the things is if you look at the shape of the data now, the peak deaths occurred on the 8th of April. And it started to generally slow down.
The only caveat to that is the concerning picture that's happening in nursing homes. Because if you think about it, if a third of all nursing homes potentially have the infection, the mortality in that age group is incredibly high.
Chapter 6: What challenges do healthcare professionals face in resource-poor settings?
It could be 15%. And that's where you can get a sort of second spike in deaths because we have likely failed to shield nursing homes and that vulnerable population.
And you spoke about that last week, and I'm sure this is a topic we're going to be coming back to. Great. Well, there is a quick update on that data for you. So in talk evidence, we usually have some start stops. We're doing it slightly differently again this week. And Helen, you've started to think a bit more about the ethics in guidelines.
I have. We've talked a bit about the problems of guidelines in a crisis on this show before. And medical ethicists seem to me to be playing a more prominent role because I could see them being mentioned. And I've not noticed that before. And why is that? I think there's often reasonable quality evidence, which is quite key to informing guidance. And in COVID, this doesn't readily exist anymore.
And secondly, a lot of these public health recommendations which are being made around isolation and also clinical guidance on approaches to triage and escalation of care involve value judgments. So I was really intrigued to speak to ethicist Julian Sheather.
He's a medical and humanitarian ethicist working for the British Medical Association as well as for Médecins Sans Frontières and other NGOs. And I asked him about ethics, guidance and COVID-19 and asked him to share some of his ethical insights.
One of the extraordinary things about this pandemic has been the sheer scale of ethical problems that it's given rise to. The first thing you need to do is to be very, very alive to the fact that this is a value issue. It is not just a technical issue. It is not just a matter of doing sums. It's really saying, well, what are the values in place? Let's identify what values are in place.
So on the one hand, you know, economic goods are not just about cash. It's not just about cold, hard, indifferent cash. If we don't have a functioning economy, how do we fund the health service? These goods are profoundly interconnected and making these complex calls is a huge exercise in political ethics.
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Chapter 7: How can we improve the quality and coordination of COVID-19 research?
But we need to be clear, very, very clear that these are value based choices. And once we've identified that values are engaged, we can begin to dig down into what the actual issues are. You begin to see a big, big call on health services. Well, what happens if you have to choose between different people? Who gets access to fundamental life-saving goods, ventilators, ECMO machines?
All of these kinds of issues take on ethical ramifications at a slightly different level. And then you go down to individual clinician, patient-facing dilemmas.
And do you see the ethical issues being dealt with well on the whole?
Or how do you feel when you look at what's being put out there? I mean, one of the things at the moment is given some of the decisions that doctors may have to make, they're not making them now, we hope they don't ever have to make them. But given that they may have to make triage decisions in the future, we would like to see more national guidance, kind of joined up guidance.
The BMA stepped into the breach. We felt there was a clear need to prepare doctors for the kinds of problems they may have to face. But it would be great to see more national coordinated joined up guidance should that come about.
I think that's right, because it's hard to understand, isn't it? I think as a member of the public, why in one area you might be suitable for admission or escalation and then somewhere else you wouldn't be. That might feel quite unfair to people. So if we took the idea of triaging or rationing services, what are the key issues that guideline makers, national or local, should be thinking about?
I think one of the urgent issues here is to ensure that decisions are made on clinically relevant data and information. One of the things we're hearing, understandably, we're hearing a lot about is deep concerns among people from the disability communities. The very fact that they have a disability might itself disadvantage them, may mean that they are deprioritised for treatment.
We need to be absolutely clear that we identify what are the clinically relevant factors if triage becomes necessary. And that means that clinicians need to work very closely with ethicists because those are clinically relevant factors that need to be identified. We know, for example, that invasive treatment in ICU can be demanding, can be highly burdensome.
You wouldn't want to put people through that if they're not going to benefit from it or if the burdens are going to be overwhelming. So it's identifying clinically relevant factors without falling foul of inappropriate and potentially unlawful discrimination.
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Chapter 8: What lessons can we learn from the COVID-19 pandemic for future research?
I think a lot of clinicians will worry about... the legal implications of rationing decisions, which is why I think a lot of them would welcome national level guidance to assist and support them in that thinking, to be clear that they're using accepted and well thought through best practice.
To what extent do legal implications or ethical implications differ in a crisis situation or a situation that's sort of so
uncertain are there are there sort of special rules or special thinking that comes into play it's an interesting i mean what ordinarily in say clinical ethics in healthcare ethics the moral focus is always on the best interests of the individual patient but if you have a finite set of life sustaining health services and you get hit by overwhelming need
You do have to morally reorientate and say, these are very finite services. This is overwhelming need. How do we choose between these patients, all of whom have legitimate health needs, but we can't get anywhere near meeting all of it? How can we maximise the benefit from the resources we've got? And that's a brutal shift. And nobody wants to get there. We're not there at the moment.
We're hoping we don't get there. But that is a brutal shift. And that's what the guidance, for example, that we've been working on is designed to address. But it it means having to make potentially having to make some pretty wrenching decisions, heart wrenching decisions.
Julian, you've also done some work in lower resource settings. Yes. Tell us about the specific challenges that COVID is bringing up there.
I look at it with enormous trepidation. I've got to be honest with you. If you think of NGOs, organisations going into incredibly resource-poor settings, sub-Saharan Africa, the Central African Republic, countries that are just emerging from Ebola crisis, countries that have appalling shortages of even basic services, kind of health services.
And then over that you roll, or this tsunami of COVID-19 simply rolls across that. I find it terrifying, to be honest with you. But I'm hearing stories from... all over the world in resource-poor settings, saying clinicians are simply going to have no PPE. The supply lines are almost entirely shut off. They may have to withdraw from even providing the health
services that they've struggled to provide over recent decades. So I am profoundly concerned about it. And I don't think there's a single person with an eye on health services in resourceful settings that isn't looking at this with considerable alarm.
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